International Clinical Trials Registry Platform (ICTRP)

Call for public consultation: WHO Statement on Public Disclosure of Clinical Trial Results

For the next 30 days the World Health Organization welcomes a public consultation on the official WHO statement regarding public accessibility of clinical trial results. During the consultation period the public can send their feedback on the WHO statement to make all clinical trial results openly accessible. This measure comes after the WHO established the International Clinical Trials Registry Platform to improve research transparency, but found that more work was needed to ensure that trials were registered and their results made available. The WHO statement supports the disclosure of clinical trial results to enhance transparency for the public.

Please download attached comment form and enter comments into the Word file. Email completed comment forms to: ictrpinfo@who.int. The deadline for comments is 15/11/2014

Reporting of Findings of Clinical Trials

When researchers embark on a clinical trial, they make a commitment to conduct the trial and to report the findings in accordance with basic ethical principles. This includes preserving the accuracy of the results and making both positive and negative results publicly available. However, a significant proportion of healthcare research remains unpublished and, even when it is published, some researchers do not make all of their results available. Selective reporting, regardless of the reason for it, leads to an incomplete and potentially biased view of the trial and its results. For more information please refer to "Reporting the Findings of Clinical Trials" in The Bulletin.

First Draft WHO Statement on Public Disclosure of Clinical Trials Results

Following a ministerial summit on Health Research in 2004, a World Health Assembly Resolution passed in 2005 called for unambiguous identification of all interventional clinical trials. This led to the establishment of the WHO International Clinical Trials Registry Platform, which collates information on trials that have been notified in a network of clinical trial registries. WHO’s existing position on registration can be found on the ICTRP website.

Concerns have been raised that there may be selective publication of trials dependent on their results, with particular concern that trial results which may be viewed as “negative”, are less likely to be submitted, or accepted, for publication in the scientific literature or made public in other ways.

In the latest version of the Declaration of Helsinki it is stated that “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.” and that “Researchers have a duty to make publicly available the results of their research.” There is an ethical imperative to report the results of all clinical trials. The draft WHO statement related to public disclosure of clinical trial results is now open for public consultation over the next 30 days. Following this period the statement will be finalized, and will become WHO’s Position with regard to reporting of clinical trial results.