The FDA recently finalized an eagerly awaited guidance on the incorporation of electronic health records and real-world data into clinical trials and product submissions, including the use of patient medical histories, pharmacy records, radiology scans and lab test results from routine care, including from foreign clinical sites.
While EHR systems themselves are not under the control of the FDA or its regulated entities—and the agency said it does not intend to assess the compliance of EHRs with federal regulations—it still makes clear that its overall acceptance of a submission depends on its ability to verify the quality and integrity of the data.
This means audit trails with identifiable authors and retaining records for as long as required, as well as having policies and processes in place to secure the data, including limiting access to authorized users. In addition, sponsors should consider whether the EHR has any potential to unblind a study.
The guidance (PDF) also urges sponsors, vendors and healthcare organizations to work towards making EHRs interoperable and integrated with clinical studies’ electronic data capture systems—and to ensure that the EHR data collected meets FDA’s inspection and recordkeeping requirements.
Integrated EHR data, in the FDA’s view, can unlock clinical trial efficiency and improve accuracy using real-time data, as well as facilitate long-term follow-up of large numbers of patients.
“Every clinical use of a product produces data that can help better inform us about its safety and efficacy,” said the FDA’s Jacqueline Corrigan-Curay, director of the Office of Medical Policy in Center for Drug Evaluation and Research. “The FDA is committed to developing policies and tools to help researchers access and use data collected from all sources to support a finding of safety and efficacy.”