Most pharmaceutical companies are now employing electronic data capture (EDC) to some degree in their clinical development programmes, even if the technology has not yet achieved routine use in the majority of trials.
At the same time, the emphasis of the EDC market is shifting from technology selection to management issues and operational performance, according to a survey conducted by US company Phoenix Data Systems (PDS) in association with the pharmaceutical publication PharmaVOICE.
PDS, which calls itself the leading provider of full-service electronic data capture solutions, sought the opinions of more than 6,000 clinical professionals in the pharmaceutical, biotechnology and biopharmaceutical/biologics industries on a variety of issues related to EDC, clinical trials and other e-clinical technologies.
Catching on
It found that the EDC habit is still catching on, with 24.5% of respondents saying use of the technology in all of their clinical studies had risen by more than 50% over the last two years. Moreover, 45.2% of the respondents expected their EDC use to increase by more than 50% over the next two years.
EDC also emerged as the e-clinical application with the highest penetration in the companies polled. Among the survey respondents, 83% said their organisation currently employed electronic data capture while 64% confirmed use of integrated voice response systems, 58% clinical data management systems and 54% clinical trials management systems (respondents could select as many options as were applicable).
Asked about the biggest advantages of EDC, respondents – who were allowed to choose up to three – put speed first (73.5%), followed by insight on study progress/results (64.5%), accuracy (54.8%) and reinforcement of best practices (19.4%). They ranked ease of use as the most important criterion in deciding to use EDC in clinical trials, followed by study build and support services; vendor experience; technology architecture; and technology integration.
A ‘market shift’
PDS linked these results to another survey finding, that around 50% of respondents considered EDC more attractive as an outsourced service than a technology-only offering. Together, the responses suggested an important market shift, said the company’s chief executive officer Dr William Claypool.
“Sponsors are increasing their focus on management issues and results, instead of technology selection,” he commented, adding that most vendors were approaching the market with a technology proposition and most clinical outsourcing companies still had not committed to optimising their delivery by leveraging e-clinical efficiencies.
“As e-clinical studies become more mainstream, selection criteria will shift to place more emphasis on operational performance and deployment experience,” Claypool predicted. “When you’re managing a large number of e-linical trials, usability for the site matters.”
