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