Electronic data capture (EDC) is now used in 58% of clinical trials compared with just 13% eight years ago, according to preliminary findings from a recent international survey of investigational sites.
However, the survey also identified some growing problems with EDC, such as heavier workloads at trial sites and extensive duplication of data input. The use of paper case report forms alongside EDC had actually increased since 2001.
The survey of ‘Investigational Site Perspectives on Clinical Trial Information Systems’ was the first update on the subject since 2001. It was conducted by the eClinical Forum, a not-for-profit association comprising representatives from the pharmaceutical and allied industries, with support from industry associations and from TechTeam Global, a US-based provider of IT and business process outsourcing services.
In the preliminary results based on 629 fully completed responses, 95% of respondents reporting having experience with EDC over the past three years, compared with 52% in the 2001 survey. Moreover, 21% said EDC was used in all of their current clinical trials, versus fewer than 1% in 2001.
While 67% of those surveyed were satisfied with EDC, the preliminary results also indicated a shift away from electronic data capture as a positive factor in an investigational site’s decision to participate in a clinical trial. Nearly 50% of respondents felt their workload had increased when using EDC, which was double the number reporting a heavier workload in the 2001 survey.
The respondents identified speed of system response, cross-system standardisation, resources available for data entry, and help-desk support as among the most important factors that would boost user satisfaction with EDC.
The survey remained open until 30 November and a final report will be released to eClinical Forum members next January. It will be available to the general public via the eClinical Forum and TechTeam Global websites in mid-2010.
