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Key Multiplicity Issues in Clinical Trials
Session Chair(s)
Alex Dmitrienko, PhD
Executive Director, Center for Statistics in Drug Development
Quintiles Inc., United States
This session will discuss key multiplicity issues arising in confirmatory clinical trials, including commonly used statistical methods, regulatory considerations presented in the draft FDA multiplicity guidance and case studies.
Learning Objective : Identify common multiplicity problems in clinical trials; Define statistical methods used for addressing multiplicity; Identify the factors that influence the selection of methods used in multiplicity problems; Discuss key regulatory requirements in this area.
Speaker(s)
Multiple Endpoints in Clinical Trials: A Regulatory Perspective
Mohammad Huque, PhD
FDA, United States
Office of Biostatistics, OTS, CDER, FDA
Key Multiplicity Issues in Clinical Drug Development
Ralph B. D'Agostino, PhD, MA
Boston University, United States
Chair, Mathematics and Statistics Department
Analysis of Clinical Trials with Multiple Objectives
Alex Dmitrienko, PhD
Quintiles Inc., United States
Executive Director, Center for Statistics in Drug Development
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