Trial Design

Multiple-Comparison Modeling Improves Dose Selection: EMA

Use of the “multiple comparison procedure – modeling,” or MCP-Mod, approach to dose response testing and estimation provides a “more solid basis” for Phase III dose selection, the European Medicines Agency says in a recently posted draft opinion on the methodology. Read More

Skin Infection Drug Requirements Eased in Final FDA Guidance

While the FDA generally requires two Phase III trials to support approval of drugs to treat acute bacterial skin and skin structure infections (ABSSSI), an Oct. 16 final guidance says a single Phase III study that is supported by additional independent evidence may suffice. Read More