The European Medicines Agency (EMA) has announced the opening of public consultation on the Draft Reflection paper regarding the use of real-world data in non-interventional studies to generate real-world evidence. This paper discusses methodological and data quality aspects of such studies for regulatory purposes.
Interested parties involved in planning, conducting, and analysing non-interventional studies using real-world data are invited to provide feedback on the draft reflection paper by August 31, 2024. Additionally, a dedicated session will be held during the multi-stakeholder joint HMA-EMA workshop on RWE methods on June 14, 2024, to present and discuss the reflection paper and gather initial feedback.
The development of this reflection paper aligns with the Methodology Working Party Workplan 2022-2024 and the joint HMA-EMA Big Data Steering Group plan 2023-2025, focusing on goals related to the development of real-world evidence guidance.
You can read the draft guideline here.
References
- Committee for Human Medicine Products (CHMP). (2024). Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. In European Medicines Agency (EMA/CHMP/150527/2024; pp. 2–16). https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-real-world-data-non-interventional-studies-generate-real-world-evidence_en.pdf
Disclaimers
- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
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