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Activity Number: 673 - Clinical Trial Design- 8
Type: Contributed
Date/Time: Thursday, August 2, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #327196 Presentation
Title: A Simulation Study Comparing MCP-Mod and a Model-Based Approach in Phase 2a Clinical Trials
Author(s): Hongtao Zhang* and Alan Hartford
Companies: and AbbVie Inc
Keywords: Phase 2a; MCP-Mod; Proof of activity; Dose-response modeling

In general, the statistical methods to establish proof of activity (PoA) in phase 2a clinical trials can be categorized by the use of one of three approaches: non-model-based, model-based , and the hybrid MCP-Mod. Over the past decade, MCP-Mod has gained much popularity among industry statisticians over the classical non-model-based approaches. In this research, we focus on the comparison between the MCP-Mod and a model-based approach. Through simulation studies, we compare the operating characteristics of the two methods, in particular, the ability to control the type I error rate.

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

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