Contributed Papers

Early Phase Trials: Pioneering Innovative Design Approaches

Wed, Aug 6, 10:30 AM - 12:20 PM Room CC-207D Music City Center

Biopharmaceutical Section

7 Presentations

Assessment of Unequal Randomization in Clinical Trial Design

10:35 AM - 10:50 AM

Co-authors: Luoying Yang (Bristol-Myers Squibb), Weijia Mai (Duke University School of Medicine Dept. of Biostatistics & Bioinformation), Luoying Yang (Bristol-Myers Squibb), Yuanyuan Han (Bristol Myers Squibb)

Randomization Probability of success Optimization Trial Design Oncology Survival Analysis

Comparing Statistical Models for Analysis of Early Fungicidal Activity Data

10:50 AM - 11:05 AM

Co-authors: Monica Fuszard (Merck & Co., Inc.), Biyue Dai (University of Minnesota), Monica Fuszard (Merck & Co., Inc.), David Boulware (University of Minnesota)

HIV cryptococcal meningitis early fungicidal activity clinical trial longitudinal data infectious disease

Designing Sequential Multiple-Assignment Randomized Trials (SMARTs) for Learning Treatment Rules

11:05 AM - 11:20 AM

Co-authors: John Sperger, John Sperger, Michael Kosorok (University of North Carolina at Chapel Hill)

Experimental Design Precision Medicine Dynamic Treatment Regimes Off-policy Estimation Causal Inference Decision-making

Interim Analysis in Sequential Multiple Assignment Randomized Trials for Survival Outcomes

11:20 AM - 11:35 AM

Co-authors: Zi Wang (University of Pittsburgh), Yu Cheng (University of Pittsburgh), Zi Wang (University of Pittsburgh), Abdus Wahed (University of Rochester)

Log-rank Statistics Dynamic Treatment Regimes Interim Monitoring Efficacy Boundaries Inverse Probability Weighting Trial Efficiency

Pareto-Optimal Designs for Two-Stage Phase II Trials

11:35 AM - 11:50 AM

Co-authors: Seongho Kim (Wayne State University), Seongho Kim (Wayne State University)

Phase II Simon's two-stage design Pareto frontier Multi-objective optimization

Risk-inclusive Contextual Bandits for Early Phase Clinical Trials

11:50 AM - 12:05 PM

Co-authors: Rohit Kanrar, Chunlin Li (Iowa State University), Rohit Kanrar, Margaret Gamalo (Pfizer), Zara Ghodsi (Pfizer)

Anytime-valid policy evaluation Dose-ranging studies Efficacy and Safety Model-assisted inference Sequential causal inference

STEIN-NETS: A Simple Toxicity and Efficacy Interval Design with Normalized Equivalent Toxicity Score

12:05 PM - 12:20 PM

Co-authors: Jieqi Tu, Jieqi Tu, Zhengjia Chen (University of Illinois Chicago), Hao Sun (Bristol Myers Squibb)

Normalized Equivalent Toxicity Score Bayesian Adaptive Design Dose Finding Phase I/II Clinical Trials