CTAM PIA: Perspectives on Adaptive Trials and Future Trial Designs

Recorded: August 11, 2021

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 provide their perspectives on future directions for interim analyses.

Panelists:
Scott Emerson, Jian Zhu, Paul Aisen, Shobha Dhadda, Lon Schneider, Maria Tome, Dominic Trépel, Hiroko Dodge