EMA – Presentation of Concept Paper on platform trials (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022)
The EMA is proposing a reflection paper to support the planning of platform trials, so 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.
A draft concept paper has been adopted by the Committee for Medicinal Products for Human Use (CHMP) for release for public consultation. Comments on this concept paper can be submitted until 31st January 2023.
See all of Catapult’s Regulatory Round-up for November 2022 here. Published on the 8th of December 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (25 janvier 2023). EMA – Presentation of Concept Paper on platform trials (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022). ELSIBI. Consulté le 5 mars 2026 à l’adresse https://doi.org/10.58079/o67l





