FDA Announces Funding Opportunity for Real-World Data Research

The U.S. Food and Drug Administration (FDA) is announcing a funding opportunity for projects to support the agency’s understanding of the potential use of real-world data (RWD) to generate real-world evidence (RWE). Through this announcement, the agency hopes to encourage innovative approaches to further explore the use of RWD while making sure that scientific evidence supporting marketing approvals meet our high evidentiary standards. FDA is particularly interested in projects that compare use of RWD and generation of RWE with more traditional approaches and methods for data collection and evidence generation.

The scope of this funding opportunity includes projects that focus on exploring and conducting innovative clinical trials; explaining ways to address challenges to using RWD in research studies; exploring the use of innovative technologies; designing and conducting pilot projects; determining endpoints that RWD can capture; and evaluating reliability considerations around the use of RWD.

As directed by the 21st Century Cures Act, FDA is exploring the potential use of RWD and RWE to support the approval of new indications or post-approval study requirements for approved drugs. In December 2018, FDA published a strategic RWE Framework outlining the RWE program. FDA defines RWD as data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. The agency defines RWE as the clinical evidence about the use and potential benefits or risks of a medical product derived from analysis of RWD.

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