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.