Randomized, controlled clinical trials (RCTs) have traditionally served as the gold standard for evidence generation in support of medical product development and approval. However, it is increasingly recognized that RCTs have inherent limitations. This three-part workshop series provided a venue to examine the practicalities of collecting real-world data and deriving real-world evidence for evaluation of medical products. The workshop was convened by the Forum on Drug Discovery, Development, and Translation, and sponsored by the Food and Drug Administration.

Please visit the individual event pages (1-Incentives, 2-Practical Approaches, 3-Application) for workshop information & materials, and journal articles inspired the by series.