Since the European Medicines Agency (EMA) started implementing a new transparency policy in October 2016, it has published large quantities of clinical data submitted in connection with marketing authorisation procedures from 2015 onwards (1,2). These data are published on the EMA's website in the form of "data packages", each containing numerous documents, including clinical study reports. The EMA had committed to publishing these data within 60 days of granting marketing authorisation (2). In a study published in 2021, a group of researchers demonstrated that clinical study reports constitute a source of data on drugs that can mitigate the bias caused by the fact that some results are never reported in the scientific press or clinical trials registers (3). In 2022, the same group sought to ascertain whether the EMA was adhering to its 60-day deadline for publication, focusing in particular on clinical study reports (2).
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