Platform trials - Scientific guideline

Platform trials 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. 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.

Keywords: Platform trials, trial design, master protocols, multiplicity

Current version

Concept paper on platform trials

Draft: consultation closed Consultation dates: 11/11/2022 to 31/01/2023 Reference Number: EMA/CHMP/840036/2022 Summary:

Platform trials 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. 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.