<2> Adherence to Legislation and Recommendations to Publicly Post Protocols and Results of Post-Authorisation Studies Registered with European Medicines Agency: Cross Sectional Study
<3> Background
The European Medicines Agency (EMA) requires EU risk management plan (RMP) category 1 and 2 studies to upload the protocol and results to the catalogue. The EMA also recommends uploading the protocol and results for all other registered post-authorisation studies, including EU RMP category 3 studies, non-EU RMP-only studies, and those not included in an RMP.
<4> Objective
To assess whether post-authorisation studies registered with the EMA adhere to legislation and recommendations to publicly post study protocols and results.
<5> Methods
Data extracted from the EMA Catalogue of real-world data studies in February 2024, including post-authorisation studies registered since November 2010.
<6> Results
Overall, protocols were available for 1370 (59.6%) of 2300 ongoing and finalised post-authorisation studies and results were available for 1014 (68.4%) of 1482 finalised post-authorisation studies.
<7> Discussion
Adherence to legislation and recommendations to publicly post protocols and