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Session Chair(s)
Mark Rothmann, PHD
Division Director, OTS, OB, CDER
FDA, United States
Joachim Vollmar, MSC
Executive Consultant
International Clinical Development Consultants LLC (ICDC), United States
Speaker(s)
Assessment of subgroups in significant and non-significant clinical trials
Armin Koch, DRSC
Hannover Medical School, Germany
Head, Institute of Biometry
Subgroup Analysis Issues in FDA-Reviewed Clinical Trials
Kathleen Fritsch, PHD
FDA, United States
Mathematical Statistician, Div. of Biometrics III, Off Biostatistics, OTS, CDER
Case Studies of Confirmatory Subgroup Analyses
Frank Bretz, PHD
Novartis , Switzerland
Distinguished Quantitative Research Scientist
Panelists
Mohamed A. Alosh, PHD
FDA, United States
Mathmatical Statistician
Mohammad Huque, PHD
FDA, United States
Office of Biostatistics, OTS, CDER, FDA
Ralph B. D'Agostino, PHD, MA
Boston University, United States
Chair, Mathematics and Statistics Department