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 (MAAs) 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 studies1 in electronic structured format that is directly accessible for analysis and visualisation. Examples of raw data include records of original observations and measurements of clinical study participants, such as clinical laboratory results, imaging data, and patient medical charts. Currently, the European medicines regulatory system does not routinely require the submission of raw data in the context of a marketing authorisation or post-authorisation application…
