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CC = Walter E. Washington Convention Center   M = Marriott Marquis Washington, DC
* = applied session       ! = JSM meeting theme

Activity Details

555 Thu, 8/11/2022, 10:30 AM - 12:20 PM CC-156
Novel Methods in Estimation Enhancement — Contributed Papers
Biopharmaceutical Section
Chair(s): Qing Yin, FDA
10:35 AM A Closer Look at Stratification/Stratified Analyses in Randomized Clinical Trials
Devan V. Mehrotra, Merck & Co., Inc.; Rachel Marceau West, Merck & Co., Inc.
10:50 AM Validity of Tests for Time-to-Event Endpoints in Studies with Minimization
Victoria P Johnson, GSK; Michael Gekhtman, University of Notre Dame; Olga Kuznetsova, Merck
11:05 AM Inferential Ambiguity Is Created by Health Measures with Questionable Validation Even in the Context of Randomized Clinical Trials That Demonstrate a Treatment Effect
Lili Garrard, U.S. Food and Drug Administration; Kevin Weinfurt, Duke University; Laura Lee Johnson, U.S. Food and Drug Administration
11:20 AM Exploring Heterogeneity in Nonlinear Trajectories with Linear Spline Functional Form in the Framework of Individual Measurement Occasions
Jin Liu, Vertex Pharmaceuticals; Tu Xu, Vertex Pharmaceuticals; Yijie Zhou, Vertex Pharmaceuticals; Tianchen Xu, Columbia University
11:35 AM Robustly Leveraging the Post-Randomization Information to Improve Precision in the Analyses of Randomized Clinical Trials
Yu Du, Eli Lilly and Company; Bingkai Wang, University of Pennsylvania
11:50 AM Using Targeted Maximum Likelihood Estimation to Estimate Treatment Effect with Longitudinal Continuous or Binary Data: A Systematic Evaluation of 28 Clinical Trials
Lingjing Jiang, Johnson & Johnson
12:05 PM Floor Discussion