FDA to focus on data in new ‘top strategic priority’

The US Food and Drug Administration (FDA) has announced a new strategy for the use of “real-world evidence” (RWE) and “real-world data” (RWD) to improve its regulation of new drugs.

In a press release issued yesterday, December 6, FDA commissioner Scott Gottlieb unveiled the Framework for the FDA’s Real-World Evidence Program, describing it as a “top strategic priority”.

RWD is data gathered from a number of sources involving the actual use of a new drug in practice rather than in a research trial setting. Gottlieb said that RWD can in turn be used to develop new information and evidence that can improve regulatory decision-making.

According to the document, the FDA already encourages the use of RWD in the use of traditional clinical trials. The focus of the new strategy will instead be on how these types of data can be used to generate new evidence outside of the scope of clinical trials.

The strategy will prioritise further consideration of the quality of data that can be captured using these sources and how the data can improve the quality of a result. The FDA is seeking to make RWE an “integral part of the drug development and regulatory life cycle at the FDA”.

Gottlieb highlighted that designing traditional post-market research studies is an expensive and lengthy process, often taking a number of years. It is hoped that the use of RWE can deliver information on the efficacy of a drug sooner. According to the statement, RWE “eliminated the need for post-marketing studies” on nine safety issues involving five different products.

The strategy follows the enactment of the 21st Century Cures Act, passed in 2016. The law required the FDA to investigate how RWD and RWE could be used to improve the regulatory process.

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