I-SPY 2 Helping To Normalize Adaptive Trial Designs

Jul 10 2016

• By Bridget Silverman

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Publication in NEJM of results from Phase II of master protocol study of breast cancer combinations also helps build support for Bayesian statistics.

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Innovations in clinical trial design like adaptive designs based on Bayesian statistics and master protocols have so far produced more enthusiasm than regulatory results, but the publication of data two cohorts from the adaptively randomized I-SPY 2 Phase II trial in the New England Journal of Medicine could go some way toward moving new designs from theory to more widespread practice.

The value of I-SPY 2, a master platform trial designed to screen multiple regimens in combination with standard neoadjuvant chemotherapy...

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