Major research funders and NGOs to implement WHO standards on reporting clinical trial results

Some of the world’s largest funders of medical research and international non-governmental organizations (NGOs) today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.

In a joint statement, the Indian Council of Medical Research, the Norwegian Research Council, the UK Medical Research Council, Médecins Sans Frontières and Epicentre (its research arm), PATH, the Coalition for Epidemic Preparedness Innovations (CEPI), Institut Pasteur, the Bill & Melinda Gates Foundation, and the Wellcome Trust agreed to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available registry. They also agreed that all results would be disclosed within specified timeframes on the registry and/or by publication in a scientific journal.

Link to joint statement: www.who.int/ictrp/results/jointstatement/en/

Today, about 50% of clinical trials go unreported, according to several studies, 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.

“Research funders are making a strong statement that there will be no more excuses on why some clinical trials remain unreported long after they have completed,” said Dr Marie-Paule Kieny, assistant director general for Health Systems and Innovation at the World Health Organization (WHO).

The signatories to the statement also agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting.

In 2015, the WHO published its position on public disclosure of results from clinical trials, which defines timeframes within which results should be reported, and calls for older unpublished trials to be reported. That position builds on the World Medical Association’s Declaration of Helsinki in 2013. Today’s agreement by some of the world’s major research funders and international NGOs will mean the ethical principles described in both statements will now be enforced in thousands of trials every year.