How Does RWE Impact Clinical Trials?

Explore the growing impact of Real-World Evidence (RWE) on clinical trials, particularly in rare disease research. RWE is derived from Real-World Data (RWD), such as electronic health records, patient registries, and health apps, offering insights beyond traditional clinical trials. It helps overcome challenges like small patient populations and provides a broader understanding of a therapy’s safety and effectiveness. Natural history studies, a type of RWD, are highlighted for their role in characterizing disease progression and informing trial design. While RWE use remains modest, regulatory agencies like the FDA and EMA are expanding its role through initiatives such as the FDA’s Center for Real-World Evidence Innovation and EMA’s DARWIN EU. Challenges include data integration issues, bias, and statistical complexity, but advanced analytical methods can mitigate these. Veristat supports sponsors in leveraging RWE by accessing various data sources and aligning with regulatory expectations to enhance drug development strategies.