July 18, 2018
“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,” said Jacqueline Corrigan-Curay, M.D., J.D., director of the Office of Medical Policy in FDA’s Center for Drug Evaluation and Research. “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. This guidance issued today facilitates the use of electronic health record data in clinical investigations and helps integrate data collected in routine care settings into clinical trials. Harnessing the real-world data being captured in electronic health records enables clinical investigators to collect data from routine medical care and generate scientific evidence that’s appropriate for regulatory decision making and helps generate accurate, science-based information health care professionals and patients need to use medical products to maintain and improve public health.”
Today, the U.S. Food and Drug Administration published a guidance for industry entitled, “Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry.” The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations.
The guidance’s goals are to modernize and streamline clinical investigations through the use of EHR data and the inclusion of real world data in clinical investigations. In addition, the guidance will encourage sponsors and health care organizations to work with EHR and electronic data capture (EDC) system vendors to further advance the interoperability and integration of EHR and EDC systems.
The 21st Century Cures Act requires the FDA to achieve certain deliverables on the use of real world evidence, including a framework for a program to evaluate real world evidence and to issue guidance for industry about the use of real world evidence in regulatory decision making. These activities are informing policy discussions that will ultimately inform guidance on evaluation of real world evidence for supplemental applications and post-approval studies. Issuing the guidance for industry on the use of EHR data in clinical investigations is part of the agency’s commitment to furthering the advancement and usage of new technologies in scientific and regulatory processes.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.