FDA-AACR Workshop Examines the Practice and Promise of Real-world Evidence in Oncology

Building on advances in technology and analytical tools, real-world data (RWD) sources have attracted increasing interest as means to efficiently answer important clinical, research, and regulatory questions around oncology treatments and outcomes. RWD can come from a variety of sources, including medical claims data, electronic health records, patient-reported outcomes, and product or disease registry data. Real-world evidence (RWE) is clinical evidence generated from these data.

While the randomized controlled trial remains the gold standard for gathering clinical evidence for regulatory use, RWE can provide critical insights in situations where such trials may be difficult to complete. This is especially relevant in oncology, where personalized medicine approaches are leading to increasingly smaller patient populations that necessitate new strategies for efficient drug development.

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