The methodology of clinical trials is continuously evolving, and there has been recent interest in platform clinical trials. Platform trials are a type of randomized clinical trial that allow simultaneous comparison of multiple intervention groups against a single control group that serves as a common control based on a prespecified interim analysis plan. Platform trials are an extension of adaptive multiarm, multistage trial designs that allow for the evaluation of multiple interventions using interim evaluations and the addition of new interventions during the trial.

Considering the frequent use of this study design, the EMA has published a concept paper on platform trials, which have become more common in recent years, for public consultation. They are frequently seen in Scientific Advice and more rarely as part of Marketing Authorisation Applications. This is likely to change in 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 of the planning, conducting, 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, rather than to replace or revise, existing guidance documents on multiplicity and adaptive design.

Comments regarding the concept paper should be provided using a dedicated template and sent to MWP@ema.europa.eu by 31 January 2023. The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations.

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