EDC at the Tipping Point: How Your Company Should Make the Transition

Institutional barriers to electronic data capture (EDC) are falling away as the pharmaceutical industry is increasingly coming to recognize the benefits of retiring paper trials forever. But there is still a lot of work ahead for individual companies in adopting this more efficient system, experts say.

“The tipping point is near ... 2006 will be a big year for EDC” and its vendors, Phoenix Data Systems CEO William Claypool told PIR recently. Once companies get a taste of having their clinical trial data captured accurately and in real time with EDC, they won’t want to go back, he added.

But widespread EDC adoption will not happen overnight, Claypool and other experts agree. With industry estimates showing that just 15 percent of clinical trials conducted today utilize EDC, the market has a lot of room for upward growth.

Set Clear Goals Early

For firms still considering EDC, Claypool advises having clear metrics and articulating goals in advance. Once you make the strategic decision to adopt EDC, be sure to commit your organization in a meaningful way, he said. Echoing comments from other experts, Claypool noted that the most successful EDC adoptions tend to come from organizations that dive right in compared to those that adopt it in smaller, piecemeal pilot projects. “Jumping around, that modality of constant piloting ... those are the companies that tend to fail [in EDC implementation],” he said.

The first EDC project is usually the toughest. “We’ve found that your most difficult EDC trial is your first one,” Claypool said.

Many companies struggle with Phase I trials and adoption of EDC appears to be happening faster in Phase II, III and IV trials, he said. That’s probably because regulatory requirements aren’t as rigid for Phase I trials, he said, adding that investigator-initiated trials are also slowed by more stringent FDA mandates.

Based on his track record working with a number of drug and device firms leveraging EDC in clinical trials, Claypool said the problem areas tend to revolve around managing eclinical implementations, integrating edata into operations and providing “clean” databases to regulatory agencies. Those problems can usually be addressed through better employee training and skillful use of outside vendors.

For firms considering EDC for a Phase I trial, Claypool advised seeking out vendors who have a proven track record in being flexible. Being able to move quickly and adapt in small and rapid Phase I trials is critical, he stressed.

Costs Won’t Fall

The benefits of EDC on the operations side are clear, most experts agree. But there’s still debate about whether the expense of EDC setup is cost-effective compared to a hybrid paper system. “To [contend] that paper is better than EDC in terms of process is difficult, but the economic argument is still made,” acknowledged Claypool.

And while technology costs have a history of falling as more people adopt them, don’t hold your breath waiting for EDC costs to drop significantly, Claypool warned.

Citing the CRO industry as a parallel cost model, he noted that the “lion’s share” of EDC costs are and should be on the service, not the technology, side. While technology costs may go down, service costs probably won’t, he said. They “haven’t gone down much, if at all, in the CRO industry,” he noted.

Phoenix Data Systems just expanded its own eClinical Data Management services for Phase I-IV trials. For more information, go to http://www.phoenixdatasystems.net/. — Michael Causey