EMA Open Consultation on "Concept paper on Platform Trials" just started

Last friday, EMA started the Open Consultation for the "Concept paper on platform trials".

The proposed timelines (page 3) are:

• Establishment of drafting group 12/2022,
• Discussion at CHMP 12/2023,
• Proposed date for release of?draft guideline 03/2024,
• Deadline for comments 06/2024,
• Re-discussion in MWP 09/2024.
• Expected?date for adoption by CHMP 12/2024.

2 key elements for me into it (both from Problem Statement):

• "Platform trials increase the complexity in planning, conduct and reporting of a clinical trial". This will have to be carefully evaluated, especially in relation with the Clinical Trials Information System (CTIS).
• "Firstly, the aim is to clarify terminology and introduce the key concepts". There is clearly a need here, to be sure terms & concepts are used & understood the same way.

https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-platform-trials_en.pdf