Many post-authorization studies fail to comply with public disclosure rules

(Press-News.org) Many post-authorisation studies registered with the European Medicines Agency (EMA) fail to comply with legal requirements and recommendations to make their findings public, finds a study published by The BMJ today.

Post-authorisation studies (PAS) are carried out after a medicine is approved to collect further “real-world” data about its safety and effectiveness.

The results show that 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’s database.

Making post-authorisation study protocols and results publicly available is essential for scientific review, but there is currently a lack of data about how many EMA registered post-authorisation studies make their findings public.

To address this, researchers extracted data from the EMA Catalogue of real-world data studies in February 2024 to assess the availability of protocols for ongoing and finalised post-authorisation studies - and results for finalised post-authorisation studies - registered since November 2010.

EU legislation requires that protocols and results for category 1 and 2 studies in an EU Risk Management Plan (RMP) be uploaded to the EMA catalogue. The EMA also recommends uploading protocols and results for all other post-authorisation studies, including EU RMP category 3 studies, non-EU RMP-only studies, and studies not included in an RMP.

Overall, protocols were available for 1370 of 2300 (59.6%) ongoing and finalised post-authorisation studies and results were available for 1014 of 1482 (68.4%) finalised post-authorisation studies.

In ongoing and finalised post-authorisation studies, protocols were available for 76 (68%) of 112 EU RMP category 1 studies, 21 (64%) of 33 EU RMP category 2 studies, 419 (67%) 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.

In 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 (76%) of 401 EU RMP category 3 studies, 56 (69%) of 81 non-EU RMP-only studies, and 547 (64%) of 853 post-authorisation studies not included in an RMP.

Post-authorisation studies registered with the EMA insufficiently adhere to legislation and recommendations to upload the protocol and results to the Catalogue of real-world data studies, write the authors.

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, they add. Adherence also varied considerably between study sponsors.

These are observational findings and the authors acknowledge some limitations. For example, the study only provides a snapshot of the assessed adherence and relies on the timeliness of post-authorisation studies metadata entry.

Nevertheless, they conclude: “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.”

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