The large and growing number of patients covered by the US FDA’s Sentinel electronic data network is one unique advantage it offers drug sponsors looking to satisfy postmarket safety requirements using real world data, Pfizer Inc.VP Epidemiology Robert Reynolds told the ninth annual Sentinel public workshop.
Reynolds appeared at the Feb. 2 meeting in Washington, DC, as an advocate for using of the agency’s data network based on Pfizer’s participation in a pilot project, completed in 2016, that tested approaches to conducting post-market research in Sentinel. Pfizer collaborated on the project with the Reagan-Udall Foundation for FDA’s Innovation in Medical Evidence Development and Surveillance (IMEDS) program