Contributed Papers

Innovative Approaches to Clinical Trial Design and Analysis

Thu, Aug 7, 8:30 AM - 10:20 AM Room CC-211 Music City Center

Biopharmaceutical Section

6 Presentations

Evaluating Innovative Composite Scoring methods to Optimize Power and Sample Size in Clinical Trials

8:35 AM - 8:50 AM

Co-authors: Rachana Lele (Biostatistician II, Syneos Health), Shesh N. Rai (Biostats, Health Inform & Data Sci | College of Medicine), Rachana Lele (Biostatistician II, Syneos Health)

composite score power sample size clinical trials multiplicity

Exact power and sample size in clinical trials with two co-primary binary endpoints

8:50 AM - 9:05 AM

Co-authors: Gosuke Homma (Astellas Pharma Inc), Takuma Yoshida (Kagoshima University), Gosuke Homma (Astellas Pharma Inc)

binary endpoint co-primary endpoints correlation exact power sample size

Justifying the sample size for a factorial trial

9:05 AM - 9:20 AM

Co-authors: Phuc Vu, Alex Dahlen (New York University, School of Global Public Health), Phuc Vu, Jillian Strayhorn (New York University School of Global Public Health), Ruoxiang Zheng (New York University School of Global Public Health)

factorial trial power analysis

Weighted Upstrap Futility Monitoring: Algorithmically Accounting for Data Driven Time Trends

9:20 AM - 9:35 AM

Co-authors: Jess Wild, Jess Wild, Alexander Kaizer (University of Colorado Anschutz Medical Campus)

Clinical trials Interim futility monitoring Weighted upstrap Time trends Nonparametric Alpha-spending

Overview of statistical methods for binary endpoint in immunology clinical trials

9:35 AM - 9:50 AM

Co-authors: Pascal Minini (Sanofi), Xiaomei Liao (Sanofi), Ning Li (Sanofi), Xiaomei Liao (Sanofi)

Immunology clinical trial binary endpoints CMH analysis odds ratio rate difference

Sensitivity in Sample Size Determination in Cluster Randomized Trials for Count Data

9:50 AM - 10:05 AM

Co-authors: Taylor Lefler (University of Mississippi Medical Center), Philip Turk (Northeast Ohio Medical University), Taylor Lefler (University of Mississippi Medical Center), William Hillegass (University of Mississippi Medical Center), Karla Hemming (University of Birmingham), Dustin Long (Wake Forest School of Medicine), Marc Kowalkowski, Lei Zhang (University of Mississippi Medical Center)

count outcome cluster randomized trial parameter uncertainty sample size sampling variability