Statistics and Data Science Seminar
Li Wang
AbbVie Inc.
Enhanced Understanding of MCPMod in Dose-ranging Studies
Abstract: In dose ranging clinical trials, it is critical to investigate the dose-response profile and to identify a minimum effective dose (MED) to guide the dose selection for phase 3 confirmatory trials. Traditional dose ranging trials focus on pairwise comparisons between placebo and each investigational dose, while in recent years MCP-Mod (Multiple Comparison Procedures & Modeling) arose and gained popularity in the design and analysis of dose ranging trials. Comprehensive comparison between MCP-Mod and other methods have been made on continuous variables assuming a normal distribution. We extend the comparison to binary/binomial response variables. Via simulation, the rate of correct and incorrect MED identification are compared for Dunnett's test, trend test and MCP-Mod for a variety of underlying dose response profiles including both monotone and non-monotone dose responses and are compared under a large number of trial design settings. The precision of MED estimation using MCP-Mod is also evaluated comparing the design options of more dose levels and smaller sample size per dose versus fewer dose levels and larger sample size per dose
Wednesday February 28, 2018 at 4:00 PM in SEO 636