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EDC: THE EXPERIENCE OF A CRO

EDC: THE EXPERIENCE OF A CRO. INTRODUCTION. Expenditure on research and development by pharmaceutical industry is increasing worldwide and is currently estimated to be over $45 billion a year.

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EDC: THE EXPERIENCE OF A CRO

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  1. EDC: THE EXPERIENCE OF A CRO

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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 CDISC’s data submission standards has added credibility • Investment capital continues to flow into the eClinical market at a significant level

  11. 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

  12. 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

  13. 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)

  14. WHAT INFORMATION EXISTS PROVING THE VALUE PROPOSITION OF EDC? The three most important criteria to improve in any product development effort are: QualityTime Cost

  15. 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 implicationsThese three “metrics” have all been shown to be significantly impacted through the proper use of EDC

  16. 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)

  17. ITEMIZATION OF EFFICIENCIES AND ADVANTAGES OF EDC OVER TRADITIONAL MANUAL METHODS

  18. EDC vs PAPER: COST COMPARISON

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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)

  25. THE RISK OF EDC MISPERCEPTION

  26. INTERNET APPLICATIONS FOR TOMORROW’S CLINICAL TRIAL THE “eCLINICAL TRIAL”

  27. 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

  28. THE REAL BENEFITS OF AN eCLINICAL TRIAL APPROACH

  29. 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

  30. 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

  31. 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

  32. 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 downstreamIn a paper trial, repetitive errors build up over time because of the time lag between data entry and data validation/review.

  33. 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

  34. DYNAMIC SITE MANAGEMENT

  35. DYNAMIC SITE MANAGEMENT

  36. 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 timeWith 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

  37. TRANSPARENCY

  38. 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

  39. CENTRALIZED STUDY RANDOMIZATION

  40. 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

  41. EFFECTIVE TRIAL DRUG SUPPLY MANAGEMENT

  42. EFFECTIVE TRIAL DRUG SUPPLY MANAGEMENT

  43. DYNAMIC PROJECT MANAGEMENT Real time tracking of patient enrollment can help control trial sizeThe continuous evaluation of screening results will help to determine whether protocol modifications may be required, such as inclusion/exclusion criteria

  44. DYNAMIC PROJECT MANAGEMENT

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

  46. 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

  47. 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

  48. LESS FREQUENT SITE VISITS

  49. 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

  50. SHARE DOCUMENTS FILE

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