EDC: THE EXPERIENCE OF A CRO

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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 RD 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 Internetin 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 RDa)
  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 TODAYS 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 E-CLINICAL TECHNOLOGY MARKET

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

• FDA support for CDISCs data submission
  standards has added credibility
• Investment capital continues to flow into the
  eClinical market at a significant level

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THE E-CLINICAL TECHNOLOGY MARKET

• 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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THE E-CLINICAL TECHNOLOGY MARKET

• 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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WHAT INFORMATION EXISTS PROVING THE VALUE
PROPOSITION OF EDC?

• The three most important criteria to improve in
  any product development effort are
• QualityTime Cost

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WHAT INFORMATION EXISTS PROVING THE VALUE
PROPOSITION OF EDC?

• 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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ITEMIZATION OF EFFICIENCIES AND ADVANTAGES OF EDC
OVER TRADITIONAL MANUAL METHODS
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EDC vs PAPER COST COMPARISON
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EDC IN CLINICAL TRIALS International
experienceAREAS 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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EDC IN CLINICAL TRIALS International
experienceAREAS OF COSTS SAVINGS

• 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

Source www.targethealth.com
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EDC IN CLINICAL TRIALS International
experienceAREAS OF COSTS SAVINGS

• 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

Source www.targethealth.com
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EDC IN CLINICAL TRIALS International
experienceAREAS OF COSTS SAVINGS

• 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
Source www.targethealth.com
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EDC IN CLINICAL TRIALS International
experienceAREAS OF COSTS SAVINGS

• 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

Source www.targethealth.com
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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 ofNew 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 TOMORROWS 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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THE REAL BENEFITS OF AN eCLINICAL TRIAL APPROACH

• Creating a more efficient and streamlined study
  management process and removing paper
  redundancies are indeed enormous measurable
  benefits

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THE REAL BENEFITS OF AN eCLINICAL TRIAL APPROACH

• 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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THE REAL BENEFITS OF AN eCLINICAL TRIAL APPROACH

• 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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DYNAMIC SITE MANAGEMENT

• In eClinical processes, automatic queries
  provide instantaneous corrective feedback to
  sitesClinical 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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DYNAMIC SITE MANAGEMENT
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DYNAMIC SITE MANAGEMENT
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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 vendors
  (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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EFFECTIVE TRIAL DRUG SUPPLY MANAGEMENT
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EFFECTIVE TRIAL DRUG SUPPLY MANAGEMENT
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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/communicati
  on 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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LESS FREQUENT SITE VISITS

• 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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LESS FREQUENT SITE VISITS

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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 todays clinical trial
  paradigm

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CONCLUDING COMMENTS contd

• For the Internets 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 contd

• 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!