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Session 8 – Phase 2 Dose-Finding Studies, Part I
Session Chair(s)
Jose C. Pinheiro, PhD
Head of Statistical Modeling and Methodology, SDS
Janssen Research & Development, LLC, United States
H. M. James Hung, PhD
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
FDA, United States
This is an intertwined pair of sessions focused on statistical and modeling methods for dose finding studies. Dose selection remains one of the most challenging steps in clinical drug development, being directly associated with the success, or failure, of confirmatory studies and regulatory submissions. A common approach drug development has been to consider a dose finding study (also referred to as Phase 2B trial) as having the potential to be a pivotal study in the program. As a result, emphasis has been placed on multiple comparisons between active doses and control with strong control of Type I error, making studies that should, in principle, be exploratory in nature, look more like mini-Phase 3 studies. Poor dose selection has often been observed in such cases, eventually leading to costly failures in confirmatory programs or regulatory submissions. In the first session, three expert speakers (from regulatory agencies and industry) will review some of the critical issues related to dose finding studies and will present alternative, potentially more efficient dose selection approaches, including model-based methods.
Speaker(s)
MCP-Mod: A Statistical Approach to Design and Analyze Phase II Dose Finding Studies
Frank Bretz, PhD
Novartis , Switzerland
Distinguished Quantitative Research Scientist
Dose Response and Dose Finding
H. M. James Hung, PhD
FDA, United States
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
Dose Finding Dose - Exposure Response Characterisation
Efthymios Manolis, PharmD, MSc
European Medicines Agency, Netherlands
Scientific Administrator
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