FDAnews Drug Daily Bulletin

EXPERT: EDC MAY NOT BE ALL IT SEEMS

May 11, 2006
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It is not yet clear how much time and money electronic data capture (EDC) will save for clinical trials despite its expectations, a veteran of dozens of trials in the U.S. and Canada said.

"The cost savings [of EDC] are not proven," Valerie Paolella, clinical research manager for Cato Research Canada, told attendees at the Association for Clinical Research Professionals (ACRP) in Phoenix. Smaller and early-stage trials may not save any time and may even lose money with EDC, she warned, because EDC's relatively high startup costs do not vary much based on trial size or stage. "The economies of scale" aren't there for small or Phase I trials, she said.

Also, she added, EDC's startup time is longer for most participants versus paper. The main reason is that designing, programming, testing data entry screens and edit checks must be done in advance with EDC before the first subject begins the program. With paper, those tasks can be done over several months as subjects enter the trial.

Sponsors exploring EDC should explore the experience base of their sites, she advised. They should ask about their experiences with EDC and how they have dealt with setup and firewall issues. It can also be useful to talk with sites about electronic case report form (eCRF) connectivity history, she added, and try to arrange for a live connectivity test.