Value of Real World Evidence (RWE) in regulatory decision making process
To fulfill the EU vision to enable the use of RWE and establish its value across regulatory use cases by 2025, last week EMA published a Reporton the experience gained with regulator-led studies from September 2021 to February 2023.
The report focuses on the use of real-world data (RWD) in regulatory decision-making. There were a total of 61 research topics identified, including those related to the COVID-19 pandemic and pharmacovigilance strategies. Most studies were conducted in-house, with some through the DARWIN EU® platform, which we have mentioned before in the publication 'Impact of Big Data on medicine regulatory network'. Feasibility challenges were observed in certain therapeutic areas and rare diseases. Efforts to expand RWD pilots and enhance collaboration with stakeholders are ongoing. The report emphasizes the need for wider access to diverse data sources and faster RWD generation. Educational tools and better anticipation of research questions are recommended for improvement.
The report was discussed during the EMA Multi-stakeholder workshop on RWD quality and RWE use on 26-27 June.
These next steps were identified:
- Implement recommendations of the report;
- Learnings and recommendations will feed into the work of Big Data Steering Group (BDSG) and the establishments of DARWIN EU®;
- Pilot activities will continue until sufficient experience is obtained.
Review of RWE use in regulatory decision-making process will be continued in coming years.
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