Last week, FDA announced that it will provide a grant of up to $1 million for the use of electronic health record data to determine the safety of drugs after they have reached the market, Clinical Innovation & Technology reports (Walsh, Clinical Innovation & Technology, 4/21).
FDA intends for the grant recipient to turn large amounts of EHR data from the agency’s Mini-Sentinel project into figures that can be used to continuously assess the risks and benefits of postmarket drugs and determine clear safety trends (FDANews, 4/21).
FDA in December 2014 announced plans to create a database through the Mini-Sentinel program, a pilot project of FDA’s Sentinel surveillance system. The program used EHR and claims data to monitor the safety of medical products regulated by the agency. Eighteen large U.S. health care groups — including Aetna, Humana and Kaiser Permanente — served as data partners for the pilot program (iHealthBeat, 1/5). The program helped to create an EHR database with access to more than 150 million patient EHRs, called the Sentinel Distributed Database (FDA grant notice, 4/15).
Additional Grant Details
FDA said that the grant recipient should aim to use the EHR data while also being aware of the information’s limitations and accounting for observational studies’ biases (FDANews, 4/21).
The agency has limited eligibility of the grant to the Reagan-Udall Foundation’s Innovations in Medical Evidence Development and Surveillance-Methods program.
