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SUBGROUP ANALYSES
Session Chair(s)
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 effect 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. The CHMP is currently preparing 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.
Speaker(s)
Assessment of Subgroups in Significant and Non-Significant Clinical Trials
Armin Koch, DrSc
Hannover Medical School, Germany
Head, Institute of Biometry
Confirmatory Subgroup Analyses: Case studies
Frank Bretz, PhD
Novartis , Switzerland
Distinguished Quantitative Research Scientist
Subgroup Selection: Adaptive Clinical trials
Vladimir Dragalin, PhD
Janssen R&D, at Johnson & Johnson, United States
Vice President, Scientific Fellow
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