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.”
“This includes ways to expand our methodological repertoire to build on our understanding of medical products throughout their lifecycle—for example, 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,” Corrigan-Curay added.
The guidance does not apply to postmarket surveillance studies, or the use of EHR data as a recruitment tool or to test the feasibility of a trial design.
Michelle Hoiseth, corporate vice president for real-world data services at Parexel, said the agency’s definitions help move the industry toward a necessary common vernacular.
“The guidance on data standards allows industry freedom to invest without risk of ending up with an unacceptable standard,” Hoiseth said. “Guidance on validating interoperability, quality management plans, and handling of software updates is practical and much needed.”
In addition, “identifying the EHR as the originator and clarifying that multiple personnel can input those data critically clarifies related aspects of site monitoring practice.”
The FDA also recommended the use of EHR systems certified through the Office of the National Coordinator for Health IT, which meet certain privacy and security protection requirements.
“Guidance on ONC Health IT Certified EHR sources eliminates degrees of uncertainty in selecting a data source and will help move interoperability forward among data holders who seek to earn revenue from using their data in regulated clinical research,” Hoiseth said. “Overall, a great step in the right direction.”