The European Medicines Agency has published a report on the experience gained in conducting studies with real-world data.
Real-world evidence from studies led by regulators can complement evidence from other sources including clinical trials. Real-world evidence can support both pre-authorisation and post-approval assessments. However, more effort is needed to better anticipate the need for such studies and to speed up their initiation to ensure that regulators have access to real-world evidence in a timely manner.
The report covers the period from September 2021 until February 2023 (the first anniversary of the Data Analysis and Real-World Interrogation Network DARWIN EU®). During this period, 61 Real World Data research opportunities were identified, 30 studies initiated and 27 completed.
The report includes a set of recommendations to address identified opportunities and challenges with use of real-world evidence in regulatory decision making.
Further work is needed to enable the use of Real-world evidence and establish its value across regulatory use cases by 2025. To this end, the learnings and recommendations arising from the report will feed into the work of the Big Data Steering Group and further inform the establishment of DARWIN EU®.