Issue Date: March 1, 2022
Issued by: Oncology Center of Excellence
Topic(s): Administrative / Procedural, Pediatric Product Development, Biosimilars
Status: Final
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry
This guidance provides recommendations to sponsors of drugs or biologics for the treatment of cancer 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 overall trial structure (master protocols) in adult and pediatric cancers. In general, the recommended phase 2 dose (RP2D) should have been established for an investigational drug or drugs evaluated in a master protocol.
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