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Abstract:
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Master protocols have received great attention in recent oncology drug development. With a single master protocol, multiple treatments or combination therapies for one indication, or one treatment for multiple indications can be evaluated simultaneously. They may allow for adding new treatments, dropping treatments for futility, declaring superior treatments, updating control treatment to be compared during a trial. While the innovative features of master protocols can potentially improve the efficiency of drug development both operationally and financially, statistical issues associated with master protocols are also becoming apparent. In September 2018, FDA circulated a draft Guidance document, ‘‘Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics’’, for public comments. This draft guidance is aimed to facilitate the sponsors using master protocol approaches to streamline mid- to late-phase oncology drug development. In this talk, we will focus on the design considerations, statistical and operational challenges for master protocols in oncology studies from the regulatory perspective.
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