FDA to Support Potential Use of Real-World Data to Generate Real-World Evidence for Regulatory Decision-Making

A new funding opportunity from FDA has been established for projects to further promote the potential use of real-world data (RWD) to generate real-world evidence (RWE) related to drug development. FDA hopes to encourage more projects that address these types of gaps in knowledge that can limit the use of RWD and RWE.

The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation. FDA encourages a variety of projects that are applicable to drugs and biologics, excluding devices.

To further meet the requirements of the 21st Century Cures Act, FDA developed an RWE Program and subsequently published an RWE Framework and as a series of RWD/RWE draft guidance documents about the use of RWE to assist a new indication for an approved drug or to satisfy post-approval study requirements.

In addition, FDA funded various demonstration projects involving external collaboration and engagements, including four U01 awards in 2020 that analyzed the use of RWD and RWE. The projects are almost complete, and the announcement of this recent funding opportunity emphasizes FDA’s efforts to continue to encourage innovative approaches and improved understanding of RWD and RWE.

Source: FDA Announces New Funding Opportunity to Support the Potential Use of Real-World Data to Generate Real-World Evidence for Regulatory Decision-Making, Press Release, Dec. 15, 2022