Monday, July 22, 2024

3:30 PM - 5:02 PM

PLENARY HALL (M1 building upper floor)

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Details

There is an urgent need for new methods in the clinical trials arena. Confirmatory clinical trials are often large, slow, expensive, and inflexible. In this setting, the primary challenge is finding innovative designs that are aimed at the evaluation of multiple new therapies under one protocol. By developing feasible and efficient designs that address several primary research questions or hypotheses, the pace of evaluating experimental treatments can be significantly accelerated. One exemplary method for simultaneously testing multiple primary hypotheses is the Multi-Arm Multi-Stage (MAMS) platform randomised trial. In a MAMS platform trial, a master protocol facilitates the evaluation of multiple treatments over time, offering adaptable features like early cessation of treatment accrual due to lack-of-benefit or the incorporation of new treatments during the trial's duration. This session will explore why these designs markedly enhance studies in confirmatory settings. It will utilize ongoing trials such as STAMPEDE in prostate cancer to highlight how these innovative designs have accelerated the assessment of new agents across various disease areas, including COVID-19. Additionally, it will explore statistical methodologies for controlling error rates when adding or dropping arms, as well as for determining statistical power. Crucial topics to be addressed include designing trials that have multiple endpoints, the implications of using non-concurrent control arm patients on the operating characteristics of a platform trial, the availability of relevant software, and the appropriate choice of error rate control (e.g., family-wise error rate, pair-wise error rate, false discovery rate) for a confirmatory trial.

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Presentations

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Chair