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Global standards on reporting clinical trial results agreed

Rules to tackle 50% of trials that are currently unreported

Adrian O’Dowd

Thursday, 18 May 2017

The large majority of clinical trials will have to be published in the future following a landmark agreement.

A group of the world's largest funders of medical research and international non-governmental organisations (NGOs) have agreed on new standards requiring all clinical trials they fund or support to be registered and results made public.

The joint statement was issued by the UK Medical Research Council, Indian Council of Medical Research, Norwegian Research Council, the Médecins Sans Frontières research arm Epicentre, PATH, the Coalition for Epidemic Preparedness Innovations (CEPI), Institut Pasteur, the Bill & Melinda Gates Foundation, and the Wellcome Trust.

Currently, it is estimated that around 50% of clinical trials go unreported, often because the results are negative. The organisations will develop and implement policies within the next 12 months requiring all trials they fund, co-fund, sponsor or support to be registered in a publicly-available registry.

In addition, they agreed all results would be disclosed on the registry and/or by publication in a scientific journal by an agreed deadline. The standards have been drawn up by the World Health Organization (WHO), which has said unreported trial results leave an incomplete and potentially misleading picture of the risks and benefits of vaccines, drugs and medical devices, and could lead to use of suboptimal or even harmful products.

In 2015, WHO published its position on public disclosure of results from clinical trials, which defines timeframes within which results should be reported, and called for older unpublished trials to be reported. The new agreement by some of the world's major research funders and international NGOs will mean the ethical principles described in the 2015 statement will now be enforced in thousands of trials every year. The organisations have also agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting.

Most of these trials and their results will be accessible via WHO's International Clinical Trials Registry Platform, the global database of clinical trials that compiles data from 17 registries around the world, including the EU's Clinical Trials Register, the USA's clinicaltrials.gov, the Chinese and Indian Clinical Trial Registries and many others.

Dr Marie-Paule Kieny, assistant director-general for health systems and innovation at WHO, said research funders had made a strong statement that there will be no more excuses for some clinical trials remaining unreported long after completion.

Dr Jeremy Farrar, director of the Wellcome Trust, said: 'Requiring summary results of clinical trials to be made freely available through open access registries within 12 months of study completion is good for both science and society.

'Not only will this help ensure that these research findings are more discoverable, but it will also reduce reporting biases, which currently favour publication of trials which have a positive outcome. Today's statement is in line with Wellcome's broader ambition to make all research outputs which arise from our funding more findable, accessible, and re-usable.'

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