Adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with European Medicines Agency: cross sectional study.

Abstract

To assess whether post-authorisation studies registered with the European Medicines Agency (EMA) adhere to legislation and recommendations to publicly post study protocols and results. Cross sectional study. Data extracted from the EMA Catalogue of real-world data studies in February 2024, including post-authorisation studies registered since November 2010. EU legislation 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. 2300 (1484 finalised; 816 ongoing) post-authorisation studies for protocol availability and 1482 finalised post-authorisation studies (excluding two recently finalised post-authorisation studies) for results availability. Public availability of protocols for ongoing and finalised post-authorisation studies and results (abstract and/or final report) for finalised post-authorisation studies. 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. For ongoing and finalised post-authorisation studies according to RMP requirements, protocols were available for 76 (68%) of 112 EU RMP category 1 studies, 21 (64%) of 33 EU RMP category 2 studies, 419 (67.0%) of 625 EU RMP category 3 studies, 87 (67%) of 129 non-EU RMP-only studies, and 715 (55.3%) of 1292 post-authorisation studies not included in an RMP. For finalised post-authorisation studies, results were available for 61 (90%) of 68 EU RMP category 1 studies, 17 (90%) of 19 EU RMP category 2 studies, 304 (75.8%) of 401 EU RMP category 3 studies, 56 (69%) of 81 non-EU RMP-only studies, and 547 (64.1%) of 853 post-authorisation studies not included in an RMP. Adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with the EMA is insufficient: only 6 of every 10 finalised and ongoing post-authorisation studies had uploaded a protocol and less than 7 of every 10 finalised post-authorisation studies had uploaded results to the EMA Catalogue of real-world data studies. Adherence was particularly poor among post-authorisation studies not included in an RMP subject to recommendations (but no legal obligation) to post the protocol and results. Assessing data on the upload status of the protocols and results of EMA registered post-authorisation studies is feasible and helps to scrutinise whether post-authorisation studies adhere to legislation and recommendations. Better adherence is needed for greater research transparency.