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441 Thu, 8/12/2021, 4:00 PM - 5:50 PM Virtual
Bayesian (and Other) Clinical Trials Designs — Contributed Speed
Biopharmaceutical Section
Chair(s): Madan G Kundu, Daiichi Sankyo, Inc.
4:05 PM Statistical Properties of Phase 3 Randomized 3-Arm Umbrella Trials
Yixin Ren, Merck & Co., Inc.; Xiaoyun (Nicole) Li, Merck & Co.; Cong Chen, Merck & Co., Inc.
4:10 PM Operational Characteristics of Generalized Pairwise Comparisons for Hierarchically Ordered Endpoints
Vaiva Deltuvaite-Thomas, IDDI; Tomasz Burzykowski, IDDI
4:15 PM R Package Development for Evaluating Misclassification Effects on Single Sequential Treatment and Dynamic Treatment Regimens in Sequential Multiple Assignment Randomized Trial
Jun He, The Mayo Clinic; Jason Sinnwell, The Mayo Clinic; Abraham D. Eyman Casey, The Mayo Clinic; Donna K McClish, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University
4:20 PM WITHDRAWN: Data-Driven Design of Targeted Gene Panels for Estimating Immunotherapy Biomarkers
Jacob Richard Bradley, University of Edinburgh; Timothy Cannings, University of Edinburgh
4:25 PM A Review of Dynamic Bayesian Borrowing of Individual Patient Data (IPD) in Survival Analysis
Mohamad Hasan, Johnson & Johnson
4:30 PM Bayesian Design of Superiority Trials: Methods and Applications
Wenlin Yuan, University of Connecticut; Ming-Hui Chen, UCONN; John Zhong, REGENXBIO Inc.
4:35 PM Bayesian Logistic Regression with Covariates in Oncology Dose Escalation
4:40 PM Bayesian Multi-Regional Clinical Trials Using Model Averaging
Nathan Bean, University of North Carolina at Chapel Hill; Joseph G Ibrahim, UNC; Matthew Psioda, UNC Chapel Hill
4:45 PM WITHDRAWN: Dynamic Borrowing Design for Randomized Study with Time-to-Event Endpoint
Zangdong He, GlaxoSmithKline; Wei Guo, GlaxoSmithKline (former employee); Ilker Yalcin, Adagio Therapeutics
4:50 PM Could Simulation Enrich Power Analysis and Sample Size Justification? A Case of Survival Analysis for Illustration
Dung-Tsa Chen, Moffitt Cancer Center
5:00 PM Dampening Placebo Effect with Enriched Run-In Design in Randomized Clinical Trials
Ping Xu, Merck & Co.; qing li, Merck & co., Inc.; Richard Entsuah, Merck & Co.
5:05 PM Replicate Testing Strategies in Vaccine Efficacy Trials Can Prevent No-Go Decisions for Beneficial Vaccines
Radha A Railkar, Biostatistics and Research Decision Sciences, Merck & Co., Inc.; Jeffrey Sachs, Merck & Co.; Daniel Rosenbloom, Merck & Co.
5:10 PM Facilitating go/no-go decision in early phase study with Average Distance to Decision threshold (ADD)
Danni Yu, Nektar Therapeutics
5:15 PM An Updated Pick-the-Winner Design Allowing a Flexible Allocation Ratio at Stage Two
Bing Liu, University of Kansas, Medical Center; Jianghua He, University of Kansas Medical Center
5:20 PM Pediatric Trial with Partial Extrapolation
Madhuja Mallick, Abbvie
5:25 PM Multi-Arm, Multi-Stage Clinical Trials for Time-to-Event Outcomes
Vaidehi Ulhas Dixit, North Carolina State University; Priyam Mitra, Bristol Myers Squibb; Katy Simonsen, Bristol Myers Squibb
5:30 PM Have the Stories Changed? Clinical Trial Data Analysis During a Pandemic
Nicole C Close, EmpiriStat, Inc.
5:35 PM Adjustment of Alpha for Final Analysis per Actual Number of Events in Event-Driven Clinical Trials Using Group Sequential Testing Procedure
Li Wei, Bristol Myers Squibb; Stephen Lane, Bristol Myers Squibb
5:40 PM Treatment Response vs. Treatment Effect
Lev S Sverdlov, Redmond Analytics LLC