The FDA's draft guidance on EHRs and clinical trials needs more meat

We may finally see more streamlined approval of new drugs and devices, thanks to the U.S. Food and Drug Administration's latest effort to push researchers to use electronic health records in clinical trials--draft guidance published this week regarding how to use EHRs as a source of data.

The FDA has long expressed interest in the use of EHRs in clinical investigations, issuing two related guidances in recent years and expressing its intent to proceed with demonstration projects. The agency acknowledges in the new guidance that EHRs can enable researchers to more easily combine, aggregate and analyze data and conduct follow ups. By the FDA's own acknowledgement, EHRs will "get medicine to market faster."

The document shows that the FDA took a hard look at what the Office of the National Coordinator for Health IT has been wrestling with regarding EHRs, as it incorporated two big issues into the guidance.  

First, the agency makes it clear that researchers should use interoperable EHRs and electronic data capture (EDC) systems to allow for auto population and full integration of the data. The guidance also recommends the use of certified EHR technology, which may be more likely to keep information confidential and reliable. These were two issues we highlighted last year that the FDA needed to address.

Still, the draft guidance is pretty skimpy and raises questions that must be answered.

For instance, the FDA says that sponsors of research "should ensure" that EHRs and the policies and processes for their use provide electronic source data that are "attributable, legible, contemporaneous, original and accurate (ALCOA)." To meet such ends, sponsors are encouraged to include information regarding the intended use of EHR in their protocols, use audit trails, consider whether risks, such as data breaches, should be part of informed consent and consider whether privacy and security safeguards are in place.

But how does the sponsor know if the original data in the EHR is accurate? We know that EHRs are rife with copy-and-paste errors, auto-complete template mistakes and the like. How can a sponsor begin to determine the integrity of the underlying EHR it's relying on? So much of that has nothing to do with certification or interoperability; it instead encompasses data input, user error, computer glitches, design flaws and other problems. We also know that patients are more likely to withhold information when an EHR is used, which also adversely affects the data's accuracy and completeness.

And what about attribution, legibility, contemporaneousness or originality, the other ALCOA elements? The draft guidance doesn't even address those.

Moreover, how should sponsors deal with the providers that control the original data? The guidance acknowledges that the researchers are likely not the owners of the EHRs, but that it's still their responsibility to assess the validity, reliability and integrity of the data. How is the sponsor going to do that? What should the sponsor require of the healthcare provider? What limitations should be placed on the data? For example, the guidance says that EHR updates should not affect the reliability of the data; but what should a researcher do if the provider wants to switch to a brand new EHR system? 

The FDA says that the guidance "clarifies FDA's expectations" regarding the use of EHRs. But it doesn't do so by much. The agency must put more meat on those guidance bones and provide more substance if it really wants to get the EHR clinical trial ball rolling. - Marla (@MarlaHirsch and @FierceHealthIT)

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