Clinical Trial EDC Usage Will Continue its Climb, Expert Says

The momentum for electronic data capture (EDC) usage in clinical trials is now beyond the tipping point and should continue to speed up, says Anthony Costello, vice president of Nextrials.

“I predict by the end of 2006 nearly half of all clinical trials will be done with EDC,” he told PIR Sept. 8. “Adoption is starting to accelerate quite quickly.”

As an EDC vendor, Costello says he has noticed a shift in the past several years. Clinical trial sponsors today are more likely to be seeking EDC vendors to which they can eventually shift all their clinical trials.

Contrast With the Past

That contrasts with a few years ago, Costello said, when sponsors tended to want EDC vendors to conduct one-time relatively low-risk Phase I trials only.

He also said that a common knock against EDC — its slow start-up time — is something of a myth. “It’s a proxy for the real problem at some companies, which is as they shift from paper to electronic, they have to make big changes to many [standard operating procedures],” he said.

Some drug and device companies, especially smaller firms engaged in more complicated trials, have expressed frustration with EDC’s slower start-up time versus paper. Large drug manufacturers continue to be the big drivers behind the broadest EDC initiatives, as evidenced by several presentations at the June DIA conference in Philadelphia (PIR, Aug. 2).

EDC continues to face something of an uphill struggle when it comes to acceptance among smaller and even some midsized drug and device companies, experts have told PIR. But any high-profile success with the technology enjoyed by the industry’s biggest players will push others to speed EDC adoption, vendors hope.