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The Use of EDC in Canadian Clinical Trials


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Presentation at CHEO Research Rounds on a study to estimate the proportion of Canadian clinical trials that are using an Electronic Data Capture system during the period 2006-2007.

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The Use of EDC in Canadian Clinical Trials

  1. 1. The Use of EDC in Canadian Clinical Trials Khaled El Emam, CHEO RI
  2. 2. Collaborators <ul><li>Paper published in the Journal of Medical Internet Research in March 2009 ( ) </li></ul><ul><li>Co-authored with: </li></ul><ul><ul><li>Elizabeth Jonker, CHEO RI </li></ul></ul><ul><ul><li>Margaret Sampson, CHEO </li></ul></ul><ul><ul><li>Karmela Krleza-Jeric, CIHR </li></ul></ul><ul><ul><li>Angelica Neisa, CHEO RI </li></ul></ul>
  3. 3. <ul><li>There is conflicting evidence about the extent of adoption of EDC </li></ul><ul><li>Practitioners claim a 70% failure rate in the adoption of EDC </li></ul><ul><li>Some evidence of benefits from EDC: </li></ul><ul><ul><li>acceleration of trial start-up </li></ul></ul><ul><ul><li>reduce overall duration of trial </li></ul></ul><ul><ul><li>reduce data errors </li></ul></ul><ul><ul><li>a case can be made for promoting adoption </li></ul></ul>The Problem
  4. 4. <ul><li>Six previous surveys of EDC adoption </li></ul><ul><li>Problems with these surveys: </li></ul><ul><ul><li>imprecise definition of EDC </li></ul></ul><ul><ul><li>none were published in peer-reviewed journals </li></ul></ul><ul><ul><li>sampling and response rates not clear/reported </li></ul></ul><ul><ul><li>unit of measurement unclear </li></ul></ul><ul><ul><li>geographic location of trials unclear </li></ul></ul>Systematic Review
  5. 5. Summary of Evidence - I Year Reported Adoption Rates 2000 12%, 10%, 15% 2001 37% use EDC on 10% to 20% of trials 11% on more than 20% of their trials 2002 17%, 29% 2003 18% 2004 20%
  6. 6. Summary of Evidence - II Year Sponsors CROs 2000 11%, 8% 16%, 11% 2002 24%, 18% 24%, 16% 2003 27% 8% 2004 30% 11%
  7. 7. <ul><li>Estimate the proportion of Canadian trials that use an EDC system for 2006-2007 </li></ul><ul><li>Develop a more precise way of measuring EDC and use of an EDC </li></ul><ul><li>Understand some of the factors that have an impact on adoption: </li></ul><ul><ul><li>Funding source (academic vs. commercial) </li></ul></ul><ul><ul><li>Size (sites and target recruitment) </li></ul></ul><ul><ul><li>Participant type (adult vs. pediatric) </li></ul></ul>Objectives
  8. 8. <ul><li>Because of FDA, journal, and CIHR trial registration requirements, many (most) trials are publicly registered: </li></ul><ul><ul><li> </li></ul></ul><ul><ul><li>Controlled Clinical Trials </li></ul></ul><ul><li>We excluded Phase I trials </li></ul><ul><li>Selected trials had to be on-going during the 2006-2007 </li></ul><ul><li>Selected trials had to have at least one site in Canada </li></ul>Canadian Clinical Trials
  9. 9. Overall Descriptive Summary Summary Characteristic Value Registered trials which met inclusion criteria 947 Median target recruitment 226 Median number of sites (overall) 5 Median % of Canadian sites 100% Largest trial – number of sites 782 Largest trial – target recruitment 35,000 Percentage of academic trials 52.6% Percentage of pediatric trials 9%
  10. 10. Comparison by Funding Source * difference significant at alpha=0.05 Academic (median) Commercial (median) Target recruitment* 130 400 Total sites* 1 39 Canadian sites (%)* 100% 11%
  11. 11. Comparison by Participant Type * difference significant at alpha=0.05 Adult (median) Pediatric (median) Target recruitment* 236 141 Total sites* 6 1 Canadian sites (%)* 57% 100%
  12. 12. Survey Respondents & Responses <ul><li>Focus on Canadian site coordinators, but their contact information is often not included in the registries </li></ul><ul><li>We were able to get study contact information for 716/947 (75.6%) of trials </li></ul><ul><li>We were able to get Canadian site coordinator contacts for 331/716 (46%) of the trials </li></ul><ul><li>Web survey instrument sent to coordinators of the 331 trials, 78% response rate </li></ul><ul><li>No evidence of nonresponse bias, but analysis weighted responses to mitigate for nonresponse </li></ul>
  13. 13. What is an EDC System ? <ul><li>We defined it in terms of a set of features that at a minimum allow trial sites to submit data electronically into the central database and to be able to query that central database for reports and aggregate statistics </li></ul><ul><li>A set of features was obtained from reports comparing EDC systems on the market and the required features according to 21 CFR Part 11 </li></ul>
  14. 14. Measuring EDC Adoption - I Level Feature(s) 1 The system provides a unique account and password for each user to access the on-line system 2 Subject visit data is entered by sites through a web interface into electronic Case Report Forms (eCRFs) The completion status of each eCRF for each subject can be tracked automatically on-line – for example, you can see which visits have complete data and which still have incomplete eCRFs for each subject The system provides an audit trail for all data entry and data modification
  15. 15. Measuring EDC Adoption - II Level Feature(s) 3 Data validation happens automatically when data is entered into the eCRF (either right away or when the user presses the SUBMIT button) – for example, to check for out of range values The system will automatically log the user off after a period of inactivity 4 Subjects are randomized automatically, either through an automated telephone response system or through a web interface 5 Subject recruitment can be tracked on-line for each/your site – for example, the user can see a graph of recruited and not withdrawn subjects over time 6 The system allows tracking of medication inventory at the sites
  16. 16. Main Results <ul><li>41% of Canadian trials used an EDC system (defined as sophistication level > 1) </li></ul><ul><li>Median EDC sophistication level = 4 </li></ul><ul><li>No difference in sophistication of EDC among adopting academic vs. commercial trials </li></ul><ul><li>Adopting pediatric trials tended to use a more sophisticated EDC </li></ul><ul><li>Logistic regression model showed that larger and commercial trials are more likely to adopt an EDC system </li></ul>
  17. 17. Conclusions <ul><li>We are at the steepest point of the adoption curve – in the next couple of years we would expect to see rapid increase in adoption by the rest of the early majority and the late majority </li></ul><ul><li>Implications for: informatics research, adaptive trials, and regulatory submissions </li></ul><ul><li>It takes considerable effort to get summary information about clinical trials in Canada </li></ul>