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European Medicines Agency public consultation – concept paper

The European Medicines Agency has published for public consultation a concept paper on platform trials. 

Platform trials have become more common in recent years. Currently, they are frequently seen in Scientific Advice and more rarely as part of Marketing Authorisation Applications. This is, however, likely to change during the coming years. They contain some unique, mostly methodological, aspects and it has become apparent that a reflection paper is needed to enable adequate planning of platform trials such that they can be used as pivotal trials. 

Platform trials increase the complexity in planning, conduct and reporting of a clinical trial. A consolidated position to address these challenges is needed and will be outlined in the reflection paper. 

The aim of the reflection paper is to complement existing guidance documents, e.g. on multiplicity and adaptive design, and not to replace or revise them. 

Comments should be sent to [email protected] by 31 January 2023.