Publish your clinical trial results in ToetsingOnline and in EudraCT database

Sponsors are required to publish results of research subject to the WMO (Medical Research involving Human Subjects Act) in ToetsingOnline and, in the case of research with a medicinal product, also in the EudraCT database.

This news item was prompted by a joint letter from the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), to remind sponsors that, as of July 2014, they are legally required to publish results of research with a medicinal product conducted in the European Union, in the EU Clinical Trials Database (EudraCT) within one year of the end of a clinical trial. In addition, CCMO would like to draw your attention to the fact that the results of all research subject to WMO must also be submitted to ToetsingOnline.

In the EudraCT database, study results were still lacking in 31.8% of the completed studies, whereas the results should have been posted by the sponsors involved. The reporting compliance of non-commercial sponsors (e.g. academia) was much lower than for commercial sponsors (i.e. companies), with 23.6% of results posted for non-commercial sponsors versus 77.2% for commercial sponsors. As academic sponsors or smaller companies often lack awareness or incentives to post clinical trial results, EU authorities are taking various steps, among others the letter to stakeholders regarding the requirements to provide results for authorised clinical trials in EudraCT, to ensure sponsors are aware of their obligations and can act on them.

The CCMO website gives further details on the publication of clinical trial results in ToetsingOnline, and in the case of research with a medicinal product, also on publication of results in the EurdraCT database. Results submitted to ToetsingOnline will be made public in the CCMO register, unless the sponsor has objected to publication in the register. Results published in the EudraCT database will become publicly available in the EU Clinical Trials Register.