New Survey Shows Substantial Growth And Some Challenges With Electronic Data Capture In Clinical Trials

Main Category: IT / Internet / E-mail
Also Included In: Clinical Trials / Drug Trials
Article Date: 20 Oct 2009 - 1:00 PDT

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Preliminary findings from a new survey on electronic data capture (EDC) use in clinical trials were presented at the Drug Information Association's (DIA) 3rd Annual Clinical Forum in Nice, France. The survey, titled "Investigational Site Perspectives on Clinical Trial Information Systems," is the first update to a 2001 survey published on the topic.

The eClinical Forum, a not-for-profit association comprised of representatives from pharmaceutical and allied industries, conducted the survey with support from TechTeam Global (Nasdaq: TEAM) and other industry associations. Some key findings from the survey include:

-- Substantial growth in overall use of EDC

Across the surveyed population, EDC is now used in 58 percent of clinical trials versus 13 percent in 2001. Ninety-five percent of respondents indicated that they have had experience with EDC during the last three years versus 52 percent in 2001. And, 27 percent of respondents indicated that EDC is used in all of their current trials versus less than one percent in 2001.

-- Users generally satisfied with EDC, but opportunity for improvement

Sixty-seven percent of those surveyed are satisfied with EDC, however, results also showed a shift away from EDC as a positive factor in a site's decision to participate in a clinical trial. Nearly fifty percent of respondents also perceived an increase in workload when using EDC, which is double the number reported in the 2001 survey.

-- Duplication of data entry

The findings reveal that there is still extensive duplication in data input and that the use of paper case report forms (CRFs) alongside EDC has actually grown since 2001. Ninety percent of respondents indicated that more than 80 percent of their clinical trial data is subject to duplicate entry.

-- How to increase user satisfaction

Respondents identified speed of system response, cross-system standardization, resources available for data entry and help desk support as among the most important opportunities for increasing user satisfaction with EDC.

"As health care and pharmaceutical technologies become more interdependent at the clinical research interface, the eClinical paradigm needs to be revisited in order to respond to advances and external influences," said Richard Perkins, president of the eClinical Forum. "Understanding investigational site personnel's experiences with today's clinical trial technologies, and their perspectives on future requirements, is critical to delivering improved eClinical solutions."

"TechTeam is committed to supporting the effective use of clinical trial technology in the life sciences industry and is thus pleased to help the eClinical Forum conduct this important study," said Chris Donohue, general manager of TechTeam Global's life sciences business unit. "Information from this study will be of significant value to all involved in the clinical trial domain and will help TechTeam improve its services in support of eClinical trials."

About the Survey

The survey, "Investigational Site Perspectives on Clinical Trial Information Systems," was conducted by the eClinical Forum (eCF) to identify site needs associated with electronic data capture (EDC) used in clinical trials. The survey was conducted online via the eCF and TechTeam Global Web sites. Invitations to participate were distributed by eCF members and other industry associations including Data Management Biomedical (DMB), Association for Clinical Data Management (ACDM), ARCS Australia Ltd and Der Fachverband fur Berufstatige in der Medizinischen Dokumentation (DVMD). Preliminary results released are based on the 629 fully completed responses that were received as of September 1, 2009, but the survey will remain open until November 30, 2009 to allow for the collection of additional responses producing a larger sample size for subgroup analysis. Professor Dr. Paul Gemmel from the University of Ghent, Department of Management, supervised the survey and validated its methodology and statistical relevance.

Source: TechTeam Global, Inc

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