The FAMHP reminds all sponsors they are obligated to publish the results of their clinical trials in the European Clinical Trials Database (EudraCT) within one year after the end of trial date (or six months for a paediatric trial). Publication on external sources or the transmission of reports to national competent authorities is not sufficient. The guideline applies retrospectively.
Results should be posted in the EudraCT database as soon as possible in order to comply with the European Commission Guideline for publication of results and as requested in the Joint Letter by the European Commission, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA).
This obligation was specifically incorporated in the Informed Consent Form (ICF) template, but it has become clear that not all sponsors of clinical studies are compliant with this obligation. The FAMHP strongly encourages all sponsors of clinical trials conducted on Belgian territory to comply with this obligation, as the lack of transparency has serious implications for patients, healthcare professionals and healthcare systems.
Legal background
Publishing the clinical trial summary results in the European Clinical Trials Database (EudraCT) became mandatory for sponsors as of 21 July 2014. Sponsors of trials that were "ended prematurely" can also post results in EudraCT as a PDF document.
Article 36 of the 2013 Helsinki Declaration explains the need to publish all clinical trial results: “Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.”
How to ensure the publication of clinical trial results?
All national competent authorities have received the reports from the European Medicines Agency (EMA of completed trials in EudraCT for which results in their Member State are overdue. The FAMHP will contact all sponsors of clinical trials that have been conducted and completed in Belgium for which no results have been uploaded in EudraCT. In addition, the progress of the trials have not yet been compliant with this obligation will be monitored.
More information on how to post results:
- for clinical trials for which the results have not been posted in EudraCT;
- for clinical trials for which the results are still in ‘draft’ in EudraCT.
Incomplete clinical trials
For trials that have been approved but never started, sponsors are required to state the reasons for the premature termination in the PDF document. For trials that have been started but terminated prematurely, sponsors are required to state the reasons for the early termination, along with any partial result, if available, in the PDF document.
Sponsors are encouraged to publish the results for all trials as soon as possible.
In addition, the sponsors of clinical trials that have already ended but for which the end of trial date has not yet been communicated to the FAMHP, are strongly encouraged to do so and to publish their results following the rules mentioned above.
Status of the clinical trial
Finally, in order to avoid inconsistent data for their trials in EudraCT (e.g. a global end of trial date has been entered by one of the national competent authorities while in Belgium it appears that the trial is still ongoing), sponsors are recommended to verify the status of all their terminated trials in EudraCT. If inconsistencies are identified, the sponsor can resolve these by submitting a “Declaration of the end of trial form” to the FAMHP. The trial data will automatically be updated in EU Clinical Trials Register as well. On the other hand, the information on the results is updated directly by the sponsor. In case of mistakes, the sponsor can upload an updated version of the results and post them. This last version will appear in EU Clinical Trials Register two weeks after posting.
More information
- How to conduct a clinical trial?
- How to publish results of a clinical trial in EudraCT?
- Validation rules for clinical trial results
- Search examples on how to report on clinical trials
- Select “search tools”
- Fill in “select date range” between 1st August 2013 and today
- Select “results status” as “trials with results”
- Click on “search”
- FAQ on the EudraCT database and European Clinical Trial Register (EU CTR)
- EudraCT data dictionary
Contact
- Create a new EMA account.
- Contact the EMA Service Desk for specific problems that cannot be solved with the validation rules or the links stated above. Please mention the clinical trial number or attach the XML file of the results (click on "download XML" at the top right corner of your trial's page).