FDA must be cautious about using EHRs for clinical trials

People often lump together all of the federal government as one great big entity.  

But the different offices of the executive branch don't always work in lock step. They may not even know what's going on within the same federal agency.

For instance, the U.S. Food and Drug Administration (FDA), evidently frustrated by the lack of clinical drug trials using eSource technology, despite issuing guidance on it almost two years ago, is spearheading an effort for drug trials to incorporate electronic health record data into the research, issuing a notice outlining its intent and looking for demonstration project proposals. Ron Fitzmartin, a senior advisor for the Data Standards Program of FDA's Center for Drug Evaluation and Research's Office of Strategic Programs, explained in a webinar July 7 that "we're very eager to see paper going away. Technologies exist where they have transformational change. We want to encourage and be a part of that."    

Fitzmartin added that the FDA was "technology agnostic," but that it wanted companies to implement new technologies to implement the eSource guidance, and that EHRs would fit with FDA regulation, since they were certified by the government. The FDA "expected the floodgate to open."

This sounds like a great development. EHRs have already demonstrated that they improve and simplify clinical trials. The FDA has been criticized for its slow process of approving new drugs; this could streamline clinical research, bring drugs to market faster and have a major impact on patient health.

But is the FDA aware that EHRs are not a panacea?

For instance, lack of interoperability is already casting a shadow on the usefulness of EHRs in clinical trials.

On top of that, certification of EHR products is now a major concern, and the rallying cry to decertify errant EHRs is growing. Congress has urged the Office of the National Coordinator for Health IT to use its authority to certify only EHRs that meet Meaningful Use and don't block data sharing, and to punish the noncompliant with decertification. Two products were decertified in 2013, and ONC has acknowledged that more widespread decertification is a possibility. If this begins to occur, and EHRs are integral components of clinical trial research, then decertification would not only be devastating to providers using the now-decertified systems, it could adversely affect clinical trials using them, as well.

It has already been discovered that a number of EHRs are not meeting the Meaningful Use certification requirements on usability reporting. This may be just the tip of the iceberg, with the certification of many EHR products suspect and subject to scrutiny.    

Then there's the U.S. Department of Health and Human Services Office of Inspector General (OIG), which has long expressed concerns about EHR fraud and the integrity of EHR data. There's unfortunately ample evidence that EHR data is both inadvertently and intentionally manipulated and compromised. One of the reasons that the FDA wants to turn from paper to EHRs is to improve the integrity of the data used in clinical trials. But is that data truly reliable? Or simply more reliable than paper?

All three agencies--FDA, ONC and OIG--are part of HHS. But you wouldn't necessarily know that by these developments. I'd like to think that the FDA is aware of them, but I haven't seen evidence of that.

Exploring the use of EHRs to improve clinical trials is a wonderful idea. But the FDA should keep an eye on what its colleagues are worried about. Issues elsewhere may put a crimp into its efforts and undermine what the agency is trying to achieve. - Marla (@MarlaHirsch and @FierceHealthIT)

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