CHMP Guideline on Subgroups finalised

4th Jun 2019

The CHMP Guideline on the investigation of subgroups in confirmatory clinical trials was published in draft form in September 2013. It has taken quite some time but we now have a final version - adopted 31st Jan 2019 and coming into effect on 1st August 2019.

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-subgroups-confirmatory-clinical-trials_en.pdf

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