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

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.