Halfway point of clinical trials ‘raw data’ pilot – applicants can still register to participate
date: 27/09/2023
The pilot collects practical learnings on operational, resource and technological aspects from all stakeholders involved in the pilot including CHMP. Initial insights will be gathered into an interim pilot report, a summary of which is expected to be published in early 2024.
Applicants or marketing authorisation holders (MAHs) that are planning to submit an initial or post-authorisation marketing authorisation application to EMA by the end of Quarter 1 of 2024 are still welcome to express their interest to participate in the pilot by writing to rawdatapilot@ema.europa.eu.
To date, industry stakeholders have been engaged contributing to the pilot's learnings and thus supporting discussions regarding future use of clinical trials ‘raw data’ in regulatory decision making. The Industry Focus Group on Raw Data, established in August 2022, provides a forum for industry stakeholders to share their views on specific design elements of the pilot. The Forum has been consulted on the learnings gathering approach that is being followed during the pilot.
It is noteworthy that the pilot team handles transparency and data protection aspects in accordance with relevant EU Regulation. Further information on transparency and data protection related matters, as well as on participating in the pilot can be found in the documents linked below and available on EMA’s Big Data webpage.
Application of EMA’s transparency principles to the raw data proof-of-concept pilot (europa.eu)
Records of data processing public - Raw Data Pilot (europa.eu)