EMA – Publication of the Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application
Following a public consultation, the Methodology Working Party (MWP) has finalised the Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation.
The reflection paper discusses key issues and requirements for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the European Union (EU).
More information on the EMA Website.
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vroby (21 octobre 2024). EMA – Publication of the Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application. ELSIBI. Consulté le 19 janvier 2025 à l’adresse https://doi.org/10.58079/12jhq
