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29 Sun, 8/8/2021, 1:30 PM - 3:20 PM Virtual
Statistical Issues Specific to Therapeutic Areas, Power and Sample Size Calculations, and Trial Monitoring — Contributed Speed
Biopharmaceutical Section
Chair(s): Jonathan Moscovici, QuintilesIMS
1:35 PM A Bayesian Network Meta-Analysis on Treatments of Brain Metastases in Patients with Non-Small Cell Lung Cancer
Uma Siangphoe, Johnson and Johnson
1:40 PM On Characterizing Survival Curve of CAR-T Cell Therapy
xiaoling wu, Legend Biotech
1:45 PM On Treatment Effect in Sequential Parallel Comparison Design
Xiaoyan Liu, Boston University; Zifei Han, University of International Business and Economics; Chanmin Kim, Sungkyunkwan University; Gheorghe Doros, Boston University
1:50 PM WITHDRAWN: Comparison of Methods for Adjusting for Crossover in Oncology Trials
Jin Zhang, Merck
1:55 PM Handling Multiple Imputation in Wilcoxon Signed-Rank Test: A Case Study Applied to a Hemophilia Clinical Trial
Eunhee Hwang, Pfizer Inc; Joseph Cappelleri, Pfizer Inc; Satrajit Roychoudhury, Pfizer Inc.; Dan Meyer, Pfizer
2:00 PM An Alternate Method to Find the Confidence Interval for the Difference Between Two Proportions of Rare Event
Ruji Yao, Merck & Co., Inc.; Amarjot Kaur, Merck & Co., Inc.; qing li, Merck & co., Inc.
2:05 PM A Flexible Ensemble Learning Method for Survival Extrapolation
Meijing Wu, Abbvie Inc.; Ran Dai, University of Nebraska Medical Center ; Yabing Mai, Boehringer Ingelheim; Weili He, AbbVie
2:10 PM Methods for Vaccine Efficacy in a Fixed Duration Design with Censoring
Ying Zhang, Merck & Co., Inc.; G. Frank Liu, Merck Sharp & Dohme Corp.; Radha A Railkar, Biostatistics and Research Decision Sciences, Merck & Co., Inc.
2:15 PM Novel Measures of Treatment Efficacy Under Delayed Treatment Effects
Kijoeng Nam, Merck & Co., inc. ; Nicholas Henderson, University of Michigan; Dai Feng, AbbVie Inc.
2:20 PM Sample Size Reestimation for the Finkelstein and Schoenfeld Test Statistic for a Composite Endpoint with Two Components
Thomas Zhou, Boston University; Joseph Massaro, Boston University
2:30 PM Power Analyses of Oncology Clinical Trials with Stratified Randomization
Xiao Fang, Merck; Paul DeLucca, Merck; Fang Liu, Merck & Co., Inc.; Xuan Deng, Merck & Co. Inc; Devan V Mehrotra, Merck & Co., Inc.
2:35 PM Something Out of Nothing? The Influence of 0-0 Studies in Bayesian Meta-Analysis of Drug Safety Studies
Zhaohu(Jonathan) Fan, University of Cincinnati ; Dungang Liu, University of Cincinnati; Yuejie Chen , North Carolina State University; Nanhua Zhang, Cincinnati Children's Hospital Medical Center
2:40 PM Incorporating Historical Controls in Analyses of Clinical Trial Data: An Empirical Power Prior Approach
Duncan Rotich, Bristol Myers Squibb; Yun Shen, Bristol Myers Squibb; Kay Tatsuoka, Bristol Myers Squibb
2:45 PM Do unadjusted pilot analyses lead to biased decision in proceeding to a larger trial?
Robert Montgomery, University of Kansas Medical Center
2:50 PM Optimizing Precision and Power in COVID-19 Trials by Covariate Adjustment
Nicholas Williams, Weill Cornell Medicine; Ivan Diaz, Weill Cornell Medical College; Michael Rosenblum, Johns Hopkins University
2:55 PM Collaborative Biostatistics as a Bridge from Preclinical Discovery to Population Data Science
Emily Slade, University of Kentucky; Heather Bush, University of Kentucky
3:00 PM Interim Analysis Incorporating Intermediate Binary Responses
Gang (Gerry) Li, Alexion Pharmaceuticals; Jiuzhou Wang, University of Minnesota Twin Cities; Jingnan (Jenna) Zhang, Alexion Pharmaceuticals
3:05 PM Predicting Analysis Times in Clinical Trials with Nonproportional Hazards
David Paulucci, Bristol Myers Squibb; Nikolas Weissmueller, Bristol Myers Squibb; Ming Zhou, Bristol Myers Squibb; Kay Tatsuoka, Bristol Myers Squibb
3:10 PM Realistic Patient-Level Simulators Considering Two Dependent Time-to-Event Endpoints
Yalin Zhu, Merck & Co Inc; Jing Zhao, Merck & Co., Inc.; Jing Wei, University of Kentucky
3:15 PM Floor Discussion