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Novel clinical trial designs and statistical methods in the era of precision medicine

Tuesday, June 30, 2020 - 4:30pm

Speaker:   Michael Sklar, Stanford Statistics

Abstract:   We begin with FDA's Guidance for Industry on (a) Master Protocols for Efficient Clinical Trial Designs to Expedite Development of Oncology Drugs and Biologics in 2018; (b) Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products in March 2019; and (c) Adaptive Designs for Clinical Trials of Drugs and Biologics in November 2019. We then describe their biostatistical and biopharmaceutical underpinnings, focusing on recent advancements in adaptive group sequential trial designs and statistical methods for their analysis, and conclude with challenges and opportunities for statistical science in precision medicine and regulatory submission.

This is joint work with Tze Lai and Nikolas Weissmueller.