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| home > epc > winter 2001 > the value of e-libraries in edc scale-up scenarios |
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European Pharmaceutical Contractor
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The early adopters implemented electronic data capture (EDC) over 15 years ago. Shortly after, the use of EDC grew to about 10 per cent of all clinical trials.
However, figures based on a recent survey (1) show that the majority of respondents still lack any experience of EDC. The respondents that did have experience with EDC estimated that around 10 per cent of the trials within their organisation were performed using EDC. It seems obvious that paper is still used in the large majority of clinical trials today and scaling up EDC does not seem to be widespread. The creation of a validated e-CRF for a study is a new process which has superseded conducting a study on paper and is now suddenly on the critical path. The construction of an EDC library is of primary importance in scale-up scenarios and can reduce development and validation time, thereby considerably contributing to the success of EDC.
Why Has the Industry Not Embraced EDC Before?
Several presentations and articles have described EDC successes. Some of them have documented that EDC had been cheaper than the paper equivalent in specific trials. Others mainly state the importance of the so-called 'learning organisation', where pilots are the way to reach a company-wide understanding of the process change when integrating a new technology such as EDC within the organisation.
Although pilot projects are a good introduction to EDC, their results cannot always be generalised for all clinical trials. Often the pilot or project has the wrong profile to demonstrate the true value of EDC for the entire organisation, for example:
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By Linda Mook and Frank Zweerus, Directors of Product Management at Araccel
Linda Mook is Director of Product Management at Araccel. She has worked within the clinical trial arena since 1995 after obtaining her MSc in Medical Information Science from the University of Amsterdam. Starting out in clinical data management at the Rotterdam University Hospital, she soon moved to project management and operational management, integrating EDC within large sponsor organisations.
Frank Zweerus is Director of Product Management for Araccel. He has 15 years of experience in computer science and has been responsible for various aspects of implementing EDC projects since 1991. He has been involved in scaling up EDC from single centre Phase I studies, to global Phase III studies with hundreds of sites, as well as integrating EDC into the day-to-day operations of pharmaceutical companies.
Frank and Linda's current responsibilities include the development of the next generation EDC product, that uses the latest technologies, and combines input from fax, scan, remote data entry, and traditional paper-based clinical trials.
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