EDC 'Mild Backlash' No Surprise To Technology Advocate

Electronic data capture (EDC) is temporarily on the downward arc of a predictable acceptance rollercoaster ride, EDC advocate and Nextrials CEO James Rogers told PIR.

As with many new technologies, EDC proponents promised a lot when the technology began to appear in the late 1990s, and in the past year or so some companies have revised or otherwise tempered their enthusiasm for it, Rogers noted. While he remains “pretty bullish” on EDC, he also said he wasn’t surprised to see a “mild backlash” against EDC from some in the industry.

Chalk it up to some early missteps from vendors, the inherent caution of most big pharmaceutical companies and the “typical resistance to new technology,” Rogers suggested.

Hurdles to Overcome

Many drug and device companies recognize the value of EDC but they are also beginning to appreciate some of the “significant hurdles” involved when embracing the technology, Rogers said. For starters, paper trials still hold an edge over EDC when it comes to actually launching the trial, he noted.

But once a trial is up and running EDC’s advantages over paper are clear, he added. Among other things, EDC speeds database lock and provides faster access to cleaner data.

Rogers said he’s hearing FDA-regulated life science companies complaining more about the service around EDC software rather than the technology itself. “I think all packages are pretty stable — they all do the basic things but it really comes down to service and support,” he said. His firm focuses most of its efforts on EDC projects for small and midsized biotech companies.

But while biotech companies tend to embrace EDC as part of their overall entrepreneurial spirit, they often lack the funding to explore the technology as much as they’d like, he noted.

EDC will also provide greater benefits if it can be successfully conjoined with electronic health records (EHRs), Rogers noted. The benefits of linking the two technologies include lowering costs, increased efficiency at trial sites because of lower data-entry requirements, and increased efficiency at sponsor sites because of lower source-data verification needs.

EDC brings to EHRs a consolidation of edata from multiple sources, Rogers noted. It also makes it easier to clean up and analyze edata.

Linking the two is important because EDC on its own is unlikely to evolve into EHR and EHR is unlikely to develop a clinical trial component on its own, he said. In addition, there is currently no dominant EHR or EDC vendor to drive the market. He predicts industry will move toward a hybrid model using middleware that accommodates multiple EHR products and allows companies the freedom to select their EDC vendor.

Part 11 Issues Raised

But EHR must be 21 CFR Part 11 compliant, Rogers stressed. “EHR hasn’t had that requirement and is not terribly motivated to invest in it,” he said. That’s a problem because “it doesn’t do much good to have a compliant EDC system being fed edata by a noncompliant EHR,” he pointed out.

The lack of EHR interest in Part 11 compliance may not change unless and until the FDA shows greater interest in enforcing Part 11 requirements, he suggested. Many in EHR have the attitude of “waiting for FDA to lower their Part 11 standards,” he said.

“What scares the heck out of me is that the FDA has reserved the right of selective enforcement” of Part 11, Rogers said. He’s concerned that if industry doesn’t focus enough on Part 11 compliance, the agency’s compliance “pendulum” will swing back toward tougher enforcement. — Michael Causey