Reducing Late-Phase Trial Costs, Failures

Multiple Comparison Procedure – Modelling (MCP-Mod) is a powerful statistical tool that greatly improves the design and analysis of dose finding studies for more accuracy on the targeted dose range. It is deemed “fit-for-purpose” by the FDA after an exhaustive qualification analysis in 2015. MCP-Mod is an “efficient statistical methodology for the model-based design and analysis of dose-finding studies under model uncertainty.

Combined with the adaptive study design, simulation and modelling capabilities of ICON’s ADDPLAN® neo, adaptive MCP-Mod may significantly enhance drug development efficiency. Adaptive MCP-Mod designs help to reduce costs in futile developments programs, while preserving predictive insight in successful development programs, actively supporting early development preparations leading to shortened timelines.