Posted by Michael Wonder on 23 Apr 2023
EMA addresses considerations for single-arm trials
21 April 2023 - A new reflection paper from the EMA offers some suggestions to sponsors on how to design single-arm trials and strategies for minimising bias in these trials to support new marketing authorisation applications
The paper aims to “stimulate the scientific discussion around key concepts and challenges associated with single-arm trials and to improve their design and conduct,” announced EMA.
