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May 18, 2017

Medical research funders and NGOs agree on new WHO clinical trial policies

The majority of medical research funders and international non-governmental organisations (NGOs) have agreed to implement the new World Health Organisation (WHO) standards for clinical trials.

The majority of medical research funders and international non-governmental organisations (NGOs) have agreed to implement the new World Health Organisation (WHO) standards for clinical trials.

The firms include Indian Council of Medical Research, Norwegian Research Council, UK Medical Research Council, Médecins Sans Frontières and its research arm Epicentre, PATH, Coalition for Epidemic Preparedness Innovations (CEPI), Institut Pasteur, Bill & Melinda Gates Foundation and Wellcome Trust.

According to the new policies, all the trials funded or supported by these organisations have to be registered and their results should be reported publicly.

Within the coming 12 months, the firms will develop and implement policies requiring the registration of all trials they fund, co-fund, sponsor or support, in a publicly available registry.

At the same time, the trial results have to be reported on the registry in specified time frames and/or should be published in a scientific journal.

The main objective of the new standards is to avoid the availability of potentially misleading information on the risks and benefits of vaccines, drugs and medical devices, due to unreported results.

"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."

WHO Health Systems and Innovation assistant director-general Dr Marie-PauleKieny said: "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.”

The firms also agreed to monitor compliance with the policies, as well as endorse the system development for result report monitoring.

The principles mentioned in 2013 World Medical Association’s Declaration of Helsinki, as well as in WHO’s 2015 publication on the disclosure of results and timeframes, will now be implemented in the trials.

WHO’s global database of clinical trials called International Clinical Trials Registry Platform, which compiles data from 17 registries, will carry the information on these trials and their results.


Image: WHO headquarters in Geneva, Switzerland. Photo: courtesy of Thorkild Tylleskar.

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