FDA Finalizes Guidelines on Using EHRs in Clinical Trials

FBI and EHR guidelines

New FDA guidelines on electronic health records clear the way for clinical trials to benefit from streamlined patient data.

New technology is transforming the healthcare industry faster than clinical trials have been able to keep up. While research is becoming more efficient and less expensive, the legwork that goes into getting that research off the ground – namely, finding clinical trial patients – still makes up around 30% of study costs.

Fortunately, the technology exists to cut patient recruitment costs and redirect that time and budget into the trials themselves. Electronic health records (EHRs) contain much of the data needed to identify potential trial patients who may not have ever realized clinical trials were an option for their conditions otherwise. Sponsors and CROs have struggled to effectively utilize EHR technologies thus far – but new FDA guidance has the potential to bring EHRs into the mainstream.

The FDA’s Decision on EHRs

In mid-July, the FDA finalized long-awaited guidelines for the incorporation of EHRs into clinical trials, encompassing the use of patient medical histories, pharmacy records, radiology scans and lab test results. While the FDA does not have control of EHR systems themselves, the new guidance makes it clear that EHR submissions must follow a specific set of regulations that assure the quality and integrity of the data.

The first step toward making EHRs interoperable is ensuring consistent vocabulary and record-keeping standards, which the FDA’s inspection and record requirements are intended to regulate. With these standards in place, information exchange between healthcare professionals and clinical trials can become more streamlined, as all parties clearly understand what is and is not acceptable in recording and sharing patient records electronically.

In a statement accompanying the release of the guidance, Director of the Office of Medical Policy in FDA’s Center for Drug Evaluation and Research Jacqueline Corrigan-Curay said, “Every clinical use of a product produces data that can help better inform us about its safety and efficacy. This guidance … facilitates the use of electronic health record data collected in routine care settings into clinical trials.”

What EHR Guidance Means for Clinical Trials

The clinical trial process stands to greatly improve with the implementation of EHR technologies. Currently, 40% of trials fail to meet recruitment goals, even though a large portion of their budgets are funneled directly into patient recruitment.

Fortunately, EHRs present a viable solution for shrinking the gap between recruitment goals and recruitment numbers. Like any other data source, EHRs can be mined for information on patients who may match trial criteria, allowing trials to reach patients who might not have known that clinical trials could help them. In addition, trials can access pharmacy and insurance claim records to find patient leads that don’t meet inclusion criteria more quickly. Finally, EHRs increase the speed of data collection and reporting, auto-populating forms so sites and patients spend less time on paperwork.

Though the incorporation of EHRs into clinical trials can now begin apace, sponsors and CROs can continue to strengthen patient populations through digital marketing. Search and social ads are some of the most cost-efficient means of increasing a trial’s reach, connecting sites with patients who most need to hear from them. With the new FDA guidance, trials stand to recruit more qualified patients more quickly, improving the trial’s chance of success.

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