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518 Thu, 8/11/2022, 8:30 AM - 10:20 AM CC-204C
Estimand, Causal Inference, and Other Statistical Considerations in Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Victoria P Johnson, GSK
8:35 AM When Estimating Causal Effects, Start by Defining Causal Estimands—Not Estimators
Marie-Abele Bind, Massachusetts General Hospital; Eric Macklin, Massachusetts General Hospital; Donald Rubin, Tsinghua University
8:50 AM The Inherent Meaningfulness of a Novel Time Component Test (TCT): Combining Evidence Across Outcomes to Measure the Impact of Treatment on Progression Rate in Degenerative Diseases
Nathaniel Hogan, Pentara; Jessie Johnson, Pentara; Newman Knowlton, Pentara; Sean Hennessey, Pentara Corporation; Suzanne Hendrix, Pentara; Samuel Dickson, Pentara
9:05 AM Selection of Analysis Method for GOS-E in Future TBI Clinical Trials Using Retrospective Data
Yu Wang, University of Kansas Medical Center; Byron Gajewski, University of Kansas Medical Center
9:20 AM Use of Benefit-Risk, Safety, and Estimand Planning Tools to Optimize Drug Approvability and Labeling
Susan Mayo, Food and Drug Administration, Center for Drug Evaluation
9:35 AM A Bayesian Framework for Identifying Safety-Signal from Multiple Studies
Adrijo Chakraborty, U.S.Food and Drug Administration; Ram Tiwari, Bristol Myers Squibb
9:50 AM Bayesian Approach to Principal Stratum in a Clinical Setting
Dominique McDaniel, Drexel University ; Ahmad Hakeem Abdul Wahab, Janssen Pharmaceuticals; Run Zhuang, Purdue University; Arman Sabbaghi, Purdue University
10:05 AM Connecting P-Values and Posterior Probabilities Through Bayes Factor Bound: A Brief History and Its Application
Xiting Yang, FDA; Greg Maislin, Biomedical Statistical Consulting; Dongfeng Qi, Boston Scientific