Leveraging Real-World Data in Research and FDA Approval Applications

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The US Food and Drug Administration (FDA) has increasingly encouraged drug developers to use real-world data (RWD) and the real-world evidence (RWE) generated from it in applications. As a result, more and more companies are using RWD and RWE in novel clinical trial designs, applications to extend indications, and in post-approval studies.

According to Karen Ooms, “With respect to clinical trials, the FDA notes explicitly that it is important to distinguish between the trial designs and studies that will be covered by the RWE program. Under the FDA’s program, evidence from traditional clinical trials will not be considered RWE. However, hybrid or pragmatic trial designs and observational studies could generate RWE. The FDA’s RWE program will cover clinical trials that generate RWE in some capacity (that is, sources other than traditional trials) and observational studies.”

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(Source: The Medicine Maker, March 9^th, 2023)