In a move that will increase transparency and accountability in clinical research, major research funders and international NGOs agreed to implement standards in line with WHO's recommendations
About 50 per cent of clinical trials go unreported, often because the results are negative, says the World Health Organization (WHO). 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.
In a move to prevent such misinformation and increase the availability of clinical trial results, some of the world's largest research funders and international non-profits recently agreed to implement standards which will require all clinical trials they fund or support to be registered and the results disclosed publically.
Dr Soumya Swaminathan, Director-General of the Indian Council of Medical Research (ICMR), which is one of the signatories, said, " We need timely clinical trial results to inform clinical care practices as well as make decisions about allocation of resources for future research. We welcome the agreement of international standards for reporting timeframes that everyone can work towards."
Apart from ICMR, 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 year which will require that all trials they fund, co-fund, sponsor or support will be registered in a publically-available registry. The results would be disclosed within specified timeframes on the registry and/or by publication in a scientific journal.
The signatories have also agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting.
Dr Jeremy Farrar, Director of the Wellcome Trust said in a release, "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."
The trials will be available on WHO’s International Clinical Trials Registry Platform.
Dr Trevor Mundel, President, Global Health, Bill & Melinda Gates Foundation, said, “It's a 21st-century best practice – and an essential part of the social contract that underlies medical research – that clinical trial data should be made publicly available less than one year after a clinical trial's completion. We strongly support WHO's effort to establish a global standard for reporting data within this timeframe, which is a practice we require of our grantees as well."
This agreement largely subscribes to the WHO's public position on clinical trial reporting published in 2015, which builds on World Medical Association’s Declaration of Helsinki in 2013.
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The ICMR has agreed to make public results of clinical trials they support, fund, co- fund or sponsor. Credit:National Institute of Allergy and Infectious Diseases/Flickr .png)
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