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Activity Number: 75 - Clinical Trial Design-1
Type: Contributed
Date/Time: Sunday, July 29, 2018 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract #330685 Presentation
Title: MCP-Mod Based Quantitative Techniques for Decision Making Process in Phase II Dose-Finding Clinical Trials
Author(s): Na Cai* and Annie Wang and Michael Smith
Companies: Astellas and Astellas Pharma and Astellas
Keywords: Bootstrap; Clinical Trials; Dose-Finding; MCP-Mod; Quantitative Decision Making

Informed decisions on moving a drug to phase III based on phase II data mitigates late-stage failure risk. Many quantitative techniques beyond p-values incorporating additional metrics have been developed for decision making. We extend the decision making process to Multiple Comparison Procedure and Modeling (MCP-Mod) based phase II dose finding studies. MCP-Mod is an efficient statistical method for model-based design and analysis of phase II dose-finding studies, which has been endorsed by regulatory agencies. The modeling approach in MCP-Mod allows us to integrate all available data and interpolate information across dose levels and hence provides more information and a solid basis for decision making. We will discuss the practical issues in MCP-Mod based decision making and propose various quantitative techniques based on bootstrap model averaging method. Simulation studies were performed to evaluate the performance and robustness of the proposed techniques under different scenarios.

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

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