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Activity Number: 658
Type: Contributed
Date/Time: Thursday, August 13, 2015 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #317232
Title: Sample Size Considerations for Dose-Finding with MCP-Mod
Author(s): Sergei Leonov* and Tobias Mielke
Companies: ICON Clinical Research and ICON PLC
Keywords: MCP-Mod ; Dose finding ; Adaptive design ; Sample size and power ; Target dose ; Precision of estimation
Abstract:

Determination of appropriate dose levels for Phase 3 confirmatory testing is one of the major goals of Phase 2 clinical drug development. The MCP-Mod approach, as a combination of a model-based trend test with model-selection and dose-estimation steps, was qualified in 2014 by European Medicines Agency (EMA) as an efficient methodology for the design and analysis of dose-finding studies under model uncertainty. A simple calculation of the sample size to target the power of the model-based trend test may not be sufficient for determination of the target dose. In this presentation we will discuss different approaches for sample size determination for studies using MCP-Mod, including methods based on precision of estimation of the target dose and sample size re-assessment, and compare their benefits and limitations via a case study.


Authors who are presenting talks have a * after their name.

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