This short course will provide an overview of the current use of real-world data (RWD) and real-world evidence (RWE) for evidence generation in major markets, with a primary focus on regulatory use and how it can inform clinical development planning. Following the major points from recently released guidance documents from around the world, the course will explain how the fitness of evidence from RWD are assessed for any use case, key elements of design and analysis, and the current status for when real-world studies will be sufficient to meet regulatory evidence requirements. Specifically, the course will discuss (a) the evolving regulatory landscape; (b) the evolution of RWD, how to utilize it, and when RWD is fit-for-purpose; (c) the evolution from safety evaluation to label extensions; and (d) how to ensure design transparency and data feasibility when proposing external comparator arms. The course will feature interactive elements such as polling questions, and participants are encouraged to present their own scenarios for open discussion.
*Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory.
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