The US Food and Drug Administration (FDA) has released its final guidance on “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” This focus on real-world data (RWD) and real-world evidence (RWE) reflects the agency’s shift towards using practical, real-life data to underpin its decision-making process.
According to a report by Latham & Watkins LLP, the RWD/RWE Guidance finalizes a draft guidance of the same name, and provides regulatory considerations for products used under the Emergency Use Authorization. It also facilitates the use of patient-level data sourced from third parties.
This move potentially affords the pharmaceutical industry greater scope to employ RWD/RWE in order to ensure improved efficiency and valuation in drug development pipelines. It focuses on actual usage and health outcomes, which is particularly useful in scenarios where randomized clinical trials may be unfeasible.
While the use of RWD and RWE in regulatory decisions has potential to streamline drug development— that potential is balanced by the need for precise data collection, robust methodologies and stringent validation processes to ensure the quality and veracity of the RWE being used.
The implications of this final guidance on the pharmaceutical industry are potentially profound. This new approach by the FDA is designed to allow for more flexible and efficient processes while placing an even greater emphasis on data quality and accuracy.