08:30 AM‑09:30 AM:Dr. Vernon M. Chinchilli, Department of Public Health Sciences
Penn State College of Medicine and
Dr. Michele L. Shaffer, Seattle Children's Core for Biomedical Statistics Seattle Children's Research Institute
N-of-1 Trials: Do They have a Role in Clinical Research?
09:30 AM‑10:30 AM:C V Damaraju, Pragmatic Trials -Shifting to a New Normal
11:00 AM-12:00 PM:Nitis Mukhopadhyay, Applications of Sequential Methodologies
1:00 PM-2:00 PM:Satrajit Roychoudury, The Non-Proportional Hazard Model
02:00 PM-05:00 PM:Craig Mallinckrodt and Bohdana Ratitch, Preparing for the New ICH E9 Guidance on Estimands and Sensitivity
08:30 AM-09:30 AM:JIng Zhao, Bayesian Approach for Neoadjuvant/Adjuvant Oncology Trials
09:30 AM-10:30 AM:Shankar Srinivasan, State Transition Graphics with Extensions to Tumor Response Data
10:45 AM-11:45 PM:Ramses Sadek, Considerations for Design and Analysis of Oncology Trials
01:00 PM-02:00 PM:Qing Lu, Evidential Paradigm for Statistical Inference by which Frequentist and Bayesian are Special Cases
02:00 PM-03:00 PM:Jiajun Liu/Eric Nantz, Overview of Multiplicity Adjustment Issues in Clinical Trials and Examples
03:30 PM-05:30 PM:Poster Session
08:30 AM-10:30 AM:Mark Rothmann, Non-inferiority Issues Discussed at Recent FDA Final Guidance
Aloka Chakravarty, Multi-regional Clinical Trials (MRCT) ICH E17 Document
11:00 AM‑12:00 PM:Yoko Tanaka,
Short Courses:
Wednesday-Thursday (1 Day)
SC‑1:Richard Simon: Bayesian Statistics Without the BS
Thursday-Friday (1 Day)
SC‑2:Charlie Liu: Producing High-quality Figures in SAS to Meet Publication Requirements - with Practical Examples