Site Landscape
Asia-Pac Site Solutions Summit
2016
Christine Pierre
President
SCRS
#SCRS16 1
The Site Landscape
• Connecting patients to clinical trials through thousands of disease specific social media
patient communities.
• Over 1,000 research sites globally list their clinical trials on StudyKIK and are being
connected to qualified patients.
• Has built multiple tools for research sites to easily communicate with patients signing up
for the local clinical trials through StudyKIK.com including a instant patient text message
conversation tool & automatic appointment reminder system to name a few.
• StudyKIK's goal is to allow patients to easily find approved clinical trial information on a
local site level and give research sites the tools needed to easily streamline the
enrollment process.
Disclaimer • Any reference to companies is not an endorsement or statement of their
services.
• Check with your professional consultants (legal, financial, HR, etc.) to
obtain specific information pertaining to your company.
• This information is not meant to direct you on how to address any specific
issues.
• Antitrust–compliance policy adherence.
http://myscrs.org/24-revision-v1/policies/antitrust-compliance-policy/
2016 Asia-Pac Community Australia & New Zealand Ambassadors
Gina Kennedy - Chair Radhika Butala Radhika Butala Tam Nguyen
Tam Nguyen Megan Robertson Megan Robertson Jenny McGrath
Jenny McGrath Cheryl-Ann Hawkins Cheryl-Ann Hawkins April Josephsen
Anne Woollett Annette Corbitt April Josephsen Catherine May Elizabeth Wilson Katie Kennett
Katie Kennett Rachel Harris Carolyn Stewart Simon Carson
Todd Albin
Thank You!
A Trade Organization Founded in 2012
Unify the Voice of the Global Clinical Research
Site Community for Greater Site Sustainability
2,800
42
Sites Strong
& Growing
Countries
SCRS Membership
50%
28%
14%
8% Practice
Freestanding
Hospital
Academic
11% Emerging Sites • 2% Developing Countries
5% Asia-Pac Region
82% 10+ yrs experience • All TA
• Drugs • Devices • Biologics
Sites Strong
& Growing
Member Benefits
Advocate Educate Connect Mentor
Advocate Educate Connect Mentor
• Members’ perspectives and voices
represented by SCRS to regulatory
agencies and industry stakeholders
• Promote your commitment to site
sustainability by proudly displaying the
SCRS logo
• Obtain TransCelerate GCP and EDC
recognized training for your site’s staff
• Gain critical insight from monthly and
featured webinars
Good Business Practices
Good Clinical Practices
Good Technology Practices
The Hidden Costs of
Conducting Clinical Research
at the Site
Inspection Readiness
• Receive critical information and stay
up-to-date with shifting trends and
practices through SCRS’ expert-driven
content
• Address site challenges through
exclusive thought leadership content
available in SCRS’ global journal,
InSite
• Access SCRS’ Study Opportunity
Platform, a hub where sponsors and
CROs provide study opportunities to
SCRS members
• Maximize your site’s exposure to
leading sponsors and CROs on
SCRS’ Member Site Directory
• Expand your membership
experience through participation in an
SCRS Community
Asia-Pac Summit
• Engage with industry stakeholders
and drive positive results through
participation in a Site Advocacy
Group (SAG)
• Access SCRS’ ListServ, a dynamic
and engaging platform for members
that facilitates positive change through
discussion and debate among your
peers
• Find solutions to business and
marketplace challenges through
SCRS’ mentorship program
• Join the Ambassador program and
bring more of SCRS to your region of
the world
Acurian
Australia Centralized Enrollment
& Retention
BMS
Protocol Review
EMD Serono
Protocol Review
Merge
Investigator Performance
Inventiv Health
INC Research
Scientific & Operational
Investigator Payments
TransCelerate
Shared Investigator Platform
E-Consent
E-Labels
Common Protocol Template
Patient Awareness and Access
Lilly
Innovation
SCRS Multi-Stakeholder Initiatives
13
Collaboration with TransCelerate Clinical Practice vs Clinical Research
Clinical Research Overview
Delegation and Training
Facilities and Equipment
Conducting a Study
IRB Ethics and Informed Consent
Essential Documents for a Clinical Study
Source Documentation
Investigational Product
Adverse Events and Safety
Monitoring and Auditing
Collaboration with CTTI
Your Summit Experience • No Whining, No Witching
• Focus on SOLUTIONS
• Have fun & meet lots of people!
Make the SCRS Connection THE PROTOCOL FOR SELFIES WITH FRIENDS
1 Experiment with angles
2 Stand in the light
3 Accessorize
4 Pose with someone new
5 Do something interesting – smile!
6 Adjust your shoulder placement
7 Show you’re having fun
8 Extend your neck forward
9 Hang out with cool/fun people: Summit People!
10 Post to social media
6 Site Solutions I Want to Share with You
1. Study Opportunities
2. Feasibility
3. Contracts
4. Site Study Dashboard
5. RBM
6. Site Payments
Top 11 Pharma Companies by R&D Spend
Novartis Johnson & Johnson
Roche AstraZeneca
Pfizer GlaxoSmithKline
Merck & Co. Lilly
Sanofi Amgen
Bristol-Meyers Squibb
Source: EvaluatePharma 2015
Therapeutic Areas of Focus Therapy Area Count As a % Oncology & Immunomodulators 8,864 34%
Systemic Anti-infectivies 4,080 16%
Central Nervous System 3,572 14%
Various 1,497 6%
Musculoskeletal 1,211 5%
Cardiovascular 1,154 4%
Endocrine 1,064 4%
Respiratory 996 4%
Gastro-Intestinal 973 4%
Dermatology 831 3%
Sensory Organs 775 3%
Blood 596 2%
Genito-Urinary 557 2%
Total 26,171
Source: Evaluate Pharama 2015
Geographic R&D Spend
78.3%
15.2%
1.9% 1.1% 1.4% 0.5% 0.1% 0.1% 0.3% 0.0%
10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%
Source: Evaluate Pharama 2015
FDA (CDER) 2014 Inspections Africa 1% Asia/Pac
5% AUS 1% Canada
4%
Eastern EU 6%
Latin Amer 3%
Middle East/ Central Asia
1%
USA 74%
Western EU 5%
Source: PAREXEL Consulting May 2014
1. SCRS Study Platform Opportunities SCRS & have partnered to develop the Study Platform
It will provide:
Opportunities for companies to engage with SCRS member sites
Opportunities for SCRS members to proactively connect with companies and be evaluated
for potential participation in upcoming trials (access through secured member only portal) \
it does NOT guarantee site selection
SCRS invites other organizations to join the SCRS Study Opportunity Platform and engage
with committed sites
Pilot Includes:
Feasibility: A Two Way Dialogue
Site Process
• 55% of sites provide a “Site CV” (info about their site)
– 59% - during feasibility
• 82% provide a Study Questionnaire (seeking study information)
• 52% require it returned prior to site selection
Source: SCRS Feasibility Survey 2015
How Was it Received? • 55% of sponsors/CROs report having received a Site CV
– 85% helpful in shortening the start up process
• 94% said they would be interested in receiving such a form
– 62% want it during feasibility
• 37% report having received a Study Questionnaire
– 95% would provided the information requested
– 48% said they can typically provide the information requested
Source: SCRS Feasibility Survey 2015
2. SCRS Feasibility Process & Tools
• White Paper & Tools
– Site CV template & Study Questionnaire
• Webinars
• Workshops
CHAIR
Vivienne van de Walle, MD, PhD, CPI
Medical Director & Owner
PT&R
3. Clinical Language Evaluation &
Reconciliation Charter (CLEAR)
• Addressing contract clauses “that matter”
Protocol Complexity
0
10
20
30
40
50
2000-2002 2003-2005 2006-2008 2009-2011 2012-2015
Pro
toco
l C
om
ple
xity (
Me
dia
)
Source: Medidata - N = 8275 studies, phase II & III, all TAs
Screen Failure Trends
0
10
20
30
40
50
2006 2007 2008 2009 2010 2011 2012 2013 2014
Scre
en
Fa
ilure
Ra
te
(Media
n)
Source: Medidata: studies > 10 sites N = 657 studies, phase II & III, all TAs
Screen Failure Rate
Source: Medidata Enrollment closed, studies > 10 sites, N = 657 studies, phase II & III, all TAs
Non Enrolling Sites By Country 1. South Korea
2. Japan
3. Bulgaria
4. Ukraine
5. Taiwan
6. Romania
7. Hungary
8. Czech Republic
9. Russia
10. Belgium
11. Spain
12. Poland
13. Canada
14. Sweden
15. Australia
16. United Kingdom
17. United States
18. Italy
19. Austria
20. France
21. Germany
22. Mexico
23. Netherlands
24. Argentina
25. Brazil
37 Source: Medidata *Phase 2 & 3 Only, 2010-2015 studies with closed enrollment ** where N > 150 studies
1. Brazil
2. South Korea
3. Japan
4. Sweden
5. Argentina
6. Austria
7. Bulgaria
8. Canada
9. Czech Republic
10. France
11. Germany
12. Hungary
13. Italy
14. Mexico
15. Netherlands
16. Romania
17. Spain
18. Ukraine
19. United Kingdom
20. Russia
21. Australia
22. Taiwan
23. United States
24. Poland
38
High Enrolling Sites By Country
Source: Medidata *Phase 2 & 3 Only, 2010-2015 studies with closed enrollment ** where N > 150 studies
Patient Reimbursement/Visit Worldwide 2012 – 2015 (Phase II & III)
$44
$49
$48
2012 2013 2014
Source: IMS Health May 2015
Patient Stipends
40
86
60
53
50
50
50
47
44
44
37
36
33
Ophthalmology
Devices & Diagnostics
Blood Disorders
Infection Disease
CNS
Pain
Musculoskeletal & Connective Tissue
Respiratory
Oncology
Genitourinary System
Dermatology
Cardiovascular US Dollars
Source: IMS Health May 2015
Do the Sponsors/CROs share…
24%
21%
61%
63%
15%
16%
0% 20% 40% 60% 80% 100%
...their performancemetrics for your site?
...any “benchmarking” information, so that
you can put your site’s performance …
Yes No Unsure
Source: SCRS Summit Survey 2013
Give The Sites What They Need & Want
• 79% of sites report a desire to receive a Site Study
Dashboard
• 62% indicate receiving such feedback would
definitely allow them to improve the quality from
their site
Source: Site Solutions Summit 2013
Allergan Site Study Dashboard Project
• 71% found the metrics were helpful or extremely
helpful
• 100% indicated they use the data when received to
course correct and build a stronger site foundation
4. Site Study Dashboard Quintiles, Allergan, Apostle Site: Co-Chairs
• Identify metrics to be measured
• Format & frequency to provide sites feedback
nimblif y
Risk Based Monitoring – What Is It?
…strategies for monitoring activities that reflect a
modern, risk-based approach that focuses on critical
study parameters and relies on a combination of
monitoring activities to oversee a study effectively. For
example, the guidance specifically encourages greater
use of centralized monitoring methods where
appropriate.
FDA: Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
Reasons for RBM
39
29
42 61 29
26
44
25
82
23 0
102030405060708090
Improve DateQuality
Hot Topic of theDay
Increase PtSafety
CostEfficiencies
Regulatoryrequirement
2013 2015Percent
Source: SCRS & Linking Leaders RBM Survey 2013, SCRS Summit Survey 2015
# 1 Reason for RBM
39
29
42 61 29
26
44
25
82
23 0
102030405060708090
Improve DateQuality
Hot Topic of theDay
Increase PtSafety
CostEfficiencies
Regulatoryrequirement
2013 2015Percent
Source: SCRS & Linking Leaders RBM Survey 2013, SCRS Summit Survey 2015
Site’s Policy on Data Entry
0%
10%
20%
30%
40%
50%
60%
70%
Day of visit Within 3 days ofvisit
Within 4-10 daysof visit
When we havetime
20132014
Source: SCRS & Linking Leaders RBM Survey 2013, SCRS Summit Survey 2015
RBM Impact on Quality & Resources
40%
11%
43%
59%
72%
54%
1%
17%
3%
Regulatory Obligations
Data Quality
Site's need for QA
Increase No Change Decreased
Source: SCRS Summit Survey 2015
66%
57%
63%
6%
29%
37%
32%
72%
5%
6%
5%
22%
Work Load
Resource Needs
Costs
# of pts you can seeIncrease No Change Decreased
5. Sites are Impacting Change
• TransCelerate – Site Advocacy Group
• Intel Gathering & Collaboration
– Surveys
– White Papers
– Presentations
11% of sites fail to
enrol a single
patient;
37% under enroll1
Over the last 15
years, 86% of studies
failed to recruit on
time
Cost to maintain a site
is approximately
$1,500 per month3
2014, 65% of sites
surveyed have less
than
3 months operating
cash
Cost to initiate a site costs approximately $20,000-$30,0002
The ability to recruit and retain motivated, informed,
protocol-eligible patients starts with sites
Time, Resources, Cost
39% meet
enrolment
targets and
13% exceed1
Data and research from Society of Clinical Research Sites, 2014; 1. Tufts CSDD Impact report http://csdd.tufts.edu; 2.
Mishra E. Clinical Leader. Dec 19, 2013 http://www.clinicalleader.com/doc/; 3. Lamberti MJ, Brothers C, Getz, K.
Therapeutic Innovation and Regulatory Science. 2013;47(1):101-109
Hours Spent Pre Study – SIV Average - 40 Hours
40 42 38
42
55
42
< 250K 251-500K 501-1M 1.1-1.6M 1.7-2.1 Over 2.2 M
By Annual Revenue
Source: SCRS Summit Survey 2015
Non-Refundable Start Up Received
Sources: Site Solutions Summit Survey 2006, 2007, 2008, 2009, 2011, 2013, Drug Dev 2015
$2,376
$1,381
$2,550 $2,740
$3,205 $2,927 $3,429
2006 2007 2008 2009 2011 2013 2015
US Dollars
Average Reimbursement per Visit
Both exclude screen failures and discontinues
Source: CFS Clinical 2013, 2104, DrugDev 2015
$809
$847
$800
$880 $890
$772
$700
$750
$800
$850
$900
2013 2014 2015
w/vaccines w/out vaccines
Of Note
2000 sites were paid
~$500/visit
Protocol complexity
has increased ~50%
Overhead
0% 5% 10% 15% 20% 25% 30% 35% 40%
< 10%
11-15%
16-20%
26-30%
30% +
Source: SCRS Summit Survey 2015
Withholding Trends
Source: Site Solutions Summit 2007, 2008, 2009 & 2010, 2013 CFS Clinical n= 11,427 studies,
2015 DrugDev n= 23,810 studies
0% 20% 40% 60% 80% 100%
Guaranteed payment in 30 days
Same payment system acrosssponsors
67%
64%
77%
64%
<5 Studies 5+ Studies
Associated Value
Source: DrugDev Investigator Survey 2015; 572 responses 9 countries
80% prefer monthly payments
60% quarterly payments negatively impact study operations
85% prefer to work with sponsors and CROs that automate
& pay monthly
Source: Greenphire n=520 sites, 2016
• Education and tools focused on being a sustainable site
• Diverse patient engagement
• Best Site Practices
• Technology and Sites
• Site Advocacy Groups
• Ambassador Program:
Australia, New Zealand, Korea, Twain, Japan, UK, Poland
SCRS Forward Thinking
Our Voice. Our Community.
• Recognizes the site whose recruitment plan & execution
demonstrates dedication to innovation and excellence in patient
recruitment
• Finalists notified August 26th
• Finalists will present their ideas during the Global Summit
• Winner will be announced following the presentations
Site Patient Recruitment Innovation
Award
sitesolutionssummit.com/agenda/site-patient-recruitment-innovation-
award/
• A platform for sites to share innovative technology ideas which
would enhance their operations
• Sites will be asked to submit their ideas prior to the Global
Summit; 3 finalists will be selected by panel of independent
judges to present at the Global Summit
• Winner will be announced following the presentations
sitesolutionssummit.com/agenda/site-tank
Site Tank
71
• A leading full-service provider of clinical trial patient enrollment and
retention solutions for the life sciences industry.
• Increases the enrollment performance of investigator sites worldwide by
identifying, contacting, prescreening, and referring people who live in
the local community but are unknown to a research site.
• As a result, trial sponsors complete enrollment without incurring the
unexpected expense of adding sites, time, or CRO change orders.
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