Posted by Michael Wonder on 12 Jul 2022
EMA launches pilot project on analysis of raw data from clinical trials
12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications for new medicines as well as post-authorisation applications and to explore the practical aspects of the submission and analysis of such data.
Raw data constitutes individual patient data from clinical studies in electronic structured format that is directly accessible for analysis and visualisation.
