INTERNATIONAL RESEARCH FUNDERS AND NGOS PLANS TO IMPLEMENT WHO STANDARD IN REPORTING CLINICAL RESEARCH RESULTS.

In a joint statement by , 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,which includes world’s largest funders of medical research and international non-governmental organizations announced today  that they are planning on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.

They have  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. It was also informed that all results would be disclosed within specified timeframes on the registry and/or by publication in a scientific journal.

As per many surveys conducted world wide it was found that 50% of the clinical trials are not reported or not properly reprted ,because the results are negative.This will create 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. The signatories to the statement also agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting.

"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 WHO.

"We need timely clinical trial results to inform clinical care practices as well as make decisions about allocation of resources for future research," said Dr Soumya Swaminathan, Director-General of the Indian Council of Medical Research. "We welcome the agreement of international standards for reporting timeframes that everyone can work towards."

In 2015 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of results from clinical trials, which defines timeframes within which results should be reported, and calls for older unpublished trials to be reported.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.