The UK government will introduce a legal requirement to make public the results of all clinical trials within 12 months of trial completion. Any company or university breaking the law will be refused permission to start new trials, the UK drug regulator announced on Tuesday.
The UK government's new legal requirement will only cover drug trials, not all clinical trials. TranspariMED apologises for this error. The blog below has been left in its original, uncorrected form.
In addition, the new law will make it mandatory to pre-register trials and to share their outcomes with participants.
The UK already monitors centrally whether clinical trials are registered and their results are made public.
The UK law sets a new global benchmark for transparency in medical research. Comparable disclosure laws in the European Union and the United States only cover some types of trials, and so far remain unenforced.
Ensuring the rapid disclosure of all clinical trial results will benefit patients and taxpayers by curbing research waste, reducing the scope for evidence distortion, and accelerating medical progress.
The law will require all clinical trials to be registered on a public registry.
While this has been a UK regulatory requirement since 2013 in theory, that rule was not enforced in practice, and 8% of UK trials are currently still not being registered. Any exceptions (for example for commercially sensitive Phase 1 trials) will be granted only on a “case-by-case basis”.
Rapid results reporting
Publishing a “summary of results within 12 months of the end of the trial” will become a legal requirement.
Details have yet to be worked out, but it seems likely that this will involve uploading ‘tabular summary results’ onto a trial registry, mirroring European and American laws and WHO recommendations. The regulator notes that:
“Reporting of results is already expected best practice. The legislative requirements will formalise those expectations and there is clear consensus that it is important that all findings from research are published. The legislation will also make provision for the possibility of exemptions from the requirement where justified and agreed with the competent authorities, on a case-by-case basis.”
While drug trial results already have to be made public within one year, the new law will extend this requirement to trials of medical devices and all other non-drug interventions. This will substantially speed up science and accelerate the translation of new discoveries into improved patient care.
Sanctions with teeth
The UK regulator seems determined to enforce the law. If a company or university breaks the law, approval for new clinical trials will be refused:
“Non-compliance with new transparency requirements for trials (registration and reporting) will be specifically mentioned in the legislation, as constituting grounds for non-acceptance of a request for authorisation.”
This puts the UK lightyears ahead of the United States, where the FDA has yet to impose a single sanction on sponsors who violate a 2007 transparency law. Regulators across the European Union, who gained legal powers to enforce reporting requirements last year, are likely to take note.
Overwhelming public and expert support
The new legislative agenda follows a public consultation in which the over 2,000 respondents overwhelmingly supported new legislation to require trial registration (97%), rapid results reporting (94%), and sharing of trial findings with participants (91%).
According to the document:
“A significant majority of responders agreed with a legislative requirement to publish a summary of results. There was support for a clear timeline and agreement that legislation was necessary to improve the rate of publication. It was considered that this would improve public trust in research, reduce duplication in research and ensure publication of negative findings.”
What happens next?
The new law will be written by the UK’s drug regulator MHRA itself, following an unconventional legislative pathway adopted in the wake of Brexit. The details – for example the format in which results have to be reported – are yet to be decided.
According to the MHRA, “we will now take forward new legislation to update, improve and strengthen the UK clinical trials legislation… We will be preparing comprehensive guidance to accompany the legislation.”
A major victory for patients worldwide
The new law is a major victory for patients in the UK and sets a new global gold standard for transparency.
In future, people who volunteer to participate in trials in the UK will be able to trust that their efforts and sacrifices will not be wasted. More broadly, patients, doctors and researchers worldwide will benefit from new discoveries ‘made in UK’ being rapidly and transparently shared.
Where do we go from here?
It took ten years for the UK to finally get here – starting in 2013 with Ben Goldacre and the AllTrials campaign, continuing in 2018 with Norman Lamb and his parliamentary enquiry, and continuous pressure for reform throughout the years by Universities Allied for Essential Medicines, Cochrane, Transparency International, HealthSense, JustTreatment, Sling the Mesh, TranspariMED, and many other groups.
Let’s keep working together and make sure that other countries follow the UK’s positive example – and do so soon.
Clearly, this can be done. Let’s get it done.
Note: The new UK law will also streamline and accelerate the approval process through parallel regulatory and ethics reviews of clinical trial applications, and simplify approvals and lower consent requirements for low-risk and cluster trials, among many other things. Anyone interested in clinical trial regulation should read the entire document.