The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure of
clinical trials in public databases has progressed to a new level, encompassing not only registration of new trials but also the disclosure of summary results for completed clinical trials for all drugs investigated in clinical trials, irrespective of their marketing approval status. Further development currently being implemented is the sharing of de-identified/anonymised trial participant data sets, thereby enabling re-analysis.
The Regulation EU No. 536/2014 is an EU law that instructs trial sponsors on the organisational, reporting, and disclosure aspects of clinical trials. The content of Regulation EU No. 536/2014 is intertwined with other obligations relevant to clinical trial disclosure and transparency efforts. Overlaps of the Regulation EU No. 536/2014 to other pertinent laws, policies, or required practices are summarised in this article, and some
practical examples are provided for stake - holders who are involved in the planning, evaluation, and preparation of documents relevant to clinical trials.