Unlocking The Power Of Real-World Evidence In FDA Submissions

Real-world evidence (RWE) has become a significant focus for the FDA and those involved in FDA submissions, and its importance continues to grow. Since the enactment of the Cures Act in 2016, the FDA has actively sought opportunities to leverage real-world data (RWD) and has recognized the significance of RWE. As a result, RWE in regulatory submissions for new products has become increasingly imperative.

RWD is gradually gaining prominence on par with randomized clinical trials (RCTs), which have long been considered the gold standard for generating conclusive evidence. While RCTs are meticulously structured and conducted to meet rigorous clinical criteria, RWD, on the other hand, primarily gathers data to support purposes beyond clinical trials, and historically has often been given less consideration in supporting clinical trials.

However, as data availability continues to grow, it’s become inevitable that the robustness and methodologies inherent in RCTs would be integrated into the ever-increasing volume of RWD being generated daily. Understand the gaps between how data is collected in RWE and RCT, and how RWE is quickly finding ways to catch up: from applying rigor to RWE by reusing data models and repurposing methodologies from RCTS to creating fit-for-purpose methodologies for postmarket surveillance.