EMA has published a draft reflection paper on the use of real-world data (RWD) in non-interventional studies to generate real-world evidence (RWE), which discusses methodological and data quality aspects of such studies. The development of this paper is part of the Methodology Working Party Workplan 2022-2024 and the joint HMA-EMA Big Data Steering Group plan 2023-2025.
Interested partners and stakeholders involved in the planning, conduct and analysis of non-interventional studies are invited to provide feedback on the draft reflection paper until 31 August 2024.
The reflection paper will also be presented to gather initial feedback in a dedicated session at the multi-stakeholder joint HMA-EMA workshop on RWE methods on 14 June 2024.
Related information:
- Draft reflection paper
- Contact point: MWP
ema [dot] europa [dot] eu (MWP[at]ema[dot]europa[dot]eu)
Details
- Publication date
- 13 May 2024
- Author
- European Medicines Agency