Session 4: September 8-11, 2008
Confirming Trials: Methodology and Biostatistics
Session Co-Leaders: Christy Chuang-Stein, PhD, Pfizer; Robert O'Neill, PhD, Food and Drug Administration; and Stephen Senn, MSc, PhD, CStat, University of Glasgow
Session Chairs: Christy Chuang-Stein, PhD, Pfizer; Paul Gallo, PhD, Novartis; and Stephen Wilson, PhD, Food and Drug Administration
The different tests and methods of biostatistics are discussed. The application of different trial designs is simulated, within-trial decisions, data management, extraction, manipulation and storage of data.
Frontiers in Drug Development and Regulatory Science Series on September 11.
- Biostatistical Concepts and Principles for Confirmatory Clinical Trials
- Basic Statistical Concepts
- Choice of Endpoints
- Sample Size Planning
- Data Management, Data Standards (CDISC), Data Quality, and Their Impact on Decision Making
- Choosing a Study Design
- Statistical Analysis Plan
- Attrition in Randomized Controlled Clinical Trials
- Choice of Endpoints
- Exploratory vs. Confirmatory Trials
- Multiple Comparisons/Endpoints
- Multi-center and Multi-regional Trials
- Sequential Design and Analysis Meta Analysis: How to Get it Right?
- Adaptive Designs: An Overview
- Data Monitoring Committee (Data Safety Monitoring Board)
- Safety Analysis: Points to Consider
- Meta Analysis: How to Get It Right?
Teaching Faculty
Keaven Anderson, PhD, Merck
Christy Chuang-Stein, PhD, Pfizer
Ralph D'Agostino, Sr, PhD, Boston University
Scott Emerson, MD, PhD, University of Washington
Paul Gallo, PhD, Novartis
Frank E. Harrell, Jr, PhD, Vanderbilt University
Joseph Heyse, PhD, Merck
HM James Hung, PhD, Food and Drug Administration
Mohammad Huque, PhD, FASA, Food and Drug Administration
Byron Jones, PhD, Pfizer
Andrew C. Leon, PhD, Cornell University
Jeff Maca, PhD, Novartis
Ralph O'Brien, PhD, Case Western Reserve University
Robert O'Neill, PhD, Food and Drug Administration
George Rochester, PhD, Food and Drug Administration
Barry Schwab, PhD, Johnson & Johnson
Stephen Senn, Msc, PhD, CStat, University of Glasgow
Steve Snappin, PhD, Amgen
Roy Tamura, PhD, Eli Lilly
Lee-Jen Wei, PhD, Harvard University
Janet Wittes, PhD, Statistics Collaborative
Stephen Wilson, PhD, Food and Drug Administration
