Summary clinical trial results

You are required to submit a summary of the clinical trial results to the review committee (MREC or CCMO) within one year of the end of the trial (worldwide). You may submit a scientific publication or a summary of clinical study report. A pdf can be uploaded in the web portal ToetsingOnline. The results of the study will be published in the CCMO register after 15 days, unless the sponsor has objected with arguments.

In case of research with a medicinal product you are also required to submit a summary of the clinical trial results to the competent authority within one year of the end of the study (worldwide).

A template for a summary of a clinical trial report for research with a medicinal product can be found in annex 1 of the ICH E3 Guideline on the contents and structure of clinical study reports (CPMP/137/95).

The CCMO statement publication policy gives the viewpoint of the CCMO on how they think the publication of clinical trial results should be carried out.

Research with a medicinal product: clinical trial results in EudraCT and the EU Clinical Trial Register

For clinical research with medicinal products which falls under Directive 2001/20/EC the sponsor needs to add the study results to EudraCT. This initiative is based on the European Commission Guideline concerning posting and publication of result-related information on clinical trials, theĀ European Commission Guideline 2012/C 302/03. The results for most trials must be reported within 12 months after the end of the study.

The study results will be published in the publicĀ EU Clinical Trials Register 15 days after a valid report in EudraCT, with the exception of most phase I trials. If the sponsor has not reported the results timely in EudraCT the study will be highlighted, which will be visible in the EU Clinical Trials Register.

Sponsors need to register on the EudraCT website to be able to add the study results to EudraCT.

More information can be found at the website of EMA.