1 EDC: THE EXPERIENCE OF A CRO. 2 INTRODUCTION Expenditure on research and development by...

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EDC: THE EXPERIENCE OF A CRO

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INTRODUCTION

• Expenditure on research and development by pharmaceutical industry is increasing worldwide and is currently estimated to be over $45 billion a year

• Despite the rise in R&D spending, there has not been a corresponding growth in the number of innovative drugs generated through such investment

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INTRODUCTION

One key bottleneck of turning biomedical innovations into actual product has been the design and execution of critical clinical trials to prove the

safety and efficacy of various innovative biomedical products while balancing regulatory pressures with a constant drive to control costs and improve quality

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INTRODUCTION

It is widely believed that the adoption and use of information technology is critical in helping

companies to satisfy these demands within the clinical operating environment

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INTRODUCTION

However, although technology dominates almost every aspect of our lives, from moving money safely, securely

and predictably around the world without pen or signature to purchasing anything imaginable over the

Internet………

in data collection from clinical trials “paper” is still king

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INTRODUCTION

Among the different technological solutions to be used in clinical trials, the “internet approach” offers the advantages of the combination of the desired targets in R&D:

a) high qualityb) shorter timec) lower costs

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WHY THE INTERNET?

• Growing popularity/accessibility

• Many uses- business- personal- very low users barrier

• Still a number of concerns but progressively solved- privacy/security- data integrity- bandwith

• Integrating with other technologies

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INTERNET APPLICATIONS FOR TODAY’S CLINICAL TRIAL

• Ethics submissions

• Patient recruitment

• Monitoring

• Patient education and communication

• Professional education (e-learning)

• Virtual Investigators’ meeting (video streaming)

• Electronic data capture

• Data Management

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THE E-CLINICAL TECHNOLOGY MARKET

Total spending in 2004 for external ECT solutions – hardware, software applications and implementation services – was an estimated $200 million. Presently, 15% of all newly initiated clinical trials are using e-clinical technologies suggesting a total potential ECT market of $1 billion to $1.3 billion if sponsors elect to use external vendor solutions

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The market is growing by 23% annually. Experts expect market growth to accellerate modestly due to the following key factors:

FDA support for CDISC’s data submission standards has added credibility

Investment capital continues to flow into the eClinical market at a significant level

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The market continues to consolidate as smaller players exit or are acquired

Growing numbers of biopharmaceutical companies have been publicly reporting speed, quality and cost advantages in support of eCT solutions

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According to recent surveys, vendor solutions are offering improved functionality and performance

Technology provisioning costs are dropping as adoption increases

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WHAT INFORMATION EXISTS PROVING THE VALUE PROPOSITION OF EDC?

The definition of value can be defined in: - direct economic (defined as pure cost-savings)- indirect economic (defined as opportunistic benefits such as the chance to increase revenue resulting from enhanced productivity) - societal implications (defined in this market as getting valuable drugs to market faster or preventing harmful drugs from being unduly exposed to patients)

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The three most important criteria to improve in any product development effort are:

QualityTime Cost

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In market of drug and device development these factors are likely in the correct order and given the fact that approved products eventually sell for hundreds of million dollars annually, each of these factors have significant economic implications These three “metrics” have all been shown to be significantly impacted through the proper use of EDC

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Comparison of metrics between EDC and paper methods in two Phase II clinical trials with the

same drug and similarly sized projects ( by Banik, et al : Bayer Pharmaceuticals 1998)

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Tasks Paper-based trial Web-based trial (EDC)

Paper CRFs Yes No

Printing and shipping of CRFs

Yes No

Data entry Double-key by Sponsor Entered once by site

Edit and logic checks Using statistical software At time of data entry

Query management Paper forms Electronic records

Data Management Paper forms Instantaneous audit trail

Monitoring All done in field In field and in office (Reduction of 20-80%-

project dependent)

Problems identified At site In advance

Problems resolved After site visit Before site visit

ITEMIZATION OF EFFICIENCIES AND ADVANTAGES OF EDC OVER TRADITIONAL MANUAL METHODS

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EDC vs PAPER: COST COMPARISON

Indication # Pts # Sites Paper orEDC?

Total PriceEURO

DifferenceEDC/paper

Cardiology 400 40PapereDC

1.428.000,001.190.000,00 - 20%

Atopy 900 75PapereDC

666.315,00569.500,00 - 17%

Oncology 1000 40PapereDC

1.159.940,00983.000,00 - 18 %

Crohndisease 192 16

PapereDC

248.000,00240.000,00 - 1,6 %

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EDC IN CLINICAL TRIALS :International experience

AREAS OF COSTS SAVINGS

The following are estimated cost eliminations of a 40 center, multicenter study with 1,000 patients and a

100 pages Case Report Form (CRF):

Source: www.targethealth.com

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• Printing of the CRF:

This cost can be as high as $100/book. For 1,000 patients, this represents a cost elimination of $100,000 plus resources to ship and direct shipping costs


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• Double-Key Data Entry:

This cost can be as high as $3/pagex2. For a 100 page case book and 1,000 patients, this represents a cost elimination of $600,000


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• Query Management:

In a case study comparing a paper query management system with an electronic online system using edit and logic checks, there was a 65% reduction in queries. For the current hypothetical study, there would be a reduction from 3,000 paper queries to approximately 1,000. Using an estimated in-house cost of query management of $50/query, there would be a savings of approximately $100,000


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• Monitoring:

Since many monitoring problems can been identified in advance, there can be a reduction of at least one monitoring trip, as well as a reduction of time spent at the study site. Even if just one trip and an additional one day of monitoring is saved for each study site, for a multicenter study with 40 sites, the savings for one day of travel, one day of monitoring and travel costs could run up to $3,000/site.The total savings in this case would be $120,000


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THE RISK OF EDC MISPERCEPTION

• The poor team workflow destroys the value proposition of EDC contributing to the misperception that “EDC is too expensive”

• In technology circles this is explained by the equation of

New Technology + Old Process = Very Expensive Old Process(NT) (OP) (VEOP)

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THE RISK OF EDC MISPERCEPTION

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INTERNET APPLICATIONS FOR TOMORROW’S CLINICAL TRIAL

THE “eCLINICAL TRIAL”

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eCLINICAL TRIAL

A clinical trial in which primarily electronic processes are used to collect (acquire), access,

exchange and archive data and documents required for conduct, management, analysis and reporting of

the trial

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THE REAL BENEFITS OF AN eCLINICAL TRIAL APPROACH

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Creating a more efficient and streamlined study management process and removing “paper” redundancies

are indeed enormous measurable benefits

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But there are other intangible benefits of eClinical trial that are not easily transparent and often difficult to measure which can be the most advantageous to the

sponsor and CRO clinical study team

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•Dynamic site management

• Transparency

•Centralized study randomization

•Effective trial drug supply management

•Dynamic program management

•Better planning

•Less frequent site visits

•Shared documents file

•Continuous collaboration

•Real time safety evaluation

•Fast fail decisions

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DYNAMIC SITE MANAGEMENT

Problems with data quality captured at investigative sites, whether due to ineffective site training, poorly designed case report forms or inattentive site personnel, can be identified and resolved quickly, eliminating many errors downstream In a paper trial, repetitive errors build up over time because of the time lag between data entry and data validation/review.

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In eClinical processes, automatic queries provide instantaneous corrective feedback to sites

Clinical monitors have a continuous window into site data entry practices enabling them to intervene quickly before a small issues becomes a major problem

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TRANSPARENCY

One of the most overlooked benefits to an eClinical trial utilizing real time data capture and reporting is that the sponsor for the first time has the ability to measure their vendor’s (i.e. eCRO and participating sites) performance online in real time With information management tools, every site contact report, monitoring visit, and patient enrollment metric is available 24/7 from virtually anywhere in the world through an Internet connection

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TRANSPARENCY

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CENTRALIZED STUDY RANDOMIZATION

The e-randomization procedure will prevent the incorrect enrollment, into the study, of patients not fulfilling all the inclusion and exclusion criteria. Therefore less patients are needed to reach the calculated sample size required for the per-protocol analysis

Ultimately this will ensure reduced timelines and costs

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CENTRALIZED STUDY RANDOMIZATION

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EFFECTIVE TRIAL DRUG SUPPLY MANAGEMENT

Assigning the randomization code and the appropriate “Trial Drug Kit”, the system automatically update the “Drug Distribution Process” and activate, if the case,

the order of new supplies to investigational sites

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DYNAMIC PROJECT MANAGEMENT

Real time tracking of patient enrollment can help control trial size The continuous evaluation of screening results will help to determine whether protocol modifications may be required, such as inclusion/exclusion criteria

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DYNAMIC PROJECT MANAGEMENT

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BETTER PLANNING

Earlier acces to better information allows to take an informed look at the next stages of the development program

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LESS FREQUENT SITE VISITS

In an eClinical trial environment, monitors review data inhouse between site visits. This ongoing review facilitates interaction/communication with site personnel and leads to dynamic site management

Because ongoing data review is being performed, CRAs can visit sites less frequently saving on travel expenses as well

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When visits are scheduled, actual monitoring time is used more efficiently and customized per site

Surprises at the eClinical sites are virtually eliminated, and reducing CRA travel improves staff retention and productivity

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SHARE DOCUMENTS FILE

eTrial Master File must be accessed by the CRO study team as well as by the Sponsor and the Investigators.

Documents collection metrics (i.e. time to … or number of documents available etc) must be used as performance indicators for both CRAs and Investigators

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SHARE DOCUMENTS FILE

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CONTINUOUS COLLABORATION

With eClinical trial, a study team is now unified by a common information set and the entire clinical team- sponsor, CRO and sites- can base decisions on accessible, real time, accurate information

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REAL TIME SAFETY EVALUATION

Because study data is received in real time, potential safety issues can be evaluated and appropriate courses of action determined quickly

This allows for improved patient safety while also enabling quicker go-no go decisions based on safety issues that may arise

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FAST FAIL DECISIONS

With better and faster efficacy and safety information is possible to make more informed go-no go decisions

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CONCLUDING COMMENTS

As illustrated by the development of recruitment, electronic data capture, monitoring, patient education, project management, documents and data management

applications, the Internet is becoming an inportant feature of today’s clinical trial paradigm

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CONCLUDING COMMENTS cont’d

For the Internet’s full potential of efficiency and quality improvement to be realized, there is a need for:

- a more comprehensive appreciation of clinical trial activities (i.e. the eClinical approach with an integrated e-environment monitoring all the study related processes)- a commitment to data quality/regulatory requirements- universal attention to the development of standards (ICH/CDISC/HL7)

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CONCLUDING COMMENTS cont’d

The CRO must understand the value and benefits of the adoption of EDC technologies, and must be

prepared to enforce effective new workflow in order to avoid the improper addition of tehcnology costs onto

paper instead of logically eliminating redundancy

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Thanks for your attention!

1 EDC: THE EXPERIENCE OF A CRO. 2 INTRODUCTION Expenditure on research and development by...

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