Transparency in clinical trials: registration & reporting of study results
Transparent clinical research is crucial to the accessibility and usefulness of the underlying clinical work. Clinical trials should be transparent from prior to initiation (i.e. registration) to after study completion (i.e. reporting).
Many universities in the EU are failing to upload all their clinical trial results onto registries, leading to research waste and incomplete outcome reporting. We encourage participants to search the EU Trials Tracker for their institution’s clinical trial data.
Universities and other non-commercial trial sponsors in Germany and other EU countries are becoming increasingly aware of their obligation to upload the results of clinical trials onto the European trial registry EudraCT. Pressure to do this increases with continued advocacy by campaign groups and new EU Clinical Trial Regulations.
However, universities are often unclear about how to a) upload the results of (old) trials, and b) set up systems that ensure timely results posting going forward. This creates a barrier to improved performance.
Manual, Events, CTIS
Manual
The QUEST Center has developed a hands-on manual drawing together the experiences and lessons learnt by front-runner universities that have successfully tackled the problem. The manual focusses on steps taken at the institutional level; it does not contain a guide to using EudraCT.
Events
The QUEST Center also organises events on this topic. Please find helpful material under the following event links:
Clinical trail reporting workshop (29. September 2019, in Englisch)
Summary and presentations of the workshop
Workshop on uploading clinical trial results onto EudraCT (9. November 2021, in Englisch)
Workshop presentations:
- Nicholas J. DeVito, University of Oxford - Your data on the EU Trials Tracker: how it works and how to use it
- Birgit Whitman, University of Birmingham - Trial portfolio
- Francesca Scotti, European Medicines Agency - EMA online training materials
- Tony Durkee, Karolinska - Useful resources – the QUEST manual and QUEST workshop slides
Videos of the presentations:
- Nicholas J. DeVito, University of Oxford - Your data on the EU Trials Tracker: how it works and how to use it
- Birgit Whitman, University of Birmingham - Trial portfolio
- Francesca Scotti, European Medicines Agency - EMA online training material
Clinical trial results reporting on EudraCT made easy webinar (17. Februar 2022, in Englisch)
Recording of the Webinar (Focus: Posting results for trials completed before 21 July 2013 or trials that were ended prematurely)
Clinical Trials Information System (CTIS)
As of January 31, 2022 all clinical trails are administered by a central portal of the EMA called clinical Trails Information System (CTIS). A short overview on the respective Regulation (EU) No 536/2014 og the European Parliament and of the Council and the CTIS can be found here. (Charité Intranet, in German).
CTIS-Quiz
On the website of the EMA you can find training modules. If you want to test your knowledge on the CTIS, you can do this via this quiz. The quiz was developed by the QA-Unit Clinical Studies of the Charité for Charité researchers and translated/adapted by the QUEST Center.
