Workload Measurement Instrument for Cancer...

YOUR PEER-REVIEWED GUIDE TO GLOBAL CLINICAL TRIALS MANAGEMENT appliedclinicaltrialsonline.com

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Volume 20, Number 1 January 2011

INSID

E

The Future

of Obesity

Drug D

evelopment

➤ SITES

Reducing the Challenges of Study Coordination

Workload Measurement Instrument for Cancer Trials

Recruitment: African Americans in Clinical Trials

Also in this issue

■ 2011: A Challenge for the Biomedical Research Community?

■ Joint Manifesto Tries to Address Vicious Cycle

■ Discontent with IRBs

■ R&D Success Rate Continues to Fall

Complete contents on page 6

1992–2011

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Applied Clinical Trials is the authoritative, peer-reviewed resource and thought leader for the global community that de-signs, initiates, manages, conducts, and monitors clinical trials. Industry professionals learn effective and efficient solutions to strategic and tactical challenges within the tightly regulated, highly competitive pharma ceutical environment.

COMMENTARY

10 From the EditorIns and Outs of Being Social

Lisa Henderson

19 View from WashingtonResearch Community Faces New Challenges

Jill Wechsler

22 View from BrusselsThe New Year Brings Same Old Battles

Peter O’Donnell

26 Clinical Trial InsightsFrustration with IRB Bureaucracy & DespotismKenneth A. Getz

58 A Closing ThoughtDeteriorating Quality in Global Trials

Jean-Pierre Tassignon

CLINICAL TRIALS COMMUNITY

14 News

51 Business and People Update

54 Calendar of Events

MARKETPLACE

56 Showcase

57 Marketplace

55 Advertiser Index

VOLUME 20, NUMBER 1

SITES

36 Workload Measurement

Instrument

Mary Coffey Julie Berridge, James Lyddiard, and Jacqueline Briggs

A better understanding of the

time, staff, and financial resources

required to conduct clinical trials

is necessary.

42 Increase African

American Enrollment

Patricia Sanders

Recession and acquisitions can

compromise the efforts to recruit

hard-to-reach American minorities.

COVER STORY

30 Collaborative Staffing Model for Multiple SitesMary E. Larkin, Paul McGuigan, Denise Richards, Karen Blumenthal, Kerry Milaszewski, Laurie Higgins, Jill Schanuel, and Christen Long

Strategies that may reduce the challenges of study coordination.


A P P L I E D C L I N I C A L T R I A L SEditorial Advisory Board

The expertise of Editorial Advisory Board members is essential to the

credibility and integrity of Applied Clinical Trials. These clinical trials experts

share with the editors the wisdom gained through their experience in many

areas of drug development. EAB members review manuscripts, suggest top-

ics for coverage, and advise the editors on industry issues. All manuscripts

must first be submitted to the Editor-in-Chief, Applied Clinical Trials, 485

Route 1 South, Building F, First Floor, Iselin, NJ 08830 USA.

Kiran Avancha, PhD, RPhClinical Research PharmacistUniversity of Miami Hospital and Clinics/Sylvester Comprehensive Cancer CenterMiami, FL

Aaron F. Bartlone, MSVice President& Head of Global QualityUCBBrussels, Belgium

Maarten Beekman, MDVice President, Medical & Regulatory AffairsAstraZeneca Zoetermeer, Netherlands

Paul Bleicher, MD, PhDChief Medical OfficerHumedicaBoston, MA

Timothy Callahan, PhDChief Scientific OfficerBiomedical SystemsSaint Louis, MO

Jo Collier, MBChB, FFPMMedical DirectorClinical Science and PharmacokineticsQuotient ClinicalNottingham, UK

Francis P. CrawleyExecutive DirectorGood Clinical PracticeAlliance–EuropeKessel-Lo, Belgium

Domenico Criscuolo, MD, PhD, FFPMChief Executive OfficerGenovaxColleretto Giacosa, Italy

Edward Stewart Geary, MDVice President& Global Safety OfficerEisai Co., Ltd.Tokyo, Japan

Uwe Gudat, MDMedical DirectorOffice of Chief Medical OfficerMerck SeronoGeneva, Switzerland

Felix Khin-Maung-GyiPharmD, MBA, CIPChief Executive OfficerChesapeake Research Review, Inc.Columbia, MD

Michael R. Hamrell, PhD, RACPresidentMORIAH ConsultantsYorba Linda, CA

Erica J. Heath, CIP, MBAPresidentEthical and Independent Review Services, LLCSan Anselmo, CA

Tim M. Jaeger, MD, PhD, MBAHead of Commercial Operations EMEA & LATAMSwisslab LIS SolutionsRoche Diagnostics Ltd./Swisslab GmbHBerlin, Germany

Brian J. Koziol, PhDDirector, Project Management& Strategic OperationsAmgen Inc.Thousand Oaks, CA

Patricia E. Koziol, PhDPresidentPEK Associates, Inc.Holmdel, NJ

Jeffrey S. Litwin, MDExecutive Vice President & Chief Medical OfficerERTPhiladelphia, PA

Somesh Nigam, PhDVice PresidentHealthcare InformaticsMedical Devices & DiagnosticsJohnson & JohnsonNew Brunswick, NJ

Timothy Pratt, PhD, MBAPrincipalCRUCIAL Clinical/Business ConsultantsMinneapolis, MN

Stanley C. RogersExecutive Vice PresidentSMHW Associates, LLCLawrenceville, NJ

Richard Rubin, MDDirectorThe Vermont Clinical Study CenterBurlington, VT

Stephen Senn, PhDProfessor of StatisticsDepartment of StatisticsThe University of GlasgowGlasgow, UK

Johanna Schenk, MD, FFPMSenior Partner& Managing DirectorPharmaProjekthaus GmbH & Co. KGFrankfurt, Germany

Albert J. Siemens, PhDChairmanNovella Clinical Inc.Research Triangle Park, NC

Thomas Sudhop, MDDirector and ProfessorFederal Institute for Drugsand Medical DevicesBonn, Germany

John R. Vogel, PhDDrug Development ConsultantJohn R. Vogel Associates, Inc.Kihei, HI

Glen de VriesPresident Medidata Solutions WorldwideNew York, NY

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Lisa Henderson

Editor-in-Chief

email: [email protected]

www.appliedclinicaltrialsonline.com

From the Editor

Just like any technology, big

purchase, or business need, there

has to be a benefit for you to sign on.

For better or worse, websites make it

easier for people to be out there and

have information more accessible.

The better? Humorous rants from Dr.

Grumpy’s blog spot, and movie ratings

with detailed reasons behind the PG-13.

The worse? Bullying on Facebook.

I’m what is technically termed, a

late majority technology adopter. The

iPhone was introduced January 9, 2007.

I bought my iPhone 3G in March 2010. I

love it. But I wasn’t convinced for a long

time. I prefer others to go forward and

try the technology, then let me know

what the best uses are.

Social media, the same thing. I’m

on Facebook, I understand the value,

but I keep my family life and work life

separate. I love my Mom, but the photo

of her cat isn’t really what I want under

my name and photo in all seriousness

as the editor of Applied Clinical Trials.

Others I have talked to about this

agreed and said that’s why they prefer

LinkedIn; it’s more professionally-

oriented. I have a LinkedIn account

also, but my activity level is low.

Twitter? For my personal life, no.

But for Applied Clinical Trials, the time

is right to start tweeting. The editors

are going to tweet what they read, and

what they observe. I am in the enviable

position of following and staying

abreast of the developments in a very

interesting industry. So why not share

what I find out? Find our insights

@trialsonline.

More for 2011 So while some of us struggle with the

importance of social media in general,

for our company, we are definitely

getting the hang of the best uses of this

medium for our online audiences and

how they can benefit.

The most interesting development

is a “social media” website that is

dedicated to one segment of the

industry. Don’t let the terminology fool

you. This is a very exciting project and

I don’t want to give all the details away

before it’s time. Suffice to say, bringing

together people who share a similar

interest and passion into a professional

online meeting place can provide the

true dialogue that our audiences seek.

2011 represents 20 years that Applied

Clinical Trials has been bringing people

together in the pages of the magazine.

We certainly have a successful

reputation and we think the time is right

to bring the audience closer together

in forums that will make positive

differences to your work life. We hope

you will join us.

For the socially stretched, look for real uses of social media that will make a difference to your work life.

In September, Psychology Today published an article “Revenge

of the Introvert.” The article noted that introverts and extraverts

are equally divided in the population, but introverts process

information and stimulus quite differently from extraverts. Introverts

are not shy, rather they just need more alone and quiet time. There

are millions on Facebook and maybe equally as many who could

care less about Facebook, and I wondered if this is in fact related.

Are introverts naturally—by predisposition—going to shun the

online party just like a real-life one? Social in and of itself can mean

extravert. Maybe social media is overwhelming for the introverts? The

choice is related to benefit and how best to use the information.

Ins and Outs of Being Social

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appliedclinicaltrialsonline.com

N O T E W O R T H Y

Go to:


to access these exclusive stories

and other featured content.

Biosimilars FDA UpdateA podcast interview with William

Egan, PhD, VP, and Jeffrey

Freitag, MD, SVP, PharmaNet

Consulting, provides a first-

hand update on the FDAs public

hearing on regulations for the

approval of generic versions of

biological products and what the

sponsor community can expect

moving forward.

Lönngren on EMAWilliam Looney, Editor-in-Chief

of Pharmaceutical Executive,

provides an excerpted interview

with Thomas Lönngren, depart-

ing EMA Executive Director, in a

December blog post.

Emerging Disease PathwaysPharmaFaceoff.com features a

recorded panel discussion on the

challenges related to drugs get-

ting to market. Specifically on the

table were complex trials, includ-

ing the need for more biomarkers

and upticks in personalized medi-

cine; increased regulatory hurdles

for pharmaceutical sponsors; and

outsourcing issues. Watch the dis-

cussion and leave your comments.

Competitive PressuresA September 2010 Wall Street Journal article outlined pressures among CROs,

specifically the mid-sized ones, that are advised to find better strategies to stay

competitive. While those same CROs will unofficially admit only that they are

large CROs, our informal sampling poll found more than half of the respondents

believe that mid-size CROs are being squeezed.

Synergy Research Group (SynRG),

a Russia-based CRO, released its

SynRG Orange Paper Q3 2010, a

quarterly analytical report on the clini-

cal trial market in Russia. The follow-

ing highlights are from the report.

The RZN approved 134 new clini-

cal trials of all types including local

and bioequivalence studies in the third

quarter of 2010—a 12% decrease com-

pared to last year’s figure.

The main contribution to the to-

tal number of studies is still made by

multinational, multicenter clinical tri-

als, even though the number of these

studies decreased by one third over Q3

2009 and stood at 60 new studies in Q3

2010. The number of local clinical trials

conducted in Russia by domestic and

foreign sponsors had a 7% increase and

stood at 42 trials.

Although most clinical trials in Rus-

sia are still being sponsored by for-

eign companies (57%), the ratio be-

tween foreign and domestic companies

changed significantly: in Q3 2009 their

shares were 67% and 33% respectively,

while in Q3 2010 the share of trials

sponsored by domestic companies in-

creased to 43%.

Clinical trials initiated in Q3 2010

were sponsored by manufacturers

from 17 countries. The largest num-

ber of trials were initiated by Russian

sponsors, American sponsors took the

runner-up place, followed by German

and Swiss sponsors.

Twelve new Phase I clinical tri -

als were launched in Q3 2010; while

the number of the Phase II trials de-

creased from 47 trials in Q3 2009 to 18

in the Q3 2010. The number of Phase

III trials also decreased over last year,

down from 86 to 61 studies, while the

number of Phase IV studies remained

unchanged at 10 new trials.

Is the mid-size CRO being squeezed by smaller specialty CROs and large CROs?

Yes54%

25%

21%

No

Not sure

Source: appliedclinicaltrialsonline.com survey, 12/06/10-12/20/10

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News

T H E R A P E U T I C C O R N E R

With New Year’s resolutions

still fresh in the mind, many

may have put “lose weight”

at the top of their list. Along with

gym enrollments, those who are very

overweight may have hoped to add

a prescription medication to their

regimen. However, what started out

in 2010 as potential new therapies

for obesity has turned into a murky

future for drug development in

this area. Sponsors with potential

therapies at the starting gate were

derailed by safety issues and even

an already approved and marketed

drug—Meridia in the United States—

has been pulled voluntarily by its

manufacturer, or forced out by global

regulatory authorities.

In January 2010, the EMA sus-

pended the marketing authorization

for sibutramine, known as Reductil,

Reduxade, and Zelium, across the

EU. This was based on the results of

a European postmarket request for a

cardiovascular outcome study due to

concerns raised in the clinical trial

data. The FDA then evaluated and

met on the SCOUT data in September,

and asked Abbott Laboratories to vol-

untarily withdrawal Meridia from the

market on October 8. In mid-Novem-

ber, India’s regulatory authority, the

Drugs Controller General of India, fol-

lowed suit and suspended formulations

related to sibutramine and r-sibutra-

mine imports and manufacturing.

Paul Aftring, VP and Global Head,

Endocrine and Metabolic Disorders at

i3, told Applied Clinical Trials that the

current climate for obesity drugs is

“difficult to say the least.” The reasons

why are directly related to these vari-

ous cardiovascular safety issues. How-

ever, when it comes to recruitment,

potential participants aren’t turning

away from clinical studies, even with

the historical cardiovascular events

related to these drugs.

“The condition is extraordinarily

prevalent,” said Aftring. “Finding sub-

jects to participate is easy.” Where the

trial becomes challenging is in subject

retention and global trials issues.

Retention and engagement“Obesity specialists are well aware

that this is a population that is hard

to keep engaged,” explained Aftring.

Much like any other weight-loss ap-

proach, if there is limited or slow suc-

cess, the person will lose interest. But

in a clinical trial, participation to the

end of the trial is required for the data

and the control group.

Aftring suggests using small re-

wards such as pedometers, which can

monitor activities even after the trial

is over, or cookbooks that can help

with diet. “You have to make sure you

aren’t creating undue influence,” said

Aftring, “but these types of things

can be used.” But outside of useful

tokens, what else can be done for the

obese subject?

Since not all investigators will be

obesity specialists, there is a need

to educate the site staff on engage-

ment and retention. Engagement can

come in the form of follow-up phone

calls, compliance to the study, and

encouragement on achievements, no

matter how small they are. There will

be weight loss achievements because

all subjects in an obesity clinical trial

will still be required to comply with the

standard of care, which is diet and ex-

ercise. Specifically, these trials call for

all subjects to limit their dietary fat to

30 percent. The difference, of course,

is some will be on placebo and others

on the experimental agent.

In order for the data to be measur-

able across a global trial in obesity,

however, is where conduct can become

complex. How does a measurement

becoming equalized when a subject is

instructed to take the agent before a

meal— members of one culture might

eat a number of small meals during

the day, and a large meal at night,

while another culture might feature

three large meals per day. “The chal-

lenge is how to get consistent results,”

said Aftring. “There are local nuances

that need to be addressed.” i3 wrote

and posted an article to its website

at www.i3global.com/spotlight/spot-

light03232010 that discusses these

global issues in detail, from variability

in diet and exercise to developing

those educational materials involved

across cultures.

With the challenges of a negative

risk-benefit ratio surrounding obesity

drugs due to increased cardiovascular

events, future development may lie

in the comorbid conditions in cardio-

vascular disease and type II diabetes.

Industry experts predict a dearth of

drugs for obesity, a similar 10-year

span that occurred with the fen-phen

safety issues in the 1990s. Aftring

notes there is much more activity on

the diabetes side of the endocrine

equation. In the end, it may be that

sponsors will focus on testing diabe-

tes drugs with better risk profiles, or

working toward obesity drugs that

have a novel mechanism. However,

trial managers can take the aforemen-

tioned advice from Aftring for cultural

nuances in a global trial. Applying

local and cultural norms in any trial is

necessary, as well as retention and en-

gagement strategies. These will not be

lost in current or future diabetes and

related trials.

Obesity Wins One, but Rest of Field Uncertain

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News

G L O B A L N E W S

GCP training will come under

the spotlight at the start of

February, when the European

Forum for GCP’s annual congress

takes place in Budapest, Hungary.

The two-day meeting will bring

together experts from a range of

clinical trial disciplines to discuss the

needs of the key players. The organiz-

ers’ prime aims are to exchange na-

tional and organizational experiences

and to devise constructive proposals

for meeting GCP training needs.

“Although the European Commis-

sion has established a comprehensive

regulatory package to ensure that

GCP principles apply to the conduct

of clinical trials within Europe, it is

very apparent that the practical imple-

mentation of this regulatory package

differs between member states,” state

the organizers.

Training must be appropriate for

each partner, whether it is an industry

or academic sponsor, ethics commit-

tee, competent authority, or investiga-

tor. This training is often inadequate,

inconsistent, and too theoretical. This

has to be addressed, as does the need

to ensure that patients and the public

are more aware of the benefits and

risks of taking part in studies involv-

ing the use of rigorous standards, ac-

cording to officers from the EFGCP.

Two important initiatives being con-

sidered by EFGCP are the creation of

a common curriculum and provision

of certification and accreditation. The

keynote address from Jean-Pierre

Tassignon, MD, PhD, President of

Crossover CRI (Zug, Switzerland),

will ask whether harmonized training

standards are really necessary.

The event, called “Certified GCP

Training—Needs and Solutions,”

is being held February 1- 2, and is

supported by the

Hungarian Clinical

Trial Management

Society. Its seven

workshops will ad-

dress e-GCP train-

ing, how to teach

clinical research to

medical students,

training of experi-

enced investigators

and responsibilities

for training their

teams, the suit-

ability of SOPs

as training tools,

how to train risk-

benefit assessment

in rare diseases,

the contribution of

patients in ethics

committees, and

special training for

research involving

older people and

geriatric patients.

The conference

will also include an

update on the Pa-

tientPartner project

to be given by Cor

Oosterwijk, PhD,

from The Neth-

erlands. PatientPartner is a three-

year European Union FP7 (Seventh

Framework Program) project investi-

gating, enforcing, and advising on the

role of patient organizations in clini-

cal trials (www.patientpartner-eu-

rope.eu). Its main goals are to make

inventories of the needs of patient

organizations; to identify and realize

common points of action amongst all

stakeholders by engaging in an ac-

tive dialogue; to realize the European

Network of Patients Partnering in

Clinical Research (ENPCR); to create

a European network for interaction

with the other stakeholders in the

clinical trial field; and to create Eu-

ropean, patient-centred guiding tools

and recommendations on how to cre-

ate a successful partnership.

PatientPartner organized a training

workshop in Brussels on December

7-8, 2010, and in his Budapest presen-

tation, Oosterwijk will present details

about the results of the workshop.

—Philip Ward

EFGCP to Establish Changes in GCP Training

LIV

IO S

INIB

ALD

I/G

ET

TY

IM

AG

ES

The European Forum for GCP’s annual congress will take place in Budapest, Hungary.

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News

L E T T E R T O T H E E D I T O R

D A T A A N A LY S I S

In the November 2010 issue of

Applied Clinical Trials, Viq Pervaaz

said “the pharmaceutical industry

has been ripe with merger and

acquisition activity for the last several

years.” As a tool in this economically

challenged period, M&A transactions

can make the difference between

a positive financial year and one

that is not. Recently, a clever way to

achieve a strong end of year finish

is via growth, competitive edge, and

M&A transactions. Acquisition in this

economic environment is a great option

to explore. However, for a cohesive,

seamless merger, it will take work and

planning, before, during, and after the

deal sheet is signed. Both sides must be

guided, informed, and M&A-ready. To

achieve a successful M&A, preparation

is necessary: understanding the

transaction, strategy alignment, and

utilization of success metrics specific to

the type of M&A is a great beginning.

Recently I was approached by

pharma to assess, manage, and

implement a more centralized, M&A-

ready clinical/regulatory approach

to “a combined” pipeline. With the

addition of a promising new pipeline,

clinical/regulatory operations

expanded considerably and rapidly;

overnight, fragmentation resulted. The

fragmentation generated operational

inefficiencies, lost timelines, increased

costs, and eventually lethargic worker

performance. Management lacked a

realistic view of what was expected of

them. Pre-existing business models did

not apply, quality was lost, and deadlines

were sacrificed in the expansion.

Gaps and stumbling blocks in each

pharma company are identified and

worked through to improve operations,

process, and quality standards. Data

and documentation audits focused on

short and long-term objectives, should

outline best practices.

How can this be accomplished?

Opportunities for improvement are

assessed and changes implemented.

The implementation plan is agreed

upon by all functions, all teams,

all CROs. An implementation

project planner, “a gate-keeper”

is developed to clearly execute

prioritized recommendations.

Bridging the gap between corporate

leaders and operational staff, team,

and functions is the main key to

improvement. Communicate and

monitor progress. Manage the

issues pertaining to resource and

capacity. Lead people with clear,

concise, well communicated vision

and realistic expectations. Nothing

is insurmountable when assessed,

planned, implemented, tracked, and

monitored prior to, during, and after

the M&A transaction. Lead people,

manage issues. Communicate.

Diane L. Mauriello, PhD

President

Dante Resources, Inc.

Throughout the entire

clinical development, who

has the most interaction

with prospective and active

subjects? Who is primarily

responsible for the quality of

the source data that ultimately

decides the approvability of all

biopharmaceutical products?

Yes, the answers are identical:

the site coordinator, study

coordinator, or clinical research

coordinator, whatever title you

choose. These individuals are

the keystone, the glue that holds

the study process together.

Without them very few patients would

be randomized, informed consent

forms would not be completed, site

contracts would not be negotiated,

data would not be entered, queries

would not get resolved, and database

lock would be delayed.

Delay is the key point. Site

coordinators help a study stay on

track. Without good ones, hitting

milestones would be nearly impossible.

ISR dedicated an entire study

(The Voice of the Site Coordinator—

www.isrreports.com/reports) to

understanding site coordinator’s

experiences and perspectives on

improving the success of clinical trials.

—Industry Standard Research

Site Coordinators: An Untapped Resource

Achieving a Successful M&A

51%

28%22%

SiteCoordinators

PrincipalInvestigators

Subjects

Source: Industry Standard Research

Principal investigators were asked who satisfaction surveys should focus on during a study. Site Coordinators were named more than half the time, ahead of PIs themselves.

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appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 19January 2011

To see more View from Washington articles, visit


View from Washington

Jill Wechsler

is the Washington editor

of Applied Clinical Trials,

(301) 656-4634

[email protected]

Research Community Faces New ChallengesNew user fees, health initiatives, and FDA compliance concerns are top issues for 2011.

The tension is mounting on

Capitol Hill, as Republicans

seek to cut the federal deficit by

squeezing resources for govern-

ment agencies, including the Food and

Drug Administration and the National

Institutes of Health. They’re looking for

opportunities to criticize lax regulatory

oversight that compromises product

and patient safety. Challenges to the

Obama administration’s health reform

program will create uncertainties for

biopharmaceutical companies about

whether new fees and policies will be

implemented as planned, or if industry

will have to pay stiffer rebates and

taxes without gaining the millions of

additional customers promised cover-

age under a reformed health insurance

system. Pressure on federal agencies to

obtain additional revenues, moreover,

will intensify government efforts to hit

violative companies with stiff fines and

to ratchet up user fees from industry.

Fees firstThe Prescription Drug User Fee Act

(PDUFA) has to be reauthorized by

October 1, 2012, for FDA to continue

collecting nearly $700 million in fees to

support the review process for drugs

and biologics. Although that legisla-

tive deadline may seem far away, FDA

wants to have a PDUFA V plan ready

for public review by fall in order to

transmit it to Congress early 2012;

failure to reauthorize user fees by next

summer theoretically would force FDA

to lay off hundreds of staffers and shut

down its drug review process.

Last April, FDA’s Center for Drug

Evaluation and Research (CDER)

launched a two-year process for revising

PDUFA. CDER Director Janet Wood-

cock noted that 65 percent of human

drug review funding comes from user

fees, a situation that some critics claim

makes the agency overly dependent on

industry. Yet, despite such qualms, no

one suggests that FDA curtail any activi-

ties or cancel the fee program.

Pharma and biotech companies of-

fered general support for user fees,

while pointing out that multiple post-

marketing requirements are slowing

down the drug review process and

undermining approval time frames.

Patient advocates, pharmacists, and

doctors agreed that the proliferation of

risk evaluation and mitigation strategies

(REMS) made drug development more

costly and complicated prescribing and

dispensing. Consumer groups focused

more on direct-to-consumer drug adver-

tising, seeking user fee support for man-

datory pre-review of DTC ads, clearer

prescribing information, better protec-

tion of patients in clinical trials, and full

disclosure of clinical trial results.

FDA has been discussing these and

other issues at meetings with manufac-

turers, patient and consumer groups,

and healthcare professionals and

academic experts, as part of a broad,

transparent consultative process re-

quired by the FDA Amendments Act

(FDAAA) of 2007. A main FDA goal

for PDUFA V is to gain more flexibility

in meeting review time frames and re-

sponding to sponsor meeting requests.

The agency has proposed to extend the

review clock for more complex applica-

tions, such as those with REMS, that

require advisory committee meetings,

or that involve inspections of foreign

manufacturing facilities—but that ap-

pears to cover most NDAs.

The overarching issue is to what

extent industry fees should fund FDA

initiatives to improve drug development

and regulatory science. FDA proposes

to tap fee revenues to increase staff

consultations on innovative clinical trial

designs, on utilizing biomarkers in drug

development, on complex manufacturing

issues, and to standardize electronic sub-

missions. The agency also seeks added

resources to support the Sentinel Active

Surveillance System, standards for meta-

analysis, rare disease programs, and

improved dose selection and safety as-

sessments. But this year’s fee to process

a new drug application (NDA) with clini-

cal data already exceeds $1.5 million, up

from $1.17 million in 2008, and sponsors

are wary that expanding the pool of

activities supported by PDUFA would

boost fees disproportionately.

Congress will address many of these

issues as it crafts a broader FDA re-

form bill to carry the PDUFA reautho-

rization. As with FDAAA, this “must-

pass” legislation is a prime candidate

to establish a host of new FDA policies

and programs: curbs on drug advertis-

ing, expanded drug reimportation,

refining the REMS program, requiring

new drugs to demonstrate compara-

tive superiority, and enhancing FDA

authority to pull drugs off the market

and to issue subpoenas, to name a few.

An FDA reform bill also may authorize

the collection of user fees for generic

drugs, an issue that has been discussed

for years and now has industry support.

View from Washington

Biosimilars and CER

Another important FDA initiative is to

establish standards and policies govern-

ing the development and approval of

“similar” versions of biotech therapies.

Patient and consumer groups and health

plans and payers are pressing for a clear

biosimilar development pathway to fa-

cilitate access to less costly therapies, a

goal that will be increasingly important

as more biologics come on the market.

FDA held a two-day public meeting in

November to launch the process for

establishing a framework for developing

biosimilars, as stipulated by the Afford-

able Care Act enacted last March 2010.

A long list of brand and generic drug

manufacturers testified on the scope

and size of preclinical and clinical tests

and data needed to document the safety

and efficacy of such products, and FDA

will be digesting these and other com-

ments over the coming months. FDA

officials appeared interested in identify-

ing a middle ground between ensuring

product safety and efficacy, and making

affordable new treatments available to

patients. However, Commissioner Ham-

burg indicated at a later meeting that a

complete approval pathway for biosimi-

lars may be elusive, as the science and

products will evolve continuously.

The health reform legislation also

expanded federal support for compara-

tive effectiveness research (CER), and

that initiative will begin to take shape

in the coming year. The governing

board for the Patient-Centered Out-

comes Research Institute (PCORI)

held its first meeting in November

where it adopted bylaws and explored

operating procedures. Its first tasks

are to hire an executive director and

staff, develop a communications plan,

and map how the strategy will work

with its Methodology Committee.

Before PCORI awards grants for

new CER projects, the Board wants

to assess what research and analysis

already is going on in this field and

where there are information gaps to fill.

The Department for Health and Human

Services (HHS), NIH, and the Agency

for Healthcare Research and Quality

have dispersed $1.1 billion for CER

projects over the last two years, and

most of these initiatives are up and run-

ning. PCORI’s “environmental scan”

could benefit from a planned HHS

initiative to establish an online CER

Healthcare fraud and abuse is a prime target as authorities look hard at all opportunities to save money and generate revenues.

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catalog, and from a database of feder-

ally funded CER projects being created

by the Partnership to Improve Patient

Care. The Board also would like to

review state and private CER initiatives

to better identify early projects that can

increase general understanding of CER

and further illuminate PCORI’s role.

Costs drive complianceBy steering patients and providers to

the most effective treatments, CER

advocates hope to improve healthcare

quality, while also reducing spending

on medical services and products. With

healthcare consuming an ever-growing

portion of federal and state budgets,

authorities are looking hard at all op-

portunities to save money and generate

revenues, and healthcare fraud and

abuse is a prime target. The Justice

Department announced in November

that it recouped $3 billion in civil settle-

ments and judgments last year, much

of it from pharmaceutical companies.

At the top of the list is Pfizer’s $2.3

billion settlement for promoting unap-

proved drug uses; Astra Zeneca agreed

to a $302 million civil settlement and

Novartis paid $193 million. FDA also

has been stepping up actions against in-

vestigators and research organizations

that violate the rules.

There’s no sign of any letup as

extensive pharma layoffs promise to

encourage more dismissed workers to

blow the whistle on corporate malfea-

sance. In October, GlaxoSmithKline

agreed to a $750 million settlement,

and Merck negotiated a $950 million

deal with the Justice Department to

settle marketing violations related to

Vioxx (on top of the $5.6 billion the

company has paid out to settle various

Vioxx lawsuits and claims).

Because stiff fines don’t seem to

compel some companies to toe the

line, the regulators and prosecutors

are weighing even harsher penalties.

One threat is to bring criminal charges

against corporate executives consid-

ered responsible for serious violations.

A former Glaxo executive is headed for

trial for making false statements and

blocking an FDA investigation; convic-

tion could bring a jail term as well as

fines. If that doesn’t compel companies

to clean up their acts, the feds also

are looking to ban companies commit-

ting fraud from doing business with

Medicare and Medicaid under a stiffer

federal exclusion policy.

In addition to waving the enforce-

ment stick, FDA leaders talk of more

guidance and assistance to help

companies meet quality and safety

standards and to bring high quality

drugs more quickly to patients. Efforts

by industry and regulators to find the

resources and appropriate policies to

achieve this objective will be in the

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To see more View from Brussels articles, visit


View from Brussels

Peter O’Donnell

is a freelance journalist

who specializes in

European health affairs

and is based in Brussels,

Belgium.

The New Year Brings Same Old BattlesAn alliance between two European leaders gives hope for unison but falls short on solutions.

As the glitz and warm

goodwill of the festive season

evaporate, drug firms and

drug regulators are once

again faced with the chilly reality of

their differences of view, still largely

unresolved as we move into the second

decade of the 21st century. The

clinical trial community is one of the

principal victims of these differences,

pincered between ever-increasing

demands for demonstration of value

and ever-tighter budgetary constraints

from cash-strapped sponsors.

The problem is depressingly fa-

miliar: growing healthcare demand,

rising healthcare costs, tougher

drug-launch criteria, squeezed com-

pany revenues, and pressure on R&D

budgets—at the same time, drug

development becomes harder and

more expensive. What makes it all the

harsher in this unhappy new year is

that the economic downturn is biting

severely into both public expenditure

and private-enterprise profits.

Two luminaries of the European

pharmaceutical scene—one from each

side of that traditional divide—made

an attempt to forge a new approach as

the old year came to an end. Andrew

Witty, the CEO of GlaxoSmithKline

and President of the European Federa-

tion of Pharmaceutical Industries and

Associations, and one of Europe’s top

regulators, John Dalli, the European

Union’s Commissioner for Health, is-

sued a sort of joint manifesto that tried

to square the classic vicious circle.

Their starting point was that policy-

makers and the pharmaceutical indus-

try across the European Union share

the goal that all citizens and patients

in Europe should enjoy equal access

to the right medicines and vaccines.

They offered a vision of the phar-

maceutical industry, policy makers,

health insurers, patients, and others,

working together to achieve that ob-

jective. Success, they claimed, would

result in healthier citizens, enhanced

competitiveness, more balanced bud-

gets, and fair reward for innovation.

“Valuable innovation can transform

lives,” they agreed.

A noble aspiration. At the broadest

level, the need for greater equality is

clear—as Dalli and Whitty remarked.

They pointed to the beneficial impact

of earlier diagnosis and new treat-

ments on cancer, where incidence is

increasing in the EU, but mortality is

decreasing. “There is significant vari-

ability in patient access and in relative

survival rates,” they went on to note.

“Similarly, we see wide variability

between member states in the speed

with which valuable innovative medi-

cines become available to patients,

and then further variability in uptake

between member states and between

disease areas.”

Aspiration is one thing. Delivery

is another. As the two European

pharma champions acknowledge,

the task of delivering equality across

Europe is not easy. “Health services

everywhere face enormous chal-

lenges. Governments are understand-

ably struggling to cope with rapid

demographic change, the pace of

technological change, and unbridled

demand for healthcare. The current

financial crisis exacerbates the dif-

ficulty of balancing desire for health-

care equality with the need for finan-

cial management.”

Against this background, they go

on, “governments need to maximize

public health outcome for a given bud-

get, and to make choices.”

This is the difficult bit—for pharma

companies struggling to get new

products onto the market, and equally

for health authorities harangued by

their publics.

European governments are focus-

sing on value for money, and rely

increasingly on processes like health

technology assessment for decision-

making. Dalli and Witty both say that

this is appropriate, but there are reser-

vations and hesitations.

“HTA requirements in different

member states vary considerably,

which causes complexity for industry.

The ongoing fragmentation of health-

care delivery in Europe introduces

further challenges,” they remark, in a

bold display of diplomatic harmony.

But as they advance in their argu-

ment, the underlying tensions inevita-

bly emerge.

Making it all the harsher in this unhappy new year is the economic downturn biting severly into both public expenditure and private-enterprise profits.

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View from Brussels

“In this challenging climate, it is

vital to achieve the best results for

patients across the European Union,

for public budgets and for industry,”

they say. They speak of “an equilib-

rium” between the needs of these

different players—but in the same

sentence they add: “with patients put

first”—immediately suggesting some

disequilibrium in the priority to be

allocated to each player. Reading this,

it is impossible to resist the thought

that all players are equal, but some

are more equal than others.

From that point onwards, their

joint manifesto starts to fray, with its

separate threads stitched tenuously

together only by the deployment of

well-meaning generalizations that

studiously avoid confrontation on the

difficult details.

“All stakeholders need to change

the way they think and act, with

‘health for all’ achieved collabora-

tively at local, national, and European

level,” they chorus blithely—and

innocuously, since the appeal is so

vague as to be meaningless.

“‘All for health’ should be the key

enabler—the more institutions work

in a trusting environment, the more

likely the right approaches can be de-

veloped,” they warble happily, allow-

ing sound to triumph over sense.

Where the manifesto addresses the

distinct needs of each “stakeholder,”

it does so in the same well-meaning

and inoffensive terms. “Industry must

be a genuine partner to governments

and their agencies,” it trills. Who

could take exception to its brotherly

expressions of mutual understand-

ing? Industry “must deliver new

medicines and vaccines that address

unmet patient need and have demon-

strable value.” Well yes, of course.

And how? “This means getting R&D

right—reversing the decline in pro-

ductivity and delivering medicines

that match the health needs of the

population.” Not wrong, of course,

but not sufficiently right either to

bring any illumination into the dark

realities of this debate. Similarly,

“industry must increase the transpar-

ency of what it does and be a source

of ideas to governments, including

on increasing funding and more ef-

ficient use of budgets.” Insofar as

this highly-nuanced and carefully se-

lected language conveys anything at

all, it seems to amount to little more

than an offer to industry to connive

with governments in engineering its

own downfall.

As a concession, as it were, to in-

dustry sensibilities, the passage con-

cludes: “The pharmaceutical industry

is hugely innovative. If governments

work to support innovation, the indus-

try will deliver the next era of revolu-

tionary medicine.”

That blandly optimistic formula-

tion is followed by another: “Govern-

ments have the key responsibility for

delivering equitable healthcare. It is

possible for them to encourage and

reward therapeutic progress, while

maintaining core characteristics

like equity, public funding, and strict

regulation.” It may indeed be pos-

sible. What would be more interest-

ing would be to know more about how

it is to be done.

The recipes proposed for success

remain largely at the same level of

pious exhortation and comfortable

banality. “We must create in Eu-

rope the right policy and regulatory

framework.” OK, what’s next? “This

requires that effective prevention

and wellness programs are in place.”

Safe, but vague. “We must shift focus

from cost to value, and set a strategic

agenda that addresses unmet needs.”

Difficult to fault, but difficult to deci-

pher, too.

There is some attempt to grapple

with the difficulties in establishing

a sense of value—but again, without

much real commitment to a discern-

ible course of action. There is talk of

“allowing industry to understand the

type of added value that matters to

patients and will be funded by pay-

ers,” and of “a shared understanding

of value” through “high quality dia-

logue between industry and authori-

ties.” Dalli and Witty (a coupling of

names that faintly suggests a comic

duo from the age of music hall, even

if their routine often seems short of a

punch line) see an important role for

health technology assessment in en-

suring that “the government does not

pay for medicines that do not work

but that equally, patients get access

to medicines that may help them.”

But how it should play this role is less

clear. “Closer cooperation” is one rec-

ommendation, immediately countered

by the remark that “a single approach

in the EU is undesirable, since mem-

ber states will want to make decisions

according to their own priorities.”

At the same time, “the current di-

versity and overlap leads to unequal

access for patients, complexity for

industry, duplication of work, and

unnecessary red tape.” This tangled

series of observations is hardly clari-

fied by the conclusion that “While the

final decision has to remain national,

in particular on price and reimburse-

ment, we should explore a common

methodology on the clinical aspects

of health technologies in Europe

which might then be used for assess-

ments of relative efficacy and effec-

tiveness at European level.”

So if clinical trial and pharmaceuti-

cal professionals were hoping that

this unusual outburst of ecumenism

in Brussels was going to make things

easier—or even just clearer—in the

new year, well, I’m very sorry. But

happy new year anyway. ❏

Reading their manifesto, it is impossible to resist the thought that all players are equal, but some are more equal than others.

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Clinical Trial Insights

Kenneth A. Getz

MBA, is a Senior Research

Fellow at the Tufts CSDD

and Chairman of CISCRP,

both in Boston, MA, email:

[email protected]

To see more Clinical Trial Insights articles, visit


Frustration with IRB Bureaucracy & DespotismDoing more harm than good will ultimately force human subject protection system reform.

My personal frustration

with institutional review

boards reached a boiling

point several months ago.

A dozen IRBs had each reviewed a

general educational brochure prepared

by the Center for Information and

Study on Clinical Research Participa-

tion (CISCRP). The brochure was not

specific to any clinical studies and its

focus was on explaining the risks and

benefits of clinical trial participation.

All IRBs had suggested revisions to

the educational language. But only one

of the 12 IRBs rejected it. The reason

for rejecting the brochure: Educational

material “…should not include the word

hope because the term is coercive.”

My deep frustration was felt on many

levels. The concept of “hope” is central

to patients and their families wanting

to consider and evaluate clinical trials

among their options. Just as risks can

be discussed openly and in a language

that the lay public understands, gen-

eral educational information must also

openly and honestly acknowledge the

potential benefits of participation. Why,

you might ask, were IRBs even review-

ing a general educational brochure

when it falls outside their jurisdic-

tion?1 As an independent non-profit,

CISCRP’s mission is to provide public

education to promote greater, more

balanced and informed understanding

and awareness of the clinical research

process. This is also part of the overall

mission of all human subject protection

programs. By rejecting CISCRP’s edu-

cational materials, was this IRB doing a

disservice to the very population that it

strives to protect?

I’m clearly not alone in my frustra-

tion. A large and growing number of

government and private-sector clini-

cal research professionals are voicing

their concerns and suggesting that

our current human subject protection

system is ripe for radical reform to

change its antiquated, fragmented, bu-

reaucratic, and over-reaching ways. A

number of peer-reviewed articles have

sounded the alarm including: Salim

Yusuf’s “Randomized Clinical trials:

Slow Death by a Thousand Unneces-

sary Policies?”2 and Christine Grady’s

“Do IRBs Protect Human Research

Participants?”3 This past year the Insti-

tute of Medicine has singled out IRBs

as one of the top barriers to achieving

efficiencies in clinical research. At a

meeting that I attended in October,

serious concerns were raised by aca-

demic and government leaders that

failures of the IRB system are actually

hindering the ethical protection of

study volunteers.

Too many cooksWhat’s wrong with the system? Or,

as some have rephrased the question,

what’s not wrong with it? Our nation’s

system of human subject protection

programs has evolved into a complex

regulatory and legal environment with

19 agencies in addition to the Food and

Drug Administration (FDA) sharing

oversight for protection of study par-

ticipants. These agencies include the

Social Security Administration and the

Department of Homeland Security. Af-

ter protracted debate, various agencies

adopted the Common Rule in 1991 to

harmonize human subject protection

policies. Many agencies subsequently

have added regulations while others

have adopted inconsistent guidance

on how to interpret the rule. The FDA

chose not to even adopt the Common

Rule, but did change its IRB and in-

formed consent regulations to more

closely correspond to federal policy.

Adding to the confusion is the fact that

IRBs must follow federal privacy re-

quirements and state laws. Some IRBs

must also balance compliance with

International Conference on Harmoni-

zation (ICH) guidelines for studies out-

side the United States. This complex

and crowded array of organizations

have burdened IRBs with substantial

inconsistencies in ethics regulations

and the challenge of complying with

many different and potentially conflict-

ing requirements.

Unnecessarily wastefulManaging that burden would be

enough. But there is the added weight

on research sponsors to reconcile

and coordinate wide and inconsistent

variation in ethical review decisions

across multiple IRBs. Current regula-

tions require that each institution and

investigative site involved in clinical

research receive IRB approval. An

ethical review of a single protocol for

a multicenter trial requires that many

IRBs conduct their own independent

reviews. Reviews of the same protocol

are not coordinated, they result in

contradictory recommendations and

outcomes, and they cost the research

sponsor and study staff substantial

time and resources.

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Clinical Trial Insights

Clinical research professionals in

both the public and private sectors

widely agree that our current multiple

IRB system is wasteful and causes

unnecessary delays. In a recent New

England Journal of Medicine edito-

rial, OHRP Director Jerry Menikoff,

said that duplicative reviews not only

provide “relatively few benefits,” but

the current structure actually might

lead to “less-than-optimal protection”

of those who volunteer to participate

in research.

Menikoff points out that the system

results in individual IRBs feeling

powerless to change the protocol

when risks are identified. If one IRB

has serious concerns about the study

design, it usually results in that IRB

leaving the study—either of its own

accord or after being dropped by the

sponsor—rather than resulting in a

change to the protocol.

Overreaching, overwhelmingA growing number of research

sponsors and investigative site staff

have expressed frustration and concern

about IRBs overseeing more than

their jurisdiction dictates. During the

past two decades, IRBs have asserted

themselves as gatekeepers of all

interactions with patients and the public

and the protectors of every possible

potential or imagined harm that might

occur during research. As such, IRBs

often impose burdensome, impractical,

unnecessary requirements in order to

err on the side of extreme caution.

Researchers and institutions com-

plain that IRBs are overly expansive in

interpreting regulatory requirements

and that they focus on inconsequen-

tial details during reviews. Others

complain that IRBs have been over-

whelmed with obligations that have

little to do with protection of research

participants, and IRB members tend

to focus more on procedures and

documentation than on difficult ethical

questions and serving patients’ and the

public’s best interests.

As clinical research has become

more complex and demanding, the

scope of IRB responsibilities has ex-

panded to include compliance with

privacy regulations, checking for poten-

tial financial conflicts of interest, and

reviewing the methodological sound-

ness and scientific merit of a study. Yet

as IRBs are asked to take on more re-

sponsibilities, they have been criticized

for becoming less effective and more

susceptible to questionable practices.

The now famous sting operation carried

out by the General Accounting Office

(GAO) in 2008 exposed a national hu-

man subject protection system vulner-

able to unethical manipulation.

IRB jurisdiction and authority is also

virtually never challenged or evaluated.

Few sponsors and investigative sites are

willing to question an IRB’s decisions

out of fear that the IRB might scrutinize

their proposal more closely or won’t

approve their research. The IRB’s deci-

sion is the gospel—taken without ques-

tion—despite the fact that nowhere in

the regulations is an appeal prohibited.

There is no data measuring whether

IRBs are doing their job in protecting

study volunteers from unnecessary

risk of harm. The IRB system, which

evolved from an institution-based struc-

ture with little accountability or data

collection, lacks even rudimentary met-

rics for measuring its own success.

Eventual reformThere’s no question that frustration

among all stakeholders is intensify-

ing and will eventually drive reform.

But structural and procedural re-

forms are likely a long way off given

such a complex, crowded, and heavily

regulated system.

Many ideas for IRB reform center

around streamlining and creating a

better, harmonized review process.

One approach would be for sponsors

to require the use of a central IRB as

a condition for sites to participate in a

study. Another proposal would change

the system to impose more demands on

early trials with new interventions while

simplifying the oversight of commonly

used interventions. Academic and gov-

ernment leaders have recommended

collecting more data in order to mea-

sure IRB performance.

The FDA and OHRP both support

the use of a single, central IRB for mul-

ticenter research. Drug sponsors have

increasingly contracted with central

IRBs to review studies conducted by

community-based investigative sites.

Most universities and hospitals still opt

to use their own internal IRBs when

conducting both privately and federally

funded research. OHRP is leading an

effort to coordinate guidelines across

various agencies, and plans to propose

the creation of a single new agency to

oversee all human subject research in

the United States.

As criticism and dissatisfaction

grows, our national IRB system has

been losing credibility and respect

among regulatory agencies, clinical re-

search professionals, patients, and the

public. Extreme frustration may drive

reform even sooner. After all, we owe it

to patients and the public to get this IRB

system, or a new one, working right. ❏

References1. Code of Federal Regulations, Title 21, Part

56, Section 102, 109 (US Government

Printing Office, Washington, DC).

2. S. Yusuf, “Randomized Clinical Trials:

Slow Death by a Thousand Unnecessary

Policies?” Canadian Medical Association

Journal, 171 (8) 889-892 (2204).

3. C. Grady, “Do IRBs Protect Human

Research Participants?” Journal of the

American Medicial Association, 304 (10)

1122-1123 (2010).

Clinical research professionals in the public and private sectors agree that our current multiple IRB system is wasteful and causes unnecessary delays.

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Sites

Collaborative Staffing Model for Multiple SitesReducing the challenges of study coordination in complex, multi-site clinical trials.

Mary E. Larkin, Paul McGuigan, Denise Richards, Karen Blumenthal,

Kerry Milaszewski, Laurie Higgins, Jill Schanuel, and Christen Long*

The implementation of complex,

multi-site clinical trials pres-

ents challenges that make re-

cruitment efforts, participant

follow-up, and organization of

staff critical to the success of the overall

outcome. This article describes a unique

staffing model utilized by the TODAY

(Treatment Options for type 2 Diabetes in Ado-

lescents and Youth) study, an NIH (National

Institutes of Health) sponsored trial designed

to explore treatment options for type 2 diabetes

in youth. At each study center, the program

coordinator (PC) and diabetes educator (DE)

work together to implement the study protocol.

A staffing model that provides this type of mu-

tual support for two key members of the study

team may decrease the burden customarily

encountered solely by the PC in complex trials,

and furthermore allows for cross-coverage and

flexibility. To determine the degree of overlap

and task sharing between the PC and DE across

study sites, a self-administered survey was dis-

tributed to all PCs and DEs. Survey results

as well as specif ic examples demonstrating

an effective collaborative approach by front-

line study personnel in managing various chal-

lenges encountered in study implementation

are included.

BackgroundThe TODAY study, which randomized its first

participant in 2004, aims to identify optimal

treatment regimens for type 2 diabetes specifi-

cally for adolescents and youth, as incidence

has dramatically increased.1-4 The study follows

an ethnically diverse group of 704 overweight

youth (aged 10-17 at enrollment) with new on-

set type 2 diabetes (less than two years

duration) for a minimum of two to six

years at 15 clinical centers across the

United States. The goal is to compare

the efficacy of three treatment arms (two

medication-only arms and one intensive

lifestyle intervention combined with med-

ication arm) on glycemic control.3 Study

participants have routine medical visits

every two months for the first year and quarterly

thereafter. Interim medical visits are scheduled

as needed for management of comorbidities or

reinvigoration of diabetes management.

The study participants are adolescents and

their families who are coping with a new diagno-

sis of type 2 diabetes, and are also typically deal-

ing with extreme socioeconomic challenges, psy-

chiatric problems, and/or other chronic health

concerns. Many of them have life circumstances

that are inherently unstable; the recent diag-

nosis of a chronic illness creates additional dis-

ruptions in their lifestyles. It is not unusual for

them to present a number of pressing issues at

each study visit requiring extensive interaction

with personnel with two distinct protocol-driven

roles: PCs and DEs.

Unlike the typical staffing model in large clini-

cal trials where the designated PC assumes most

of the responsibility for the daily work of imple-

menting the protocol,5 in the TODAY study, the

PEERREVIEWED


PC and DE at each study center work together to sched-

ule and conduct visits, as well as collect outcome data.

Although the study design and roles are protocol-driven,

placing specific expectations on the PC and DE, the real-

ity of carrying out each visit requires flexibility and task-

sharing; the demands often lead to overlap in these roles at

each study site.

In order for this type of staffing model to be effectively

implemented, teamwork and cross-training are essential

and are supported by weekly conference calls and periodic

study group meetings among all PCs, DEs, and staff of

the Data Coordinating Center (DCC). The calls allow the

opportunity to offer thoughts and perspectives on current

study issues, as well as the opportunity to explore specific

questions or challenges of protocol implementation. Both

PCs and DEs attend study trainings that emphasize imple-

mentation of the trial and care of the enrolled population.

This cross-training assures that the DE or PC can each

help with the other’s tasks where necessary, in order to

facilitate timely completion of the study visits.

There are limited published reports regarding effective

staffing models of large clinical trials, and although the

typical tasks performed by a research nurse6,7 and/or clini-

cal research coordinator8,9 have been described, the roles

remain poorly defined. Little is known about workload dis-

tribution and job satisfaction, and many of the reports are

anecdotal in nature.

In the Diabetes Control and Complication Trial (DCCT),

the PC role was filled almost exclusively by nurses. Dur-

ing the planning phase of the DCCT, the anticipated scope

of duties of the research trial coordinator was unclear. In

1984, the second year of the trial, 21 trial coordinators (19

nurses, one physician’s assistant, one dietician) were sur-

veyed about their job activities, and subsequently reported

diverse duties, including spending almost 50 percent of

their time in medical management and 30 percent in ad-

ministrative activities. 10

In the 1990s, there were few resources available for in-

experienced PCs and the expectations of the role remained

vague. It was not uncommon for studies to employ a model

of hiring a PC with no clinical background, but who ex-

In the 1990s, there were few resources available for inexperienced PCs and the role remained vague.

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Sites

celled in other skills such as problem solving, communica-

tion, and organization.5 In some studies, dieticians were

selected for the PC role due to the necessity of delivering

nutrition education as part of the study protocol.11

In 2004, a survey of the standard tasks performed by 41

oncology clinical trial research coordinators showed that

they all participated in activities such as recruitment, data

collection, adverse event reporting, and audit preparation.8

Those with a nursing background had significantly greater

involvement than non-nurse coordinators in clinical care,

such as assessment of response to therapy, adverse effects,

and query resolution. In 2007, a report of survey results

from 205 PCs (50 percent registered nurses) examined

factors related to PC turnover. The findings revealed three

major themes: the need for formal training, lack of promo-

tion opportunities, and poor allocation of workload.9

In the TODAY study, a combination of clinical manage-

ment and administrative tasks are required at each study

visit. In general, the PC is primarily responsible for adminis-

trative aspects of study implementation, such as IRB corre-

spondence, budget preparation, supply ordering, equipment

maintenance, data entry, and shipping of lab specimens.

The DE’s central responsibilities focus on medication ad-

herence and adjustment, patient and family education, and

clinical management of diabetes and its comorbidities.

However, scheduled participant visits do not necessarily fall

into discrete components solely requiring the skills of one

type of staff member (clinical) or another (administrative).

In addition, many study visit appointments occur during

non-routine work hours in order to accommodate the par-

ticipants’ work and school schedules. It is neither practical

nor feasible, within the constraints of staffing limitations,

to always have both staff members available for each visit,

especially when visits occur after hours and on weekends.

To determine if the degree of overlap between the roles

of the PCs and DEs across all sites was consistent with

our expectations, given the complexity of the study visits,

a questionnaire was developed and administered to all eli-

gible PCs and DEs.

MethodsParticipants. The sample consisted of 31 TODAY staff mem-

bers (n=15 PCs; n=16 DEs). The authors, who represent

DEs and PCs, were not included in the sample to avoid bias

of the results.

Measures. The authors developed a questionnaire de-

signed to examine specific responsibilities related to con-

ducting study visits and participant follow-up. It included a

demographic section (i.e., role assignment as a PC or DE,

years of experience working on the TODAY study, years

of experience working in diabetes care/research prior to

TODAY, education level, and employment status with the

TODAY study—part-time or full-time), and an 18-item list

of the tasks expected to be most frequently performed by

PCs or DEs as described in the TODAY study manual of

operations and through author consensus.

Procedures. The survey was administered during a na-

tional study group meeting in June 2008. To preserve ano-

nymity of the respondents, the survey was distributed and

collected by a DCC representative. To be sure that all PCs

and DEs had the opportunity to participate, the DCC also

distributed the survey via e-mail following the meeting.

Responses to the electronic survey were sent directly to the

DCC, where results for all of the surveys were tallied and

categorized according to role group (PC/DE).

ResultsThirty-one responses were received out of a total possible

sample of 43 representing a response rate of 72%. Demo-

graphic information regarding the sample is summarized

in Figure 1. Most respondents (65%) held a bachelor’s de-

gree, and close to one-third had a master’s level education.

Of the 31 respondents, the majority came from a nursing

background (54%), while the remainder was evenly divided

between dietetics (22%) and other disciplines (22%). Before

working in the TODAY study, 45% had less than one year of

research experience, while 13% had greater than 10 years.

The most common previous research experiences included

roles as a research coordinator (55%), recruiter (42%), and re-

search nurse (39%). About 50% of those who responded were

working part-time on the study, while 50% reported working

full-time. Approximately half of the respondents had been

with the study since its inception and half had started after

the beginning of the trial. The majority (65%) had greater

than five years of experience in diabetes-related patient care.

PCs and DEs Background and Professional Affiliation

70%

60%

50%

40%

30%

% o

f R

esp

on

de

nts

Education

Previous

Research Experience

Previous

Roles Experience

PC

DE

20%

10%

0%

BA BSRN RD NP

MS

<1yr

1-5 yr

6-10

yr

>10yr

Resea

rch A

ssist

ant

Resea

rch C

oordin

ator

Resea

rch N

urse

Co-Inve

stig

ator

Recru

iter

Adm

inist

rato

r

Resea

rch D

itician

Source: Mary E. Larkin et al.

Figure 1. Research coordinator and recruiter

were the two most common roles among PCs and

DEs prior to joining TODAY.


Consistent with our cross-training goals, a high degree

of overlap is confirmed by the answers to the self-report

survey. As shown in Figure 2, the respondents share (de-

fined as over 50% of both PCs and DEs report performing

on a regular basis) close to half (8 out of 18) of the typical

study-related tasks, such as: scheduling visits, maintain-

ing phone correspondence, attending meetings, setting up

study visit charts, allocating medication from the central

dispensing center, assessing medication compliance, and

obtaining anthropometrics. In addition, DEs obtain lab

samples slightly more often than PCs.

Discussion Results from the current study are consistent with the

hypothesis that coordination of the TODAY study involves

cross-training and task-sharing between two roles, the

PCs and DEs, across all sites. An example of the benefits of

cross-training can be seen in scheduling appointments and

maintaining communication with the participants. These

are typically two of the most time-demanding tasks for the

PCs, as participants frequently reschedule multiple times

due to conflicting plans. In addition, because of the chal-

lenges that many study families face which include other

health issues and socioeconomic and language barriers,

Tasks Performed on a Regular Basis by PCs and DEs

% o

f R

esp

on

den

ts

Tasks

100

90

80

70

60

50

40

30

20

10

Sch

ed

ulin

g

Vis

it S

et-

up

Ph

on

e C

alls

Sta

ff M

eeti

ng

s

Main

tain

eq

uip

men

t

IRB

Co

mm

itte

e c

alls

Su

pp

ly o

rderi

ng

Ob

tain

an

thro

po

metr

ics

Bu

dg

et/

gra

nt

mg

mt

Dru

g a

llo

cati

on

Data

en

try

Sh

ipp

ing

Ass

ess

med

co

mp

lian

ce

Ob

tain

/pro

cess

lab

sam

ple

s

Med

icati

on

ad

just

men

t

Ru

n-i

n less

ion

s/fo

llo

w-u

p e

du

cati

on

PC

DE

Inte

rpre

t la

b r

esu

lts

& d

ete

rmin

ein

terv

en

tio

ns

0

Source: Mary E. Larkin et al.

Figure 2. Program coordinators and diabetes educators shared close to half of the typical study-

related tasks.

Data manager, Todashi,

processes data from an

oncology study.

10.14amTokyo, Japan.

ICON Clinical Research

24 hours in the life of ICONWhen it’s 7.14pm in our Nashville office,

it’s 10.14am in Tokyo, where a data manager

is reviewing EDC data within our integrated

reporting system and providing comprehensive

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data managers are trained to employ the most

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contact information may change frequently, making it dif-

ficult to stay in contact. During some phases of the study,

frequent contact by phone may be required between the DE

and the family, for example, when it is necessary to adjust

insulin doses and review blood sugar levels. Because of the

frequency of phone contact utilized in this activity, the DE

can also assume the administrative task of scheduling ap-

pointments, thus alleviating the burden on the PC.

Another benefit of having staff members from both groups

(PC and DE) working closely with the participants is that

different information may be reported to each individual. For

example, the PC collects general information from the par-

ticipant and/or the family during check-in. This information

is often very important and related to diabetes self-manage-

ment and may not always be shared with the DE. It is impor-

tant for the DE and the PC to communicate throughout the

visit to make sure that all relevant information gathered by

the PC is provided to the DE for review and clinical interpre-

tation. For instance, if the participant has exceeded a certain

threshold of weight gain or an elevated blood pressure prior

to the last visit, the results will be brought to the attention of

the DE so that he/she can intervene by reinforcing education

or evaluating whether a study MD should be consulted.

Study visits, which involve gathering anthropometric

data, administering questionnaires, assessing medica-

tion compliance, downloading blood glucose meters, and

providing medication and monitoring supplies, can range

from 1-7 hours in length and are often complicated by

unanticipated difficulties in schedule flow. Managing new

comorbid conditions such as hypertension, hyperlipidemia,

or poor glycemic control may necessitate unexpected time

spent for teaching insulin injections, low-fat meal planning,

or instructing the family in the use and side effects of new

medications. As a result, PCs may need to re-prioritize

the goals of the visit, allowing more time with the DE than

planned, without disrupting the schedule of data collection

or jeopardizing adherence to the protocol.

Conclusions The PCs and DEs in the TODAY study collaborate to fa-

cilitate study visits, track participant progress, and nurture

relationships with participants and their families. As de-

scribed previously, the PCs and DEs have a working knowl-

edge of each others’ roles, which fosters team cohesion,

especially during subject appointments. Task-sharing pro-

vides opportunities for preemptive problem solving among

the front-line study staff. Depending on staffing, each site

may function slightly differently, but it is essential for the

DE and the PC to work together as a team throughout the

study visit to ensure complete data collection and efficient

time management.

This staffing model provides mutual support for the PC

and DE at each study center, decreases the challenges cus-

tomarily encountered solely by the study coordinator in a

complex trial, and allows for cross-coverage and flexibility.

While the roles retain their specific responsibilities and

specialties as dictated by the study protocol and design,

there is significant overlap, redundancy, and cross-training

between the two groups, allowing flexibility of participant

scheduling and the ability to respond to unanticipated

needs of participants as they may arise.

The limitations of this staffing model include the added

resources which may be necessary to train and support

both role groups as well as the need for continued commu-

nication between staff members in order to facilitate this

level of collaboration.

This type of collaborative staffing model (where the spe-

cific job responsibilities and procedural protocol are clearly

laid out while allowing for the burden to be shared for some

of the most time-consuming and tedious elements of study

coordination) could potentially increase job satisfaction

and reduce staff turnover in long-term trials. For example,

research conducted in community mental health settings

suggests that the implementation of manualized protocols

such as those utilized to guide the implementation of the

TODAY study can enhance staff satisfaction and decrease

staff turnover.12 While this effect was not measured or

reported in this article, future research may be aimed at

describing the relationship between staffing models, staff

attrition, and subject retention.

Editors’ note: Funding information and a list of TODAY

Study Group members can be found in the online edition of

the article, www.appliedclinicaltrialsonline.com.

References 1. American Diabetes Association, “Type 2 Diabetes in Children

and Adolescents Consensus Statement,” Diabetes Care, 23 (3)

381-389 (2000).

2. A.L. Rosenbloom, J.R. Je, R.S. Young, and W.E. Winter, “Emerg-

ing Epidemic of Type 2 Diabetes in Youth,” Diabetes Care, 22 (2)

345-354 (1999).

3. G. Alberti, P. Zimmet, J. Shaw, Z. Bloomgarden, F. Kaufman,

and M. Slink, “Type 2 Diabetes and the Young: The Evolving

Epidemic,” Diabetes Care, 27 (7) 1798-1811 (2004).

4. The TODAY Study Group, “Treatment Options for Type 2 Dia-

betes in Adolescents and Youth: A Study of the Comparative

Efficacy of Metformin Alone or in Combination with Rosigli-

tazone or Lifestyle Intervention in Adolescents with Type 2 Dia-

betes,” Pediatric Diabetes, 8 (2) 74-87 (2007).

Future research may be aimed at describing the relationship between staffing models, staff attrition, and subject retention.


12. G.A. Aarons, D.H. Sommerfeld, D.B. Hecht, J.F. Silovsky, and

M.J. Chaffin, “The Impact of Evidence-Based Practice Imple

mentation and Fidelity Monitoring on Staff Turnover: Evidence

for a Protective Effect,” Journal of Consulting and Clinical Psychol-

ogy, 77 (2) 270-280 (2009).

Mary E. Larkin** MS, RN, CDE, is the Manager of Clinical

Research and Chair of the TODAY Study Diabetes Educator

Committee, e-mail: [email protected], Karen Blumenthal,

BA, is a Research Assistant, and Denise Richards, MSN, FNP,

CDE, is a Nurse Practitioner and Diabetes Educator, at the

Massachusetts General Hospital Diabetes Center 50 Staniford

Street, Ste. 340, Boston, MA 02114. Paul McGuigan, BSN,

RN, CDE, is the Program Coordinator at Rainbow Babies and

Children’s Hospital CASE Medical Center. Kerry Milaszewski,

BSN, RN, CDE, is a Diabetes Educator and Laurie Higgins,

MS, RD, LDN, CDE, is a Diabetes Educator at Joslin Clinic,

Boston, MA. Jill Schanuel, M.Ed, is the Program Coordinator

at University of Oklahoma Health Sciences Center. Christen

Long, BA, is a Senior Research Assistant at George

Washington University Biostatistics Center.

* For the TODAY Study Group.

** To whom all correspondence should be addressed.

5. S. Pelke and D. Easa, “The Role of the Clinical Research Coordi-

nator in Multicenter Clinical Trials,” Journal of Obstetric, Gyne-

cologic, and Neonatal Nursing, 26 (3) 279-285 (1997).

6. M. Offenhartz, K. McClary, and C. Hastings, “Nursing and New

Realities of Clinical Research,” Nursing Management, 39 (11)

34-39 (2008).

7. H. Ehrenberger and L. Lillington, “Development of a Measure

to Delineate the Clinical Trials Nursing Role,” Oncology Nursing

Forum, 31 (3) 64-68 (2004).

8. F. Rico-Villademoros, T. Hernando, J. Sanz, A. Lopez-Alonso, O.

Salamanca, C. Camps, and R. Rosell, “The Role of the Clinical

Research Coordinator-Data-Manager-in Oncology Clinical Tri-

als,” BMC Medical Research Methodology, 4 (6) 2004.

9. C. Duane, M.A. Granda, D. Munz, and J.C. Cannon, “Study

Coordinators’ Perceptions of their Work Experiences,” The

Monitor, September 2007, 39-42.

10. J. Ahern, N. Grove, T. Strand, J. Wesche, C. Seibert, A.

Brenneman, and W. Tamborlane, “The Impact of the Trial

Coordinator in the Diabetes Control and Complications Trial

(DCCT),” The Diabetes Educator, 19 (6) 509-512 (1993).

11. A. Frydrych, J. Burrowes, J. Leung, S. McLeroy, D. Cock-

ram, L. Uhlin, S. Marjoram, B. Weiss, and J. Dwyer, “Dieti-

cians as Study Coordinators,” Applied Clinical Trials, March

2003, 60 -68.

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Project Director, Daniel, ensures that

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eCRF are ready for review by a

cardiologist for a type 2 diabetes trial.

3.28pmZurich, Switzerland.

When it’s 9.28am in Philadelphia, it’s 3.28pm in

our medical imaging core laboratory in Zurich,

where medical images, lab summaries, ECGs,

patient profiles and the eCRF are electronically

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Workload

Measurement

Instrument

It is necessary to understand the time, staff, and financial resources required to conduct clinical trials.

Mary Coffey, Julie Berridge, James Lyddiard, and Jacqueline Briggs

CHAD BAKER/GETTY IMAGES

It is increasingly evident to all par-

ties involved in the sponsorship and

management of clinical trials that

a better understanding of the time,

staff, and f inancial resources re-

quired to conduct clinical trials is neces-

sary. The increasing use and complexity

of multi-modality treatment regimes, the rising

costs of clinical trials, the emphasis on the ef-

ficient use of available resources and adherence

to Good Clinical Practice (GCP), and increas-

ing regulatory requirements and demands for

quality assurance/control, have resulted in an

increased focus on workload issues. Failure to

address these issues has resulted in research

staff using unproven methods or a simple esti-

mation for determining workload, leading, in

some cases, to unrealistic expectations, exces-

sive workload, or inefficient use of resources.

The EORTC Clinical Research Coordinators

Group recognized the importance of address-

ing this problem based on understanding the

tasks involved, the time requirements, and the

resources necessary to effectively and efficiently

conduct clinical research. The development of a

workload measurement instrument (WMI) was

seen as a means of providing a tool by which

individuals could estimate more accurately the

time and resources required to participate in

clinical trials. The initial project was supported

by the EORTC and funded by a grant from Fonds

Cancer (FOCA).

The WMI was developed in seven

stages and the first stages: development,

validation and revision of a draft check-

list of trial related activities, drafting of

the WMI, a feasibility pilot study, and

analysis and revision of the trial related

tasks incorporated into the four modules

previously outlined in an Applied Clinical

Trials article that appeared in June 2008,

titled “Workload Measurement.”1 Coincidental to

the development of the WMI, Jacqueline Briggs

had developed a complexity tool for assessing

the complexity of a study prospectively.2 It was

agreed that, in the longer term, a joint workload

and complexity project would aim to indepen-

dently validate and link together the WMI and

the complexity tools.

This article describes the seventh stage of

development of the WMI; a prospective study

using the WMI to collect data for the purpose of

validating the four WMI modules.

Materials and methodsThe preparatory phase identified the specific

actions necessary and the financial and staff

resources required to complete the prospective

study. The Steering Committee members pre-

sented the prospective study outline to a meet-

PEERREVIEWED


ing of National Cancer Research Network Managers and

identified the networks that would be willing to collaborate.

Expression of interest questionnaires were sent out to all

UK network managers and to research staff in several Eu-

ropean centers to identify research staff and potential trials

for inclusion in the prospective study. Fifteen UK networks

and a center in Ireland initially agreed to participate in the

study and, of these, 12 networks returned completed mod-

ules as part of the prospective study.

The prospective study focused only on research related

activity and not on what would be considered routine care.

Workload was only recorded for research staff working on

the trials and excluded investigators, pharmacists, day care

staff, etc. These staff members were excluded as it was felt

that it would be difficult to collect accurate workload data

from such a wide range of staff and this was accepted as a

limitation for the purposes of this study.

As the joint project had been extended to include

complexity the four WMI modules (Module 1: planning

stage; Module 2: implementation stage; Module 3: trial

data management stage; Module 4: closure/final stage)

were reviewed. In order to facilitate the validation of the

complexity tool and create the necessary links between

the two tools, it was agreed to divide Module 2 into two

modules: 2a recruitment and treatment and 2b treatment

and follow-up.

A data collection period of six months was agreed and

the time frame for completion of data collection was Oc-

tober 2005 to May 2006. Prior to the commencement of

the data collection period, three training days were held

in Newcastle, London, Nottingham, and Wales to roll

out the study to the interested participants. Forty-three

Modules Returned

Module Title

Number

returned

1 Planning 17

2a Implementation—treatment 268

2b Implementation—follow-up 88

3 Trial data management 41

4 Closure/final 0

Source: Mary Coffey et al.

Table 1. A total of 414 completed modules were returned from collaborators from 27 hospitals covering 12 UK Cancer Research Networks.

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Tianjin, China.

When it’s 8.45am at our central laboratory in

Dublin, it’s 4.45pm at our central laboratory

in Tianjin, where chemistry samples for a

cardiovascular study are being tested. This

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research staff attended these training days. Information

was provided individually for staff unable to attend the

training days.

From the training days and returned questionnaires, a

number of trials were selected on which the prospective

study would focus. For modules 1 and 4 it was agreed that

any trial in set up or at the closure stage could be included

due to the small number of trials likely to be at these

phases during the six month time frame. For modules

2 and 3, trials covering as many tumor types, treatment

modalities, and study types were selected to ensure as in-

clusive a range of activities as possible. A total of 36 studies

were identified and included in the prospective study.

Guidelines for the completion of each module were de-

veloped and circulated, together with the four modules and

the list of identified trials, to 70 collaborators, covering 15

networks that had agreed to participate. Collaborators were

asked to record the time taken, in minutes, for each indi-

vidual task or subtask undertaken as identified within the

modules. A subsection—other—was included for recording

any additional activities not identified within the modules.

A separate section recorded the hospital name, trial name

and number, the date for data collection commencement

and completion, the reason why data collection was ended,

and whether more than one form had been completed. This

allowed us to identify the total period

of data collection and subsequent anal-

ysis of workload for a single trial visit

or over the course of a trial period.

Data was entered into a database

developed in conjunction with the

NCRN IT department based on all the

identified tasks and subtasks of the

WMI modules. The NCRN agreed to

provide staff in order to complete the

data input and carry out some pre-

liminary data analysis and a system

for quality assurance of the data was

agreed upon.

The Steering Group met regularly

to review the progress of the prospec-

tive study, and as returned modules

were received, to carry out the initial

quality assurance procedures. All re-

turned modules were double-checked

to ensure accuracy, and when tasks

or subtasks were entered in an in-

correct section these were noted and

revised prior to entry onto the da-

tabase. Incorrect or unclear entries

were deleted. Regular contact and

feedback was maintained with the

collaborators throughout the study

by e-mail, newsletters including answers to frequently

asked questions, and presentations at Cancer Research

Network Managers’ meetings.

ResultsA total of 414 completed modules were returned from col-

laborators from 27 hospitals covering 12 UK Cancer Re-

search Networks. Three networks or centers did not return

Summary of the Changes Made

Number of subtasks

on which changes

were made

Number of times a

change was made to

the same subtask

57 1

11 2

2 3

1 5

1 9

1 15

1 16


Table 2. Cumulatively, 130 changes were made.

Subtask Completion per Module

Number of times

a subtask was

completed

Modules

1 2a 2b 3

> 10 10 2 4 11

11-20 3 3 2

21-30 3 2 1 1

31-40 4 1

41-50 4 3 1

51-60 4

61-70 2 2 2 1

71-80 3

81-90 3 1

91-100 1

101-200 14 1

200+ 16 1 1


Table 3. For Module 2b and 3, the most frequently completed subtasks related to case report form completion, photocopying and sending trial documents, and the preparation and submission of trial amendments.

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completed modules due to merger of networks, shortage of

staff, or excessive workload issues. Data was returned on

35 of the 36 studies identified for inclusion in the prospec-

tive study. Table 1 shows the modules returned.

As part of the analysis process a series of assumptions

were made. These included: research staff were experi-

enced and trained and not involved in the actual delivery

of treatment, research activity was additional to standard

treatment, and hospital support services and standard

equipment were available and accessible to research staff.

Cumulatively, 130 changes were made in the 74 sub-

tasks (Table 2). These changes included transfer from one

subtask to another where an entry was incorrect, deleting

investigators, and separating out multiple patient visits into

individual visits. The highest numbers of recording errors

(9, 15, and 16) necessitating transfer related to the record-

ing of administration activities in other subtasks rather

than administration activities.

Following extensive quality assurance procedures all

tasks and subtasks within Modules 1, 2, and 3 were vali-

dated as relevant and appropriate with no tasks or subtasks

removed. All subtasks were recorded at least once with a

very wide range within each module. For Module 1, the

most frequently completed subtasks were those relating to

the preparation and submission of documentation to Ethics

and Research and Development departments. Conversely

the lowest recorded tasks related to organizing and attend-

ing meetings other than in-house meetings for information,

training, and trial activation.

For Module 2a, the most frequently completed subtasks

related to screening for eligibility, informed consent, and

sample preparation. This was consistent with the expecta-

tions and personal experience of the project group. The

least completed subtasks in Module 2a related to liaising

and verifying radiotherapy dose reductions and missed

treatment which was anticipated given the very low num-

bers of radiotherapy related trials included in the study.

For Module 2b and 3, the most frequently completed sub-

tasks related to case report form completion, photocopying

and sending trial documents, the preparation and submis-

sion of trial amendments, and updating study documents

following amendments (Table 3).

Two major revisions were identified as necessary. The

first change related to the recognition of the importance

given to administration and communication by the collabo-

rators. The section “other” consistently included additional

administration and communication and it was agreed that

these two activities should be included as subtasks for all

main tasks in the final modules. In total, 110 transfers were

made to administration main tasks and 230 to administra-

tion subtask activities; 38 to communications main task,

with 100 to communication subtask activities. The second

change was the recombination of Module 2a and 2b with

specific sections relating to consent, treatment, and follow-

up incorporated—confusion had arisen in completion of

these as two separate modules.

RecommendationsModules 1, 2, and 3 of the workload measurement instru-

ment have been validated and are now complete. These

modules are available in their entirety online in PDF format

at appliedclinicaltrialsonline.com as part of the online ver-

sion of this article. Module 4 has been revised in accor-

dance but would benefit from validation as part of a specific

prospective study as trials reach closure stage.

It is acknowledged that there were limitations to the

prospective study that included the short data collection

window of six months, the exclusion of principal investiga-

tors and other associated staff from the data collection

exercise, compounded by the difficulty associated with

specific local hospital issues all had potential to confound

the data collected. It was accepted that these factors would

contribute to workload but would not necessarily alter the

tasks and subtasks identified for inclusion in the modules

and, therefore, such confounders were not considered sig-

nificant for the purpose of the WMI validation. For hospi-

tals or departments undertaking a workload analysis in the

future it would be appropriate to take these confounders

into account.

This WMI was developed to be a generic tool and can be

used locally, nationally, or internationally to review the trial

workload of an individual researcher, team, hospital, or

network of centers. It should inform discussions at all levels

and allow centers considering implementing new or ad-

ditional clinical trials to accurately evaluate the associated

workload and to allocate staff and resources accordingly.

References1. Julie Berridge and Mary Coffey, “Workload Measurement,”

Applied Clinical Trials, June 2008, 98-101.

2. Jacqueline Briggs, “Real World Workload Needs: Developing a

process and management tool for scoring complexity in cancer

clinical trials,” Applied Clinical Trials: Oncology & Clinical Trials

in the 21st Century, supplement, May 2008, 22-24.

Mary Coffey* is Head of Discipline at Division of

Radiation Therapy, School of Medicine, Trinity Centre for

Health Science, St. James’ Hospital, Dublin 8, Ireland,

e-mail: [email protected]. Julie Berridge is Clinical Trials

Team Manager at Mid Trent Cancer Research Network,

Nottingham City Hospital, United Kingdom. James Lyddiard

is Head of Cancer Trials at University College London

Hospitals, NHS Foundation Trust. Jacqueline Briggs is Stroke

Research Network Manager at Peninsula Stroke Research

Network, Royal Devon and Exeter Foundation NHS Trust,

Exeter, United Kingdom.

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Increase African American Enrollment

Recession and acquisitions make recruiting America’s second-largest minority even harder.

Patricia R. Sanders

ANDERSEN ROSS/GETTY IMAGES

Recruitment of African Ameri-

cans into clinical tråials is go-

ing through another evolution.

With global patient outreach

far from peaking, the unchar-

tered growth of outsourcing overseas for

patient recruitment is beginning to raise

genetic issues at home.1 As American pharma-

ceutical and biotech companies rapidly expand

to other parts of the world, recession and acquisi-

tions compromise efforts to recruit hard-to-reach

American minority patients for clinical trials.

African Americans make up the second larg-

est minority group in the United States—in-

creased by 13 percent between 2005 and 2006.

More than 45 percent of America’s population is

non-white or classified non-Caucasian. In some

states, African Americans can make up as much

as 30 percent to 60 percent of the residents.2

Yet, too many clinical study results, related to

diseases critical to African Americans, show as

few as 2 percent recruitment of African Ameri-

cans, or vaguely stated as 9 percent “other” or

“non Caucasian.”

Illnesses such as asthma, diabetes, hyperten-

sion, HIV-AIDS, and certain kinds of cancer af-

fect African Americans more than other people.

Little is known about the ways African Ameri-

cans respond to treatment for these and other

conditions. Despite government regulations that

require minorities to be included in federally

funded research projects, African Americans re-

main underrepresented in these critical projects.3

Most clinical research sponsors are

aware of this shortfall, and admit there

is a problem. Yet many don’t specify or

request even 10 percent to 15 percent of

African Americans in studies unless there

is a special protocol, or unless it relates to

HIV-AIDS, sickle cell anemia, and certain

cancers. Setting minimum requirements

with your team is the first step in the complex

chain to reach African American participants.

With the 2010 US Census expected to assert-

ively focus on hard-to-reach minorities and un-

derserved populations,4 the results are predicted

to reveal even higher numbers of minorities than

in the past. If so, the omission of mandatory

clinical recruitment policies regarding African

Americans and minorities will be somewhat like

playing Russian roulette with an entire popula-

tion. Though efforts such as EDICT5 (Eliminat-

ing Disparities in Clinical Trials) has begun to

recommend new policies, changing the present

scenario requires due-diligence and creative

partnerships, both within and outside of this

clinical trial and cultural void.

In a recent health disparities symposium on

cancer, David Satcher, MD, PhD, Director of

the Satcher Health Leadership Institute, More-

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house School of Medicine in Atlanta, GA, spoke on “A

Right to Care.” He outlined significant barriers to health-

care of African Americans in the United States that he

calls the “UNs:” uninsured, underinsured, underserved,

and underrepresented.5

Satcher stated that 40 million Americans are uninsured;

25 million underinsured. “Doctors tend to clump together

where it’s comfortable and usually it’s not near the under-

served,” he said.

“Over the past 10 years, black doctors (and nurses) are

underrepresented in our healthcare system, and we are not

making significant progress in that area.” When seeking

healthcare or in clinical trials, it is important that a person

see themselves represented in the healthcare system.

Minority educationEliminating racial disparities in clinical trials begins and

ends at the top, with education. Educating the doctors and

medical providers is a start, but it ’s

not enough. It is critical to begin the

educational process with sponsors of

clinical trials. They could set the bar

higher by first requesting, and then

requiring larger numbers of African

Americans pre-screened for all trials

for diseases critical to this population.

The problem with recruiting and

retaining African Americans in clini-

cal trials should be viewed as the

“problem with us”—those respon-

sible for clinical recruitment, rather

than the “problem with them.” Find-

ing solutions should be a multi-level,

multi-tasking function of the sponsor;

recruitment team; clinical research or-

ganization’s or patient research orga-

nization’s vendors; project managers;

and local site investigators, all working

in concert toward this goal.

With new drug discoveries in the

pipeline, many offering hope for Af-

rican Americans,6 recruit ing them

requires new strategies that provide

ground-zero opportunities across the

board, and with the highest ROI—one

that will bridge cultural gaps.

Outreach strategies The investment return for expanding

minority outreach can dramatically

increase if that expansion includes

strategies for a closer, personal, and

more trusted outreach to venues such

as black churches and community health partnerships.

This outreach could logically make the difference be-

tween 2 percent or 10 percent recruitment of minorities in

that community.

If sponsors of trials want to build and sustain trust for

future trials, they should tap into community health net-

works that already provide local health education about

diseases. Look into trial outreach through black profes-

sional newsletters, flyer distribution to partnered church

health initiatives, and community organizations. Use site

investigators as resources. This will make a trial more

important to the community than other trials trying to re-

cruit from a distance.

Sometimes, for example, local site investigators are

already involved with these organizations. A community-

involved site investigator means there is already an impor-

tant trust factor present. Something as simple as a brief site

investigator survey could produce a treasure of resources.

C.E.D.R.I.C.T Quick Facts

C.E.D.R.I.C.T. (pronounced ced’rick) (Coalition to Eliminate Disparities and to Research

Inclusion in Clinical Trials) is a national, three-year pilot field research study on how to

increase clinical participation and retention through the education of African Americans

in clinical and medical trials.

C.E.D.R.I.C.T., a National Physician and Family Referral (NPFR) Project, began in June

2009, collaborating with National Black Leadership Initiative on Cancer (NBLIC III),

Morehouse School of Medicine, Center for Information and Study of Clinical Research

Participation (CISCRP), National Medical Association (NMA) Project IMPACT , and

National Human Genome Center at Howard University.

Through this field research study, a model for African Americans in Clinical Trials

(AACT)—pronounced ACT—a coalition pilot will be developed in key cities. The

intervention will serve as a community model for ongoing recruitment and retention of

African American and minority participants.

C.E.D.R.I.C.T. will reach over 10 million African Americans and survey over 20,000 during

the three-year period. The field research will both validate and define previous data

about fears or apprehensions about participating in medical research. It will also bring

new data on ways to eliminate the health disparities of African Americans in clinical trials.

The potential impact: C.E.D.R.I.C.T. responds to the missing pieces of the puzzle

that identifies barriers, as seen by African Americans themselves, and creates access

to networks of coalitions to assist them in becoming more educated about clinical

trials. With access to these coalitions, disease therapy education and clinical research

recruitment becomes easier as it expands into target populations.

C.E.D.R.I.C.T. is not a scientific, academic or medical research. It is conducted by

nonprofit companies with years of successful work in patient education, clinical trials

outreach, and recruitment of African Americans; utilizing dozens of community-based

and medical networks around the country.

Source: Patricia R. Sanders

Table 1. C.E.D.R.I.C.T. evolved to gather face-to-face data on African

Americans nationally.


Sites

Where site investigators are involved in the commu-

nity, there will be a greater access to African American

patients. Likewise, patient recruitment of this population

could increase dramatically in key states7 if project man-

agement is focused upon identifying, training, and funding

African American physician investigators already involved

in the community.

A new ground-zero field research, called C.E.D.R.I.C.T.,

pronounced CED’ rick, [Table 1] (Coalition to Eliminate

Disparities and to Research Inclusion in Clinical Tri-

als) has evolved to gather face-to-face data on African

Americans nationally. The initial surveys observed three

obstacles that must be tackled for better patient recruit-

ment. It also has observed three keys to addressing these

obstacles. The obstacles are trust, interest, and opt-in op-

portunities. The keys are disease, patient, and community

education.

Developing an outreach to recruit minorities for clinical

trials, while at the same time creating trust often relies on

media data that does not provide a true picture of potential

African American clinical trials participants. So we take

the standard shortcut when looking for minorities: Adver-

tise in black media.

Advertising is a proven outreach strategy and it works

on many fronts. However, the obstacle of trust cannot be

overcome solely by talking to African Americans about a

clinical trial between R&B songs. Trust involves an “in-

your-face” approach to such an intimate undertaking as

participating in a clinical trial. And for many minorities this

is not an option.8

Elise D. Cook, MD, Chair, Minority and Medically Un-

derserved Subcommittee, for SELECT trials9 was part of

the team that developed focus groups to get input from

men in target population(s). During the study, ways to

enhance minority recruitment were explored and three

one-day minority recruitment workshops were developed,

along with community partnerships with NBLIC II and

others [see sidebars]. They found that trust was built

among participants where open and ongoing communica-

tions evolved, and continued with participants even after

the trials ended.

Developing ethnic-focused communication toolsTools for developing ethnic-focused, community-based

project management could be as simple as creating a selec-

tion of educational trials flyers, posters, brochures, or pam-

phlets for distribution by your “community-involved” site

investigators in their communities.

Familiar, face-to-face exchange and distribution of cul-

turally-sensitive information, both in doctor’s offices and

the community, presents huge recruitment opportunities

toward establishing trust among African Americans for

multiple diseases.

Support project management by providing what is known

as an 800 ERN (Educational Referral Number) to buttress

the unfamiliar pre-screening interview. The ERN allows

participants to ask questions and allows for smoother tran-

sition into pre-screening. Utilizing an 800 ERN throughout

the recruitment campaign could be a positive, escalating

educational tool.

Appropriate city and site selection is critical. Unfortu-

nately, it’s often easier and quicker to stick with the famil-

iar sites. If you are looking to recruit African Americans,

selecting a site in the suburbs, as opposed to one with a

heavy concentration of African Americans, can present

Focus Groups

■ Input from men in the target population

■ 78 men participated: 16 African American and 32

from the Veteran’s Administration Hospitals system

■ Recommendations regarding communications

– Highlight personal incentives

– Explain why the study supplements were chosen

– Provide frequent study updates

– Include family members, especially spouses

– Special strategies for recruitment of minority,

low literacy, low income, and medically under-

served men

Partnership with NBLIC II

■ Minority outreach initiative of the NCI

■ Innovative outreach strategies partnering with the

local SELECT sites

– For Men Only retreats, Wellness on Wheels, and

Taking it to the Top,

■ Promotional items for events

– T-shirts, squeeze water bottles, and caps with the

SELECT logo

Minority Recruitment Workshops

■ Three 1-day workshops

– Round table discussions

• Share strategies, develop mentoring relation-

ships, and discuss problems

– Panel discussions with local community leaders

and SELECT Investigators

• Share recruitment ideas

– Disseminated workshop proceedings to all SELECT

staff at the semi-annual SWOG/SELECT Workshops

20

To Register for the 2011 program and place your nomination

for the Hall of Fame Awards, visit us online at

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NOMINATION CATEGORIES

Announcing the

1st Annual Partnerships Hall of Fame Awards

Partnerships in Clinical Trials event will host it’s


ceremony to honor and celebrate the Partnerships

MVPs throughout the past 20 years.

Technology and Innovation

Lifetime Achievement

Operational Excellence

Change Management

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Sites

obstacles for participation. Finding sites that are within a

comfortable distance from African American communities

could be a matter of finding African American site doctors

and then helping them to outreach for your trial.

Sponsors could increase their chances for successful

minority recruitment by making mandatory a percentage

of investigators who are both African American doctors as

well as non-minority physicians in areas with large African

American patient bases. Applied Clinical Trials’ Editor-in-

Chief Lisa Henderson, aptly noted in May 2008 that “trial

availability in that community; physician participation in

the trial; and finally, being able to meet the criteria,” were

elements in successful recruitment of African Americans

in an oncology trial.10

Sparking interest is an elusive obstacle that is best fa-

cilitated through site community partnerships. The ques-

tion arises, “If 30% to 70% of (minority subjects) say they’d

be willing to be in a clinical trial...why do so few actually

enroll?”11 Of the African Americans surveyed, over 40%

stand firm on willingness to participate in clinical trials if

someone asked them. However, 92% are firm about their

willingness to participate if they had more information

(education) before they are called to pre-screen. Clearly,

this is an important key.

Creating an interest in clinical trials participation among

African Americans requires face-to-face exchange for

maximum effectiveness. It then becomes the question of

how to develop techniques that impact African Americans

targeted for inclusion. The residual benefits of shifting a

small percentage of the site project management resources

to a community ethnic-focused campaign will translate to

a greater ROI on current and future trials. As FDA guide-

lines become more inclusive, this shift will also avoid wast-

ing time and money backtracking later in order to recoup

minority participants for final drug approval.

With the new Health Insurance Portability and Account-

ability Act (HIPPA) regulations, outreaching to gain minor-

ity interest in clinical trials without perks and incentives

requires building strong community partnerships. Often

this is done directly at the project management and site

investigator levels.

The most profitable investmentThe third obstacle, creating opt-in opportunities, directly

impacts patient recruitment vendors and site investiga-

tors. Inf luencing African Americans to opt-in to a da-

tabase or referral list for trial participation can be site-

based, event-based, web-based, or via sponsor’s patient

recruitment vendors.

When trial sponsors outsource to clinical and patient re-

cruitment organizations, they are hoping these vendors are

able to pull their trials across the invisible line of “minimum

requirements” for African Americans and minorities. For

some trials (and a few diseases), this happens. Taking re-

sponsibility for minority patient recruitment at the beginning

helps sponsors and project management teams take control.

Clinical trial participant databases identif ied as ex-

clusively African Americans are rare. However, one re-

cent educational outreach that evolved from the 2009

C.E.D.R.I.C.T. field research is, “African American Health

Matters.” African American Health Matters is an opt-in

mobile health text message program that sends health re-

minders and tips to over 25,000 subscribers about selected

health matters. Fifty-eight percent of this audience is not

on the Internet, but 84 percent have cell phones.

Text messages also offer toll-free numbers and websites

to find disease educational materials, clinical trials remind-

ers, and positive reinforcement messages designed to help

participants maintain a positive mental attitude, an impor-

tant element of good health.

Planned involvementSponsors and recruitment organizations should adhere

to quality checks of their minority patients and physician

databases. Vendors should keep updated information about

targeted African American participants and doctors for

referral to trials. Look at track records. Whether perfor-

mance-based plus community advocacy or advertisement-

based recruitment, the yardstick for a vendor’s ability to

recruit for multiple racial populations is database develop-

ment of specialized audiences.

Sponsors should require “minimum goals” for recruit-

ing African Americans in all US-based trials. The national

average population of African Americans is around 12%,

and over 100 cities have more than 30%. With these num-

bers, recruiters should consider requiring at least 10%

participation for diseases with high mortality rates in this

population. This requirement will present new recruitment

opportunities and offer increased education for critical dis-

eases such as diabetes, hypertension, cholesterol, asthma,

arthritis, obesity, and tobacco use.

In C.E.D.R.I.C.T.’s initial field surveys, other diseases

were found to be of interest: orthopedic, cardiovascular,

prostate related, breast, lung and colon cancers, gastric,

menopausal, post menopausal, addiction, and depression

trials. The point is to reach out initially with multiple dis-

eases in multiple cities in order to identify your new patient

populations. You’ll then find the community hierarchy that

offers access for future trials.

Creating interest in clinical trial participation among African Americans requires face-to-face exchange.

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From the U.S. to the UK, we’ve got you covered!


Sites

Disease, patient, and community educationThe obstacles are not insurmountable to recruiting Afri-

can Americans into clinical trials. However, the obstacles

must be overcome to avoid playing Russian roulette with

this population. How? By initiating proven market strate-

gies that work on many levels. When a company is willing

to give minority recruitment more than a cursory glance,

there are keys that will help them move forward:

Key one. Start with disease education related to the trial.

African American churches with health ministries score

big points for trust and openness. For a trial targeted to

grass-roots participation, a study flyer with trial and dis-

ease facts, and ERN numbers for pre-screening consulta-

tion is extremely valuable information at African American

churches or local health fairs.

Key two. Follow up with more patient education about

the clinical trial being conducted. This can be done with

various clinical trials recruitment outreach tools such as

trial information on black websites and community media

that cater to African American audiences, phone surveys,

web, or e-mail announcements and mobile messaging. Paid

advertisements can support this effort, but should never be

used as the primary recruitment mechanism. Also, recog-

nize the many community levels for event ads and outreach.

Key three. Keep your community network open and ac-

tive. Once you’ve established a community partnership

within selected African American communities, follow

through with each disease trial. Success depends not just

on the clinical trial, but also upon your community relation-

ship. From the relationship comes trust; from trust comes

word-of-mouth, which equals interest. From the right selec-

tion of sites and site investigators comes a cost-efficient, fo-

cused outreach support that the sponsor or patient recruit-

ment vendor can provide its sites.

ConclusionIn summary, recruiting African Americans into clinical

trials is not rocket science. However, it takes focus, commit-

ment, and a plan to develop your minority outreach around

your existing site resources by:

• Outlining ways to include African Americans, look for

strategies for inclusion and retention in your key cit-

ies by site project managers and patient recruitment

organizations.

• Developing the networks you may already have in place

in the communities with people who “talk their lan-

guage,” and with an outreach that focuses upon disease

education and health support resources.

• Supporting ground-zero opportunities in your site com-

munities with custom, IRB approved trial information

and disease education materials. Most importantly, en-

courage site outreach programs and offer bonuses and

incentives for qualifying African American doctors and

for outreach to new participants.

References 1. Tom Watkins, “Growth of Clinical Trial Outsourcing Raises

Issues,” CNN Health.com, February 18, 2009.

2. United States Census, 2000.

3. Center for Information and Study on Clinical Research Partici-

pants (CISCRP), Participant Newsletter, February 2008.

4. Associated Press, March 23, 2009.

5. David Satcher, “A Right to Care” (speech, Health Disparities Sym-

posium on Cancer: Addressing the Issues, September 21, 2009).

6. “Medicines in Development for Major Diseases Affecting Afri-

can Americans,” APC Report, 2007.

7. United States Census, 2000.

8. NPFR and C.E.D.R.I.C.T. Field Research 2010, http://www.

npfrproject.org.

9. Elise D. Cook, “Recruiting African American Men to a Cancer

Prevention Trial” (lecture, University of Texas, June 15, 2009)

10. Lisa Henderson, “Trials Where they Make Sense,” Applied

Clinical Trials Online, May 1, 2008, http://appliedclinical-

trialsonline.f indpharma.com/appliedclinicaltrials/News/

Trials -Where-They-Make-Sense/ArticleStandard/Article/

detail/513696.

11. Mark Hochhauser, “Self Deception Syndrome,” Applied

Clinical Trials Online, Nov 1, 2004, http://appliedclini-

ca lt r ia lsonl ine. f indpharma .com/appl iedcl in ica lt r ia ls/

Patient%2fSubject+Recruitment/The-Self-Deception-Syn-

drome/ArticleStandard/Article/detail/131504

Patricia R. Sanders, APR, Senior Consultant, P&E Associates,

14902 Preston Road, #404-744, Dallas, TX, 75254 e-mail:

[email protected].

Recruiting African Americans into clinical trials takes focus, commitment, and a plan to develop minority outreach.


Community

BUSINESS AND PEOPLE UPDATE People ◗ Biomedical Research Al-

liance of New York (New

York, NY) has made sev-

eral new hires including

Carmela Houston-Henry

as Business Development

Director and Rich Green as

Central IRB Business De-

velopment Director.

◗ Pamela Pannier has joined

Clinical Trials of America (Eu-

gene, OR) as Clinical Opera-

tions Director and Donald

Dickerson has joined as the

company’s new President.

◗ With over 20 years of

sales, marketing, and busi-

ness development experi-

ence within the pharmaceu-

tical arena, Rick Coulon has

been appointed Director of

Business Development at

PharmOptima (Portage, MI).

◗ Previously Chief Operat-

ing Officer of Clinigene, A.

S. Arvind, MD, has been ap-

pointed as Strategic Advisor

of Ecron Acunova (Banga-

lore, India).

◗ Making several additions

to its team, AAIPharma

Services (Wilmington, NC)

has appointed Tim Martin as

Executive Vice President of

Sales and Marketing, and

Rob Goshert as Vice Presi-

dent of Corporate Accounts.

◗ To streamline the recruit-

ment “pull-through” process

and help study sites and

sponsors succeed with their

patient recruitment efforts,

MediciGlobal (Philadelphia,

PA) has opened the Study

Resource Center and hired

Pat Patterson as its Director.

◗ Pharma Tech Industries

(Royston, GA) has ap-

pointed Bryan J. Cox as

Staff Engineer.

◗ James W. Lovett, General

Counsel of Covance, has

been appointed to BioCli-

nica’s (Newtown, PA) Board

of Directors.

◗ Edward Masterson has

joined Alliance Life Sciences

Consulting Group (Bridge-

water, NJ) as Senior Vice

President of Consulting

Operations where he will

oversee all aspects of

ALSCG consulting ser-

vices, including solution

development and service

delivery to clients.

◗ Bringing with her over

18 years of strategy experi-

ence, Rosemarie Truman

has been hired as Advanced

Clinical‘s (Deerfield, IL)

Executive Vice President

of Solutions.

◗ The Society for Clinical

Data Management (Mil-

waukee, WI) has appointed

Nimita Limaye and Ludo

Reynders, PhD, as Chairs for

its Board of Trustees.

◗ CTI Clinical Trial and

Consulting Services

(Cincinnati, OH) has made

several changes to its

team. Meredith Boley and

Robert McRae have joined

as Research Associates

and Bill Aronstein has

been promoted to Senior

Medical Director.

◗ Ricerca Biosciences (Con-

cord, OH) has appointed

William DeMaio, PhD, as

Senior Director of the Drug

Metabolism and Pharma-

cokinetics Department and

has appointed Douglas K.

Fuhrer, PhD, as Senior Di-

rector of Drug Safety.

◗ Ludo Reynders, PhD,

has joined the team at

Premier Research Group

(Philadelphia, PA) as Chief

Executive Officer.

◗ ClinPharm Consulting (Re-

search Triangle Park, NC)

has hired Giulia Ghibellini,

PhD, to implement a new

population pharmacokinet-

ics service.

◗ David Evans, Chief Infor-

mation Officer at Octagon

Research Solutions (Wayne,

PA) was appointed as

Chair to the CDISC Ad-

visory Board and Monica

Garrett, Vice President,

Global Marketing, Octa-

gon, was elected to the

position of North America

Representative on the

Board of Directors.

Alliances• Covance (Princeton, NJ)

has signed definitive agree-

ments with sanofi-aventis

(Paris, France) for Covance

to become sanofi-aventis’

R&D partner.

• Covance (Princeton, NJ)

and INphoton (Indianapolis,

IN) have entered into an alli-

ance that will grant Covance

exclusive global access to

INphoton’s intravital micros-

copy imaging technology

and expertise.

• BioClinica (Newtown, PA)

has signed a three-year,

multi-million dollar agree-

ment for enterprise-wide

EDC technology and data

management services with a

top 10 pharmaceutical com-

pany in which BioClinica

Express will support nearly

200 studies annually for this

organization.

• Cato Research (Durham,

NC) has selected Bio-

Clinica’s (Newtown, PA)

clinical trial management

system platform to help

A.S. Arvind, MDRick CoulonPamela PannierCarmela Houston-Henry


Community

streamline workflow and

facilitate the clinical study

processes.

• Richmond Pharmacology

(London, UK), Community

Research (Cincinnati, OH),

and Fundación de Investig-

ación de Diego Puerto Rico

(San Juan, Puerto Rico)

have selected Logos Tech-

nologies’ (London, UK)

ALPHADAS’ early phase, e-

source data capture system,

and site automation soft-

ware suite to accelerate and

streamline their clinical trial

operations and services.

• Charles River Laboratories

International (Wilmington,

MA) has entered into an

exclusive, long-term mar-

keting and distribution

agreement with Transposa-

gen Biopharmaceuticals

(Lexington, KY).

• PPD (Wilmington, NC)

has established an agree-

ment with the Himalayan

Institute and Hospital Trust

(Uttarakhand, India) to

expand its network of inves-

tigators in the region.


and VirtualScopics (Roch-

ester, NY), have formed a

strategic alliance to deliver

a comprehensive set of clini-

cal and medical imaging

services that will enable

biopharmaceutical compa-

nies to make faster, more

confident decisions on the

development of their oncol-

ogy compounds.

• Dako (Glostrup,

Denmark) and Quintiles

(Durham, NC) have

formed a strategic alliance

to advance personalized

medicine by collaborating

on the co-development

of targeted therapies and

companion diagnostics.

Awards• Rabinder Buttar, PhD,

President and CEO of

ClinTec International

(Glasgow, Scotland), was

named Female Business

Leader of the Year at the

2010 Scottish Leadership

Awards held in Glasgow.

• Mid*Lands IRB (Overland

Park, KS) has been awarded

accreditation by the Asso-

ciation for the Accreditation

of Human Research Protec-

tion Program.

• Almac’s (Souderton, PA)

Clinical Technologies busi-

ness unit, a part of Almac

Group, has been named one

of the Best Places to Work

in PA for 2010.

Company News• The European Medicine

Agency (London, England)

and the European Network

of Centers for Pharmacoepi-

demiology and Pharmaco-

vigilance (London, England)

have awarded the first EN-

CePP study seal to an obser-

vational study researching

hospitalized patients with

Chronic Obstructive Pulmo-

nary Disease.

• A Phase III trial for Ae-

gerion Pharmaceuticals

(Bridgewater, NJ) that was

conducted by ACR Image

Metrix (Philadelphia, PA)

was published as an ab-

stract in the online supple-

ment of Atherosclerosis

and presented at the 78th

European Atherosclerosis

Society Congress.

• The former management

team for Addrenex Phar-

maceuticals has launched

a new company, Neuronex

Inc. (Morrisville, NC), a

specialty pharmaceutical

company that develops and

commercializes drugs to

treat central nervous system

diseases and disorders.

• US Oncology (The Wood-

lands, TX) has enrolled the

1,000th patient in a Phase I

clinical trial through its US

Oncology Research Network.

• Galderma (Fort Worth,

TX) has standardized on the

Medidata (New York, NY)

Rave electronic data capture

and clinical data manage-

ment platform.

• Almac’s Clinical Technolo-

gies Division has moved into

the Almac Group’s new

North American Headquar-

ters in Souderton, PA. The

company has also success-

fully completed an inspec-

tion of its Clinical Services

UK facility, located in

Craigavon, by the Medicines

and Healthcare products

Regulatory Agency.

• Perceptive Informatics

(Boston, MA) has incor-

porated IBM’s WebSphere

portal and Tivoli Access

Manager into its eClinical

platform, which provides

support for its eClinical

Suite.

New Facilities• Partnering with Sun Labs

(Menlo Park, CA), Oracle

(Redwood Shores, CA) has

created the Oracle Health

Sciences Institute in order

to focus on research that

will accelerate IT innovation

to advance personalized

medicine and drug delivery.


has opened an office in No-

vosibirsk, Russia in order

to strengthen its presence

in the region. The company

has also consolidated its

clinical development opera-

tions in Beijing, China, in a

new, larger office to support

its growing client base in

the country and throughout

Asia Pacific.

• Clinical Research Ad-

vantage (Tempe, AZ) has

expanded into the Omaha/

Council Bluffs market with

the opening of three local

area offices in Omaha, Bel-

levue, and Council Bluffs.

Products• Trianz Solutions (Herndon,

VA) has released Version

6.1 of the Acceliant eClini-

cal Suite for web-based

clinical trial management

and data collection. The

new version of Acceliant

provides trial builders the

ability to define and import

CRF metadata in commonly

available formats.

• Oracle Health Sciences

(Redwood Shores, CA)

released Oracle Clinical De-

velopment Analytics 2.0 and

Oracle Life Sciences Data

Hub 2.1.4

• BioClinica (Newtown, PA)

has released its new IVR/

IWR platform, Trident IWR,

whose interface provides

clinical operations person-

nel with a way to directly set

up, monitor, and maintain

randomization and supplies

for clinical trials.

• PharmaVigilant (Westbor-

ough, MA) has enhanced

its InSpire electronic data

capture system to support

multiple languages for the

management of complex,

large-scale global trials.

• Pegasystems (Cambridge,

MA) released its Adverse

Event Case Processing

solution that collects, man-

ages, and analyzes adverse

events both during and af-

ter clinical trials.

20

To Register for the 2011 program and place your nomination

for the Hall of Fame Awards, visit us online at

www.clinicaltrialpartnerhsips.com

NOMINATION CATEGORIES

Announcing the


Partnerships in Clinical Trials event will host it’s


ceremony to honor and celebrate the Partnerships

MVPs throughout the past 20 years.

Technology and Innovation

Lifetime Achievement

Operational Excellence

Change Management

Most Valuable Attendee

-ARCH�� !PRIL��s�0HOENIX�#ONVENTION�#ENTER�s�!RIZONA


To have your event considered, contact Kayda Norman at [email protected] or (732) 346-3035.

>> For a comprehensive calendar of events see appliedclinicaltrialsonline.com

Calendar of Events

February15-16: Clinical Trial Material

CMC, Fast Track to Proof of

Concept, Frankfurt, Germany.

Contact: SMi

15-17: Electronic Document

Management 2011: The Inter-

section of Data, Documents

and Submissions, National

Harbor, MD. Contact: DIA

16-17: Writing in the Regulated

Environment When English is

your Second Language, King of

Prussia, PA. Contact: CfPIE

17-18: Standard Operating

Procedures (SOPs) Develop-

ment and Implementation,

Las Vegas, NV. Contact: SoCRA

17-18: Pharmaceutical Regula-

tory Affairs in the Middle East,

London, UK. Contact: Manage-

ment Forum

17-19: 2011 Genitourinary

Cancers Symposium, Orlando,

FL. Contact: ASCO

18: Clinical Research Profes-

sional Certification Prepara-

tion and Review Course, Las

Vegas, NV. Contact: SoCRA

21-23: Marketing Pharma-

ceuticals 2011: Workshop for

Regulatory Professionals and

Promotional Review Teams,

Washington, DC. Contact: DIA

21-24: 2011 ISPE Tampa Confer-

ence, Tampa, FL. Contact: ISPE

21-25: Training Course on

Excellence in Pharmaco-

vigilance: Clinical Trials and

Post Marketing, London, UK.

Contact: DIA

23: Preclinical and Clinical

Imaging for Drug Develop-

ment—A Virtual Conference,

9:30 a.m. to 6 p.m. Contact: CBI

23: Understanding the Impact

of Statistics on the Design,

Conduct, and Reporting of

Clinical Trials Webinar, 12:00

p.m. to 1:30 p.m. Contact: ACDM

23-24: 7th Annual Forum on

Late Phase Research, London,

UK. Contact: CBI

23-25: Training Course on

Clinical Project Management,

Basel, Switzerland. Contact: DIA

23-25: Strategies for Clinical

Oncology Drug Development,

San Francisco, CA. Contact: CHI

23-25: Translational Science,

San Francisco, CA. Contact: CHI

23-25: Validaiton and GMP

Compliance Week: Achieve

Manufacturing Excellence

through Optimal Quality

Practice, TBD. Contact: IVR

24-25: Coordinating a Clinical

Trial, Coral Springs, FL. Contact:

MRM

24-25: INDs/NDAs/CTDs, New

Brunswick, NJ. Contact: CfPA

28-March 1: Adverse Drug

Effects—Reporting and

Regulatory Requirements,

Berlin, Germany. Contact: CfPIE

March2-3: FDA Clinical Trial Require-

ments Regulations, Compli-

ance, and GCP Conference, San

Francisco, CA. Contact: SoCRA

2-3: An Overview of Pharma-

coepidemiology, Arlington, VA.

Contact: PERI

2-3: IQ, OQ, PQ, Amsterdam, The

Netherlands. Contact: CfPA

2-4: Drug Development

Process-From Discovery

to Communication, Berlin,

Germany, Contact: CfPIE

3-4: Preparation of FDA

Submissions (INDs, NDAs,

BLAs, ANDAs, Post-Approval

Supplements) and Communi-

cating with the FDA, King of


6-9: SGO’s 2011 Annual

Meeting on Women’s Cancer,

Orlando, FL. Contact: ASCO

6-11: 46th Annual Arden

Conference: Pharmaceutical

Development of Biologics,

West Point, NY. Contact: AAPS

7: Medical Devices: Demystify-

ing Regulation and Guidance,

Arlington, VA. Contact: PERI

7-8: Clinical Document

Management—A Trial-by-Trial

Approach to Compliance, Los

Angeles, CA. Contact: CfPIE

7-9: Good Clinical Practices

(GCPs), Berlin, Germany.

Contact: CfPIE

8-9: Applying Pharmacokinet-

ics and Pharmacodynamics

for Regulatory Submissions,


9-11: EudraVigilance Train-

ing—Electronic Reporting of

ICSRs in the EEA, London, UK.

Contact: DIA

10-11: DIA/ FDA Practices

for Regulatory Information

Synthesis of Randomized

Trials for Product Safety

Evaluation, Bethesda, MD.

Contact: DIA

14-15: Clinical Trial Design

for Medical Devices, King of


14-15: Basic Drug Develop-

ment, Arlington, VA. Contact:

PERI

14-15: Developing Specifica-

tions for Drug Substances and

Drug Products, Amsterdam, The





14-16: BIO-Europe Spring 2011,

Milan, Italy. Contact: BIO

14-18: Clinical Science Courses,

Philadelphia, PA. Contact:

SoCRA.

AAPS: American Association

of Pharmaceutical Scientists,

(703) 243-2800,

www.aapspharmaceutica.com

ACDM: Association for

Clinical Data Management,

+44 1727 896080

ASCO: American Society of

Clinical Oncology,

(571) 483-1300, www.asco.org

BARQA: British Association

of Research Quality

Assurance, +44 1473 221411,

www.barqa.com

BIO: Biotechnology Industry

Organization, (202) 962-9200,

www.bio.org

CBI: Center for Business Intel-

ligence, (781) 939-2400,

www.cbinet.com

CfPIE: Center for Professional

Innovation and Education,

(610) 688-1708, www.cfpie.com

CfPA: Center for Professional

Advancement, (732) 238-1600,

www.cfpa.com

CHI: Cambridge Health Insti-

tute, (781) 972-5400,

www.healthtec.com

DIA: Drug Information

Association, (215) 442-6100,

www.diahome.org

ExL Pharma: (212) 400-6240,

www.exlpharma.com

ICR: Institute of Clinical

Research, +44 1628 899755,

www.instituteofclinical

research.com

IIR: Institute for International

Research, (888) 670-8200,

www.iirusa.com

ISPE: International Society of

Pharmaceutical Engineering,

(813) 960-2105, www.ispe.org

Management Forum:+44 (0) 1483 0570099,

www.management-forum.co.uk

MRM: Medical Research

Management, (877) 633-3322,

www.cra-training.com

NextLevel Pharma: +421 232

662 621, www.nextlevelpharma.

com

PDA: Parenteral Drug

Association, (301) 656-5900,

www.pda.org

SMi: +44 20 7827 6000.

www.smi-online.co.uk

SoCRA: Society of Clinical

Research Associates, (800)

SoCRA92 or (215) 822-8644,

www.socra.org


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Contact: DIA

7-8: SoCRA Clinical Site

Coordinator/Manager

Program for Coordinators,

Research Associates, Study

Nurses, and Site Managers

Registration, Toronto, Ontario.

Contact: SoCRA

7-8: 2011 RAPS Horizons:

Regulatory and Beyond,

Vancouver, Canada.

Contact: RAPS




Contact: DIA

11-14: ISPE Frankfurt Confer-

ence, Frankfurt, Germany.

Contact: ISPE

11-15: 2011 PDA Annual

Meeting, San Antonio, TX.

Contact: PDA

12-14: Bio-IT World Conference

and Expo, Boston, MA.

Contact: CHI

13: Biosimilars and Follow-

on Biologics, Arlington, VA.

Contact: PERI

14-18: Clinical Science Courses,

San Francisco, CA. Contact:

SoCRA

15-16: IQ, OQ, PQ, Burlingame,

CA. Contact: CfPA

16-17: Clinical Data Quality

Summit, Arlington, VA.

Contact: DIA

21-22: The EU Clinical Trial

Directive, King of Prussia, PA.

Contact: CfPIE

21-22: INDs/NDAs/CTDs,

Amsterdam, The Netherlands.

Contact: CfPA

21-22: 3rd Annual Bio/Pharma-

ceutical Drug Safety Forum,

Philadelphia, PA. Contact: CBI

21-22: The Institute of Clinical

Research 32nd Annual Confer-

ence and Exhibition, Brighton,

UK. Contact: ICR

21-23: Analytical Methods

Validation for FDA Compli-

ance, New Brunswick, NJ.

Contact: CfPA

22-23: Implementing Good

Clinical Laboratory Practice,

Cambridge, UK. Contact: BARQA

24-25: Advanced Site Manage-

ment: Finance and Produc-

tivity Enhanced Business

Practices for Clinical Research

Programs, Jersey City, NJ.

Contact: SoCRA

24-25: 3rd Annual Forum

on Payers on Personalized

Medicine, Washington DC.

Contact: CBI

24-25: 4th Annual Clinical Trial

Management Systems (CTMS),

Philadelphia, PA. Contact: CBI

24-25: Advanced Cancer

Course “International Clinical

trials Workshop” (FLASCA),

Punta del Eeste, Uruguay.

Contact: ASCO

28-29: The 3rd Annual Digital

Pharma Europe, Ingelheim,

Germany. Contact: ExL Pharma

28-29: Cardiovascular Drug

and Device Development,


28-30: 23rd Annual EuroMeet-

ing, Geneva, Switzerland.

Contact: DIA

28-30: Pharmaceutical Process

Development, Amsterdam, The


30-31: Prescription Drug

Labeling Regulations: US,

Canada and EU, Arlington, VA.

Contact: PERI

30-April 1: 20th Annual

Partnerships in Clinical Trials,

Phoenix, AZ. Contact: IIR

April4-5: Good Laboratory

Practices (GLP) for Pre-Clinical

Testing, King of Prussia, PA.

Contact: CfPIE

4-5: Global Regulatory Affairs:

An Overview of Drugs and

Biologics (incl. EU Clinical

Trial Directive), Arlington, VA.

Contact: PERI

4-6: 2nd Annual Proactive

GCP Compliance, Westin

Arlington Gateway, VA.

Contact: ExL Pharma

5-6: Research Quality Assur-

ance for Good Laboratory

Practice, Cambridge, UK.

Contact: BARQA

5-7: Medical Device Regula-

tory Affairs, Denham, UK.

Contact: TOPRA



ALMAC Group . . . . . . . . . . . . . . . . . . . . . . 7

Aptuit Inc . . . . . . . . . . . . . . . . . . . . . . . . 29

AtCor Medical . . . . . . . . . . . . . . . . . . . . . 43

Barnett Educational Services. . . . . . . . . 17

BIO International . . . . . . . . . . . . . . . . . . 25

Biomedical Systems . . . . . . . . . . . . . . . . . 3

Cetero Research . . . . . . . . . . . . . . . . . . . 15

DaVita Clinical Research . . . . . . . . . . . . 41

ERT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Emedcareers . . . . . . . . . . . . . . . . . . . . . . . 8

IRB Services . . . . . . . . . . . . . . . . . . . . . . 45

ICON Medical Imaging . . . . . 31, 33, 35, 37

IIR Partnerships . . . . . . . . . . . . . . . . .47, 53

INTERLAB Central Lab Services

—Worldwide . . . . . . . . . . . . . . . . . . . . 27

Marken . . . . . . . . . . . . . . . . . . . . . . . . 18ab

Medpace Inc . . . . . . . . . . . . . . . . . . . . . . . 9

Novella Clinical . . . . . . . . . . . . . . . . . . . . 13

Oracle Health Sciences . . . . . . . . . . . . . . 59

PRA International . . . . . . . . . . . . . . . . . . 39

PAREXEL International . . . . . . . . . . . . . . . 2

Perceptive Informatics . . . . . . . . . 11, 20-21

PharmaNet . . . . . . . . . . . . . . . . . . . . . . . 23

QualityMetric . . . . . . . . . . . . . . . . . . . . . . 5

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Standard of Care in Study BudgetingSurvey reveals industry practices

surrounding standard of care and

insurance claims data.

Harold e. Glass

Pharmaceutical executives readily acknowledge that

their industry faces a number of broad challenges,

not the least of which are the escalating costs of de-

veloping new drugs and a weak public image.1 Both

issues intersect in one area of drug development:

clinical grants. Based upon an industry survey of people

working in clinical operations, and an analysis of grant pay-

ments from the perspective of standard of care (SOC), this

article argues that cost management and fair market value

can be far more effectively addressed than has been the prac-

tice to date.Clinical grants represent a major and growing cost of

developing new drugs. These rapidly increasing costs have

been extensively documented and analyzed, 2 and the re-

search suggests that clinical trials are the largest single area

of R&D operating expenses, with clinical investigator grants

representing the bulk of these costs. Many drug develop-

ment managers appreciate the need to control clinical trial

costs. One important, if underappreciated, approach involves

avoiding double payments for activities that would be nor-

mally covered by third-party payers (including Medicare and

Medicaid in the United States) as part of the standard care

that any patient would receive at that clinical research site,

whether or not that patient is part of a clinical trial. While

sites are ethically prohibited from enrolling a patient in a

clinical trial if that patient would not otherwise be treated

for the illness being studied, many of these patients would

be partially covered by third-party payers as part of the stan-

dard of medical care.Understanding the standard of medical care, however,

can be particularly dif f icult when studies involve mul-

tiple countries. At one end of the health continuum some

countries are moving toward national medical

treatment protocols—the UK’s National Health

Service is one example. While health care in

many countries has one dominant payer, few

countries have just one agency delivering almost

all their health care, as is the case in the UK. In

sharp contrast, the United States has multiple

payers and health care delivery organizations.

Such differences challenge clinical development

teams as they seek to establish medical standard

of care guidelines for clinical trial grant pay-

ments. In the United States, however, it is easier

to establish what constitutes standard of care

through the payment practices of third-party

payers.A second pharmaceutical industry challenge is

the changing relationship with physicians. After

intense scrutiny from both within and outside

the industry, pharmaceutical companies have

now developed more stringent guidelines about

what they can give to prescribing doctors. For

instance, new guidelines prohibit gifts of any sort,

restrict meals to those associated with actual

medical education, and prohibit industry em-

ployees from giving any other objects to medical

professionals. Some pharmaceutical industry observers are

also concerned about the financial relationship be-

tween investigators participating in clinical trials

and the companies sponsoring the trials. These

observers have questioned whether the grant

amount for a clinical trial reflects payment only for

work performed or whether the payment might be

an attempt to influence investigator behavior. In

these instances, the foremost concern is whether

investigators are being paid at fair market rates or

at inflated rates that might influence their behav-

ior. 3 While some published research links relative

grant payment levels with subsequent investigator

Sites

Your Peer-reviewed Guide to Global CliniCal trials ManaGeMent appliedclinicaltrialsonline.com

1992–2010

ACT

Year of Servi ce

Volume 19, Number 7 July 2010

InsId

e

Protecting Subjects:

The IRBs Next Steps

➤ SiteS

incorporating Standard

of Care in Study Budgets

Benefits of CtMS

at the investigative Site

Also in this issue

■ FDA Transparency Efforts to Impact Research

■ Survey Assesses Europe’s Clinical Trials Directive

■ Tapping into the Potential of Pharmacists

■ Biosimilars Make Headway in the U.S.

Complete contents on pages 6 & 8

EU LEGAL SERVICES

EU Legal Representative. All 27 EU countries

require an EU based legal entity for clinical trials.

Our UK based Chartered Accountants form a UK

legal entity in 48hrs. Low fees – prompt service.

www.TopazClinical.com


To see more A Closing Thought articles,

visit appliedclinicaltrialsonline.com

A Closing Thought

We can postulate that suitable dose-effect

relationships were demonstrated in Phase

II clinical trials for these failed drug proj-

ects. Rather than infer that preclinical

research through Phase II has suddenly

become error-prone, there is merit in as-

sessing the validity of Phase III clinical

trials today.

Until the late 80s, Phase III trials were

conducted essentially in North America

and/or Europe. The drug pipeline deliv-

ered twice as many innovative medicinal

products annually. Clinical research

globalized over the last two decades by

following the path of diminishing GDP per

capita. The evidence comes from plotting

the year of the first FDA inspection in any

particular country versus GDP per capita

in that country.

Our research evaluated the clinical trial

participation of sites in North America

and in Europe in Phase II and III industry

trials in the period 2004-2006 compared

with 2007-2009. North America partici-

pated in 60% of Phase II trials worldwide

in both periods, twice more than Europe.

The complexity of trial protocols is grow-

ing fast in Phase II, driving up the costs

of procedures and labs. According to a

Tufts Center for the Study of Drug Devel-

opment news item from May 5, 2010 the

high medical technology content of Phase

II studies may explain the dominance of

North American sites in Phase II trials.

The same report notes that Phase III

protocols are less likely to increase in

complexity. Hence, the position of North

America in Phase III is seriously under-

mined by globalization: North American

sites participate only in 30% of Phase III

trials worldwide. In 2007-2009, North

American and European sites have seen

their respective shares in Phase III trials

decline in favor of the rest of the world.

We can assume that the diminishing

participation of North American and Euro-

pean sites in Phase III trials is even worse

in terms of patients enrolled. Understand-

ably, it is cost effective for sponsors to in-

clude sites from low-cost countries in large

Phase III studies, where, in addition, par-

ticipants are potentially more incentivized.

Indeed, the lower the local standard of care

compared to that offered in the trial, the

greater the incentive for patients to take

part. To make matters worse for sites in

North America and Europe, recruitment

periods are being closed prematurely as a

function of global sample size completion.

The quality of Phase III trials is weak-

ened further by massive differences be-

tween sites. Biostatisticians do not censor

data for these conditions. Just one exam-

ple regarding concomitant medications:

WHO puts a ceiling of 1% of market value

on the amount of medicinal products in

North America and most of Europe which

are counterfeit, but the estimate is at least

10% with no ceiling for other regions of

the world. The most puzzling paradox is

that health authorities in North America

and Europe accept evidence from coun-

tries from which they do not recognize

the diplomas of doctors and other health-

care personnel who produce the data.

In conclusion, as addressed in this

space in April 2010, data from healthcare

systems with health outcomes signifi-

cantly worse than in North America and

Europe comes cheaper, but may jeopar-

dize the overall success rate of new drug

projects coming out of Phase II. ❏

A recent study (2010 Pharmaceutical R&D Factbook) indicates that

the decade-long drop in the overall success rate of pharmaceutical

R&D continued in 2009. The authors found that “the number

of experimental drug projects terminated at the final Phase III stage of

development had doubled in 2007-2009 compared with 2004-2006.”

Until the late 80’s, Phase III trials were

conducted essentially in North America

and Europe.

Jean-Pierre Tassignon, MD, PhD, President and CEOCrossover CRI [email protected]

Deteriorating Quality in Global Trials

20 of the 20 Top Pharmas

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