Online Program Home
  My Program

All Times EDT

Abstract Details

Activity Number: 409 - Complex Innovative Approaches in Emerging Neurodegenerative / Neuroimaging Drug Developments
Type: Topic Contributed
Date/Time: Wednesday, August 5, 2020 : 1:00 PM to 2:50 PM
Sponsor: Biopharmaceutical Section
Abstract #313524
Title: Statistical Issues and Challenges Seen in Drug Development for Neurodegenerative Diseases
Author(s): Tristan Massie*
Companies: FDA
Keywords: estimand; intercurrent events

A senior FDA statistical reviewer's perspective on some of the common statistical challenges arising in Neurology clinical trials. Common major issues are how to handle potentially biasing intercurrent events such as death or starting of other active treatments, the impact of missing data in general, and special considerations for interim analyses with a continuous longitudinal outcome measure. Examples and simulation results will be provided to illustrate the shortcomings of some methods seen in practice and potential alternatives.

Authors who are presenting talks have a * after their name.

Back to the full JSM 2020 program