Opening Remarks and Background

In her opening remarks on September 23, 2025, FDA Commissioner Sara Brenner emphasized that the use of real‑world evidence (RWE) is rapidly gaining prominence. Traditional clinical trial data alone often cannot capture the full spectrum of patient populations, positioning RWE as a valuable alternative. The urgency for regulators to validate data reliability gives this announcement particular significance.

Success Stories

The number of FDA approvals based on RWE is increasing. Electronic health records (EHR) and insurance claim data collected from real‑world clinical settings have been employed to demonstrate the efficacy of new therapeutics. These successes illustrate shortened development timelines and cost reductions, attracting attention from investors and industry alike.

Challenges and Limitations

Data quality and standardization remain major obstacles. Ensuring consistency across datasets gathered from diverse healthcare providers is difficult, often prompting additional verification during regulatory review. Moreover, safeguarding patient privacy and securing data accessibility continue to be critical concerns.

Lessons Learned and Future Direction

The FDA announced its commitment to continuously update RWE guidance. When transparent data management and proactive engagement frameworks are established, RWE can serve as a powerful complement to traditional clinical trials. The industry should collaborate with regulators early in the development process to formulate robust data strategies.