All Times EDT
Real-world data (RWD) and real-world evidence (RWE) have traditionally been used in medical product development. Since the passage of the 21st Century Cures Act in 2016, the use of RWD and RWE in product development and regulatory decision has received increased attention. Stein (2019) provides a wide spectrum on the use of RWD and RWE at different stages of clinical trials with different study designs. Recently, the US Food and Drug Administration issued several guidance documents on the use of RWD and RWE to support regulatory decision-making for drugs and biologics. This talk will provide an overview on the use of RWD and RWE in master protocol trials. Specifically, this talk will cover (1) an overview of traditional use of RWD and RWE in clinical trials, (2) some special considerations in using RWD and RWE in master protocol trials, and (3) a roadmap of using RWD and RWE for product development in general, and (4) challenges and opportunities when including RWE in master protocol trials. Illustrative examples are given throughout the presentation.