Abstract:
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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.
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