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23 September 2020

A protocol of a clinical trial with a design that allows testing multiple drugs and/or multiple sub-populations in parallel, is called master protocol. Master protocols have been used in the pharmaceutical industry for some time now and examples include the I-SPY 2 trial and the Lung-MAP trial.
For this webinar, PSI brought together experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies. The speakers recapitulated terminology surrounding master protocols, presented recent advances in the methodological research on master protocols, discussed concerns regarding type I error control and Bayesian approaches, and outlined the operational aspects of running a clinical trial with a master protocol through case studies.

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