Abstract:
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The American Statistical Association (ASA) oncology working group was chartered in 2019 to explore innovative statistical topics in oncology drug development and a sub-team on master protocol was formed subsequently. In this sub-team, leaders across the industry, academia and regulatory join their experiences regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overarching trial structure, known as a master protocol. More specifically, views on best practices in designing and implementing such complex trials are shared and confirmed; experiences on strategic engagements with world-wide regulators and their feedbacks are exchanged and compiled; various statistical methods that allow borrowing information within the trial and best utilizing the data are reviewed and evaluated. This presentation will provide an update with respect to the above-mentioned aspects.
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