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FDA Finalizes Guidance on Use of EHR Data in Clinical Investigations


The FDA has finalized guidance on using electronic health record (EHR) data in clinical trials.

With a nationwide push toward incorporating real-world evidence in decision making, the FDA has finalized guidance on using electronic health record (EHR) data in clinical trials.

The guidance is intended to assist sponsors, clinical investigators, and other stakeholders in using the data for clinical investigations.

“In an effort to modernize and streamline clinical investigations, the goals of the guidance are to facilitate the use of EHR data in clinical investigations and to promote the interoperability of EHR and electronic data capture (EDC) systems,” stated the document.

The final guidance comes 2 years after the FDA announced the availability of the draft guidance. The guidance provides recommendations and best practices for:

  • Deciding whether and how to use EHRs as a source of data in clinical investigations
  • Using EHR systems that are interoperable with EDC systems
  • Ensuring the quality and integrity of EHR data collected and used as electronic source data
  • Ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets the FDA’s inspection, record-keeping, and record-retention requirements.

Based on feedback during the comment period, the final guidance includes clarifications for:

  • The types of clinical investigations that fall under the scope of the guidance
  • Recommendations on the use of EHR and EDC systems that are interoperable or fully integrated
  • Recommendations on the use of certified and noncertified EHR technology
  • How electronic source data principles apply to EHR data used as source data
  • Inspection, recordkeeping, and record retention requirements

Access to real-world data has the potential to support the approval of new indications for already approved drugs, as well as other regulatory decisions based on clinical investigations. During the 2018 American Society of Clinical Oncology Annual Meeting, June 1-5, in Chicago, Illinois, a session discussed the growing role of real-world evidence and how it can be leveraged in combination with clinical trials to inform evidence-based care.

Panelists highlighted some gaps in clinical trials that real-world evidence can fill. They noted that trials are not the optimal fit for questions of application of the innovation to broad and diverse populations and they are not well suited to answer post-hoc questions about differences in efficacy among subgroups or application to populations outside the clinical trials, often due to a small and/or homogenous sample size.

Real-world evidence can address those gaps by providing robust and well-rounded data, they argued.

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