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.

1. The Use of EDC in Canadian Clinical Trials Khaled El Emam, CHEO RI

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. Summary of Evidence - II Year Sponsors CROs 2000 11%, 8% 16%, 11% 2002 24%, 18% 24%, 16% 2003 27% 8% 2004 30% 11%

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. 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. 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%

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. 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recruitment can be tracked on-line for each/your site – for example, the user can see a graph of recruited and not withdrawn subjects over time 6 The system allows tracking of medication inventory at the sites