The AllTrials campaign, which has been calling for all clinical trials past and present to be registered, and full methods and results made available, today welcomed new proposals by the US Department of Health and Human Services (HHS) and National Institutes of Health (NIH) to expand reporting of clinical trial results, and to make that a condition of research funding, as a significant and potentially transformative step in the battle for clinical trial transparency.

Around half of all clinical trials for treatments we use today have never published results and thousands have never even been registered. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. Hundreds of thousands of patients took part in those trials in the expectation that their results would be used by doctors and researchers to improve understanding of disease and the development of new treatments.

HHS has launched a consultation on expanding the scope of the FDA Amendment Act 2007 to include requirements that clinical trials of unlicensed medicines and for off-label uses be registered and report results on ClinicalTrials.gov. NIH has launched a concurrent consultation on requiring all clinical trials it funds to be registered and report results, regardless of whether they are subject to FDAAA.

Trevor Butterworth, director of Sense About Science USA, which is leading the AllTrials campaign in the US:

The thousands of individuals and organisations who have signed up to AllTrials.net—to demand that all clinical trials be registered and all results be reported—will applaud these bold and forward-thinking proposals. The voices of patients, doctors and researchers are being heard: report what you find when you do a trial; report everything. Not to do so betrays patients, thwarts research, and undermines society’s faith in medicine and science. History is moving, and in this move, HHS and NIH are giving companies and research bodies the chance to be on the right side of it.

Dr Ben Goldacre, author of Bad Pharma and co-founder of the AllTrials campaign:

The problem of withheld trial results has been perpetuated by half-fixes for too long. There are three positive aspects to this week’s announcement.

Firstly, greater transparency around any arguments or permissions for late disclosure of results will allow better audit of who is failing to comply, better intelligence for clinicians and patients on which treatments may be less trustworthy due to distorted or missing data, and more transparency on how the regulations are being applied in practice.

It is also good to see recognition of the importance of transparency for trials on unlicensed uses of currently available treatments, outside of their current marketing authorisations. Such uses are extremely common in routine clinical practice, and regardless of the laws governing promotional activity by drug companies, it is clear from a long and repeated series of legal cases that use outside the marketing authorisation is also routinely promoted by pharmaceutical companies. It is therefore senseless and dangerous for trials on such uses to be exempted from robust reporting requirements.

Lastly it is extremely encouraging to see NIH showing leadership on improving reporting rates for the trials they fund themselves. Although industry have made themselves the target of public concern around withheld data, by actively campaigning and lobbying against transparency, trials are also routinely withheld from doctors, researchers, and patients by non-industry sponsors and researchers. NIH is in a strong position to shift the cultural norms around this dangerous practice, and other funders should follow their lead.

Please add your voice in support of these proposals before 19th February 2015 23rd March 2015. Both consultations are open to everyone, not just US citizens.

Write in support of the HHS proposal to expand the scope of the FDA Amendment Act 2007 here. You can read some of the public comments that have already been submitted here.

Email clinicaltrials.disseminationpolicy@mail.nih.gov to support the NIH proposal to make registration and reporting a condition of funding.

We will share our responses with you as soon as we can.

Update (11th February 2015): The consultation deadlines have been extended until 23rd March 2015.

 

Additional comments:

Kay Dickersin, US Cochrane Center Director:

It is good news that more trials will be registered and their results posted. It is disappointing that the rulemaking clarifies that protocols should not be submitted to ClinicalTrials.gov, as it should at least be allowed that a trial protocol can be submitted voluntarily. I would urge them to review this.

Harlan Krumholz, Director of the Yale Open Data Access Project:

For the conduct of research to improve, calls for transparency and reporting and sharing need to become mainstream and be promoted by our most respected and influential organizations. NIH’s decision to exert its influence to solve the problem of non-reporting, especially in academia, is welcome leadership by an organization that can get the job done. They have introduced a proposed rule for public comment and, with a big push, the final rule could even be stronger. It is a moment to applaud their efforts and support them to close the deal. Then we need to focus intently on data sharing.

Francis S. Collins, NIH Director:

Medical advances would not be possible without participants in clinical trials. We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld.

Margaret A. Hamburg, FDA Commissioner:

This proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices and biological products available to the public. It would help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products.

Brian Glanz, Director, Open Science Federation:

For lack of action in Congress, the Obama Administration continues to lead on Open Government and Open Science, from OSTP to the NIH, HHS, FDA, and well beyond. We applaud the proposed NIH and FDA rules to openly publish the results of all clinical trials, but we still need Congress to get involved. Only better law can enforce and sustain these rules. Congress must meet its responsibility to protect Americans’ health and safety, by fixing the loopholes that are used to hide publicly funded medical research.

We want nothing less than all clinical trials to be reported on ClinicalTrials.gov. “All trials” includes phase I trials, negative results, trials done outside the US, and more — all trials. We want the data, not only summary reports. And we want those publicly-funded data to be in the public domain, so we can make the most out of our investments.