Aug. 11, 2021
8 a.m CT
Robust and reliable decision-making is critically important at any stage of development of therapies for Alzheimer’s disease. Longer duration of follow-up before observing any efficacy and resultant higher likelihood of missing data, and large intra- and inter-individual heterogeneity in symptomatic expressions pose significant challenges for interim decision-making in particular. In this workshop, we discuss some of the mistakes in futility analyses in AD trials, including those targeting pre-symptomatic participants, and provide practical considerations on how to improve the interim decision making process. After two lectures, a panel of statisticians and clinicians from industry, regulatory and academia will provide their perspectives on future directions for interim analyses.
Scott Emerson, Jian Zhu, Paul Aisen, Shobha Dhadda, Maria Tome, Dominic Trépel and Hiroko Dodge