On April 14, 2015, the World Health Organization published a new statement on the disclosure of clinical trial results. In the latest version of the Declaration of Helsinki it is stated that “Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research”. Failure to report the results of clinical research leads to grave consequences.
The WHO statement defines reporting time frames. Clinical trial results are to be reported according to the time frames outlined below.
Reporting is to occur in BOTH of the following:
- The main findings of clinical trials are to be submitted for publication in a peer reviewed journal within 12 months of study completion and are to be published through an open access mechanism unless there is a specific reason why open access cannot be used, or otherwise made available publicly at most within 24 months of study completion.
- In addition, the key outcomes are to be made publicly available within 12 months of study completion by posting to the results section of the primary clinical trial registry. Where a registry is used without a results database available, the results should be posted on a free-to-access, publicly available, searchable institutional website of the Regulatory Sponsor, Funder or Principal Investigator.
For further reading: WHO | WHO Statement on Public Disclosure of Clinical Trial Results.