Some of the world’s largest research funders and NGOs today agreed to adopt the WHO’s strong standards on clinical trial transparency. This means all clinical trials they fund or support will be registered and the results reported.
In a joint statement, nine major funders including Médecins Sans Frontières, the Bill & Melinda Gates Foundation, the Indian Council of Medical Research, the Norwegian Research Council, the UK Medical Research Council and the Wellcome Trust committed to develop and implement policies that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available register. They also agreed that all trial results would be disclosed within specified timeframes on the register or by publication in a scientific journal.
Around half of clinical trials carried out around the world have gone 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 sub-optimal 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 WHO.
The signatories to today’s statement also agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting.
“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of results from clinical trials, which defines timeframes within which results should be reported, and calls for older unpublished trials to be reported.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.
“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,” said Dr Jeremy Farrar, Director of the Wellcome Trust. “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.”
Most of these trials and their results will be accessible via WHO’s International Clinical Trials Registry Platform, a unique global database of clinical trials that compiles data from 17 registries around the world, including the USA’s clinicaltrials.gov, the EU’s Clinical Trials Register, the Chinese and Indian Clinical Trial Registries and many others.
Dr Ben Goldacre, one of the founders of the AllTrials campaign said:
This is truly fantastic news. We cannot make informed choices about which treatments work best when the results of completed clinical trials are routinely withheld from doctors, researchers and patients. The scandal of unreported clinical trials has arisen because of a longstanding failure to take responsibility, throughout the whole ecosystem of medicine.It is a huge relief to see government research funders now taking a lead. If every funder does what they commit to in this clear policy statement, they will not just be making promises, they also commit to engaging in a thorough process of open audit, so that everyone can see whether they have complied with their own transparency policies. This is a great day for patients, and for the reputation of medicine.
This is great news. It’s great news for the patients who volunteered for clinical trials that have never published results; for researchers re-running trials that they don’t know already happened; and great news for all of us who expect our doctors to know whether our medicines work.
It’s especially important to see the signatories calling for the development of systems to monitor whether results are being shared. We need ways to monitor which results are missing. This will help us celebrate the organisations who are finding ways to share results, and to call out those who are letting us down.
April Clyburne-Sherin, campaign manager at AllTrials USA said:
This group of funders and non-governmental organizations is leading the way in a much needed move from awareness to action. Registration and reporting policy, compliance monitoring, and enforcement is now the Gold Standard by which other clinical trial funders and organizations will be measured. Other clinical research organizations should see this as an opportunity to raise their standards to match. This is a turning point in our conversation about the problem of missing clinical trials. Today is the day leaders in the clinical trial community embraced a new status quo where all trials are registered and all results are reported.
Lisa Bero, Cochrane board co-chair said:
“The adoption of the WHO standards by major funders and NGOs sends a clear signal that all results from clinical trials should be publicly available. We hope that others also will adopt these standards and we look forward to seeing regular progress reports on the implementation of this policy.
Cochrane Review authors often struggle to obtain the unpublished results of trials, so this commitment will provide valuable data. Going forward, it will be useful to have detailed standards for results reporting for all trial outcomes to ensure that usable data are available for systematic reviews. Ensuring that clinical trials results are available empowers policy-makers, clinicians, and individuals have the best available information to make informed choices about health and health care.”
Dr Micaela Serafini, Medical Director, Médecins Sans Frontières said:
“Timely reporting of all clinical trial results is of upmost importance to MSF allowing fully informed decisions when it comes to health strategies, treatments and diagnostics. We fully support this move towards increased transparency and accountability in clinical research.”
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.”
Dr. David C. Kaslow, Vice President of Essential Medicines at PATH said:
“PATH remains deeply committed to the timely public disclosure of clinical trial results to accelerate development of new interventions and to ensure access to and transparency of safety and efficacy data, no matter if positive or negative. Full and consistent implementation of WHO standards on reporting clinical trial results is an important step towards better understanding the risks and benefits of vaccines, drugs and medical devices, and the optimal use of new interventions.”
If any research funders, charities, not for profit NGOs, or government entities overseeing clinical trials wish to join the statement, they can contact Vaseeharan Sathiyamoorthy at email@example.com
Watch Síle Lane’s Tedx talk on the cost of hidden clinical trials.