Public disclosure of clinical trial results

Open consultation(Closed): WHO ICTRP guidance for reporting summary results in clinical trial registries

Public registration of clinical trials, and the timely and full reporting of their results, are internationally accepted measures to promote transparency, identify existing trials, deter selective reporting, and increase the value of clinical research. The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) led the development of international norms and standards for trial registration in 2006, and later added elements on reporting of results in version 1.3 of the WHO Trial Registration Data Set.

There is substantial variation in the elements of summary results collected by trial registries. To promote harmonization, an ICTRP-led team has drafted recommendations for the minimum elements of study results that should be reported in trial registries. The purpose of this consultation is to solicit feedback from stakeholders - including researchers, patients, journal editors, funders, industry sponsors, and regulators - on key components of this draft guidance. The deadline for submitting feedback is 11 November 2022 (extended until 20 November 2022).

Please note we are providing a pdf of the full list of questions to help you plan your online submission – do not make a submission using the pdf, the submission should be through the online tool. Please feel free to contact us at ictrpinfo@who.int for additional information.

Joint statement on public disclosure of results from clinical trials

On 18 May 2017, some of the world’s largest funders of medical research and international non-governmental organizations agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly. Currently, about 50% of clinical trials go unreported, often because the results are negative. These unreported trial results leave an incomplete and potentially misleading picture of the risks and benefits of vaccines, drugs and medical devices, and can lead to use of suboptimal or even harmful products

• More details

WHO Statement on Public Disclosure of Clinical Trials Results

On April 14, 2015, the World Health Organization (WHO) published a new statement on the public disclosure of clinical trial results . The WHO statement defines reporting timeframes, calls for results-reporting of older but still unpublished trials, and outlines steps to improve linkages between clinical trial registry entries and their published results.

A public consultation process has been done previously on the original draft statement on public disclosure of clinical trials results and all the comments submitted were taken into consideration when the new statement was written.

• More details

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.