FDA Guidance for Adding EHR Data to Investigation Studies

The FDA has been looking for ways to include “real world” data in its “methodological repertoire” to clinical studies for some time.

On July 18, 2018, the agency issued guidance which, it hopes, will facilitate the use of electronic health record (EHR) data in clinical investigations. The idea is to integrate routine care data clinical trials.

Mining Electronic Health Records

The agency says EHRs have valuable data which may be useful to clinical investigators. Such data would include clinical notes, physician orders, radiology, laboratory, and pharmacy records and if combined, aggregated, and analyzed could prove useful.

The FDA’s guidance document is titled, “Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry.”

It is intended to help sponsors, clinical investigators, contract research organizations (CROs), institutional review boards (IRBs), and other interested parties use EHR data in their FDA-regulated clinical investigations.

Their goals, say the agency, “are to modernize and streamline clinical investigations through the use of EHR data and the inclusion of real world data in clinical investigations.”

How this will “streamline” clinical investigation will be interesting to see.

The agency also hopes that this document will encourage sponsors and health care organizations to work with EHR and electronic data capture (EDC) system vendors.

After all, who will solve those pesky problems of interoperability and EHR and EDC integration.

This is streamlined?

Jacqueline Corrigan-Curay, M.D., J.D., director of the Office of Medical Policy in the agency’s Center for Drug Evaluation and Research, said, “Every day, health care professionals are updating patients’ electronic health records with data on clinical outcomes resulting from medical interventions used in routine clinical practice.”

“As our experience with new medical products expands, our knowledge about how to best maximize their benefits and minimize potential risks sharpens with each data point we gather. Every clinical use of a product produces data that can help better inform us about its safety and efficacy.”

Specifically, this document is meant to help clinics and researchers:

• Decide whether and how to use EHRs as a source of data in clinical investigations
• Use EHR systems that are interoperable with electronic data capture (EDC) systems in clinical investigations
• Ensure the quality and integrity of EHR data collected and used as electronic source data in clinical

investigations

• Ensure that the use of EHR data collected and used as electronic source data in clinical

investigations meets FDA’s inspection, recordkeeping, and record retention requirements

The guidance does NOT apply to:

• EHR data in postmarketing observational pharmcoepidemiologic studies
• EHR data designed to evaluate feasibility of the trial design or as a recruitment tool for clinical investigations
• Data collected for registries and natural history studies

Guidance Document

Here’s the 15-page guidance document.

Have fun.