EMA Consults On Need For New Guide To Enable Confirmatory Platform Trials

22 Nov 2022

The European Medicines Agency believes that a scientific guideline on clinical trials incorporating a platform design is needed because such studies are expected to play an increasingly important role in future marketing authorization applications.

Young businessman thinks over the steps for successful growth: Clinical trial — Platform Trials Allow Multiple Treatments To Be Evaluated Simultaneously • Source: Shutterstock

The European Medicines Agency is inviting stakeholder feedback on its plan to draw up a reflection paper to address the unique methodological challenges posed by platform trials in terms of planning and conducting such studies and reporting the results.

Platform trial is a broad term used for trial designs characterized by a shared framework that allows for the evaluation...