Broken link found in electronic clinical trial startups

Yet another logjam has been exposed in a survey about one of the key steps in launching a clinical study--electronic trial startups. Electronic data capture (EDC) has become the gold standard for collecting data from trials, but building databases and other technical preparations for EDC-supported studies can sometimes take longer than the trials themselves, a company-sponsored survey found.

Count electronic trial startups along with other overly lengthy steps, such as recruitment and study approvals, needed to get a clinical trial off the ground. About 40% of Phase II and Phase III studies required more than 8 weeks to build with EDC systems, according the survey sponsored last year by Cmed Technology. And some complex trials took about half a year to build, according to an eCliniqua article.

U.K.-based Cmed sells software design to streamline electronic trial startups, so the results of the survey buttress the company's case for the product. However, as eCliniqua reports, none of the survey's 87 respondents from pharma, CROs and other clinical research groups were employees or customers of the company. Also, the findings of the study confirmed that even technically savvy trials professionals struggle with the complexity and rigor of electronic trial building.

Electronic data capture, which took off in popularity during the 2000s, solved some of the bottlenecks of paper-based systems, yet brought some new challenges that need to be overcome.

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