Advantages of EDC Systems

In principle, EDC systems can provide the sponsor with more rapid access to study results and, by providing continuous monitoring of data, decrease the volume of study data queries, resulting in reduced study costs, less frustration at the study sites, and more rapid data lock when compared with paper-based systems. Although extravagant claims have been made about the increased efficiency of EDC-based trials, the results to date have been mixed. It is clear that to incorporate EDC technology efficiently into trial systems, sponsors must adapt their procedures and department organizations to accommodate the IT support and the changes in staff roles. In some cases, it may be that the database itself becomes the source document (e.g., patient diary data uploaded through a browser with associated patient electronic signature). However, in most cases, just as with paper CRF submission, site visits to monitor protocol compliance and verification of data will still be required.

A major issue for manufacturers and contract research organizations is the acceptability of EDC systems by FDA-reviewing divisions. This point has been discussed in a variety of forums; agency spokespersons have not raised particular concerns, but have noted that any EDC system used must meet the requirements of the agency's guidance document for Computerized Systems Used in Clinical Trials (2). However, as this chapter is written, no marketing applications have been submitted to the FDA in which pivotal trials employing a strict EDC-based process of data collection were included. This may be attributable to industry caution when it comes to incorporating new technology into the high-stakes marketing application process, more than it reflects on the immaturity of EDC technology.

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