Input to EMA guideline

On behalf of the IDeAl consortium, Stephen Senn issued a comment on the MCP-Mod as an efficient statistical methodology for model-based design and analysis of phase II dose finding studies under model uncertainty. He states that “We welcome this statement. Dose finding is one of the most difficult steps in drug development and the note provides a realistic assessment of the value of one flexible and useful approach to dose finding (the MCP Mod approach). It would be helpful to future potential users of this approach if the agency could state whether it would be prepared to consider the use of doses in subsequent stages of development that were identified by this method although not actually studied in Phase II. For example if the method suggested that the optimal dose would be one between two of the doses actually studied.”

Read full comment: Comments-on-MCP-MOD-guidance-by-IDEAL.