The EMA today made it easier to upload the results of prematurely ended clinical trials onto the European trial registry EudraCT.
According to the EMA website:
Sponsors of trials that are "prematurely ended" can now post results in EudraCT as a pdf document.
- For trials that were approved but never started, sponsors are required to state the reasons for the premature interruption in the pdf document
- For trials that started and terminated early, sponsors are required to state the reasons for the early interruption, together with any partial result, if available, in the pdf document
An EMA staff member explained by email that:
“After having uploaded a pdf document in their results page, when clicking on ‘post results’, the system asks if the trial has prematurely ended. If sponsors click on ‘yes’, the system allows them to post a pdf file for their partial results.”
In future, reporting the outcomes of prematurely ended trials should be easy, comparable to uploading the results of trials completed before 2013.
The news will be welcomed by universities across Europe, which have for many years struggled to circumnavigate a bug in the system.
TranspariMED applauds the EMA for fixing this bug, which comes on the heel of other significant steps by EMA to make trial reporting easier for universities, including the streamlining of processes and the setting up of a functional help desk.
TranspariMED and the EBM Data Lab at the University of Oxford had lobbied the EMA to make this change.
Universities that wish to improve their clinical trial reporting are encouraged to review TranspariMED’s collection of transparency tools.