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Session 6 – Subgroup Analyses
Session Chair(s)
Mark Rothmann, PhD
Division Director
FDA, United States
Joachim Vollmar, MSc
Executive Consultant
International Clinical Development Consultants LLC (ICDC), United States
Subgroup analyses are commonly conducted in completed confirmatory clinical trials with the objective of learning about differential treatment effects across subgroups. This is import for a comprehensive assessment of trials in marketing authorization applications, however, clinical trials are seldom properly planned for establishing an efficacy or safety claim for a subgroup in case the trial fails to establish the same claim for the total population. EMA (CHMP) has drafted a guideline on this topic. Presentations in this session will focus on methodological issues related to interpretation of subgroup findings from completed clinical trials and designing clinical trials with the objective of establishing efficacy/safety claims for the total population or a targeted subgroup and will be followed by a panel discussion with additional experts.
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
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