UK parliament calls on government to impose ‘tough sanctions’ for unreported clinical trials
The Science and Technology Committee of the UK’s House of Commons today issued a report calling on the government to launch a “national audit programme of clinical trials transparency” and impose sanctions on institutions and individuals who fail to register trials or report their results.
Norman Lamb MP, Chair of the Science and Technology Committee, said:
“An astounding amount of information from clinical trials is going unreported. The HRA [Health Research Authority] must act now to ensure current regulations are enforced and impose tough sanctions on those who seem to think it is acceptable to disregard valuable research, threaten research integrity and, in some cases, endanger human life. Many of these trials are funded with public money and the tax payer has a right to expect those who benefit from public funding to follow the rules and publish in full.… The HRA must be provided with all of the necessary funding it needs to produce an official list of which trials have reported results and which ones haven’t.”
If adopted by the government, the Committee’s recommendations will ensure that every single clinical trial conducted within the UK is registered and publishes its results.
In a rapid reaction, the Health Research Authority stated that it will now consider imposing sanctions:
"[T]he HRA will now look how we could take a more robust approach, including potential sanctions, for example not providing ethical approval to new studies until existing ones have been registered in line with the current guidance. We welcome the recommendation in today’s report that our current transparency work be brought together into a formal and detailed strategy during the coming year... We also welcome a discussion with the Department of Health and Social Care to explore the financial and statutory implications of the HRA taking on a more robust role in ensuring complete reporting and transparency. We will act on the recommendations published by the select committee today, and report on our progress."
Key passages:
NEED FOR POLITICAL LEADERSHIP
"Clinical trials transparency is as much a question of political will as it is a technical issue. We recommend that the Government explicitly re-commit to tackling clinical trials transparency, perhaps through a focused ministerial speech on this issue. This should set a clear time limit for institutions to fully comply with clinical trials transparency requirements and make clear what the consequences will be of failing to meet that deadline... We recommend that the Government ask the HRA to publish, by December 2019, a detailed strategy for achieving full clinical trials transparency, with a clear deadline and milestones for achieving this."
NATIONAL AUDIT PROGRAMME
"We recommend that the Health Research Authority (HRA) should be provided with funding to establish a national audit programme of clinical trials transparency, including the publication of a single official list of which UK trials have published results and those which are due to but have not… the results should be published trial-by-trial rather than simply at the summary level."
SANCTIONS FOR NON-REPORTING
"[W]e recommend that the HRA introduce a system of sanctions to drive improvements in clinical trials transparency, such as withdrawing favourable ethical opinion or preventing further trials from taking place. The Government should consult specifically on whether to provide the HRA with the statutory power to fine sponsors for non-compliance… We recommend that the Government consult further with the HRA on whether it is capable of delivering the improvements to clinical trials transparency needed within its current remit. If necessary its remit should be extended through introducing legislation which amends the provisions of the Care Act 2014… The Government should explicitly commit to introducing the clinical trials transparency requirements in the EU Clinical Trials Regulation that are expected to be applied in the EU shortly after Brexit."
UNIVERSITY-SPONSORED TRIALS
"Every university should aim for 100% compliance… We recommend that the updated and strengthened Concordat to Support Research Integrity being developed by Universities UK should include requirements on universities to ensure that all trials are reported, and that efforts are made to share best practice in achieving compliance with reporting rules within the university sector."
TRIALS SPONSORED BY NHS TRUSTS
"It is particularly disappointing that trusted bodies such as Public Health England and a range of NHS Foundation Trusts are also failing to report results from clinical trials. Public trust in medicine could easily be eroded by failures in clinical trials transparency from such important parts of the health system. Public Health England should write to us with an explanation and the steps it will take to correct this."
COSTS VERSUS BENEFITS OF MONITORING COMPLIANCE
"Even if the cost of fully assessing reported trial outcomes against the original specification in the application for ethical approval amounts to £2.4m per year, as the HRA suggested in evidence to us, this is a small price to pay compared with the sums of money involved in policy decisions that draw on clinical trials evidence, such as the £424m the Government spent on stockpiling Tamiflu without full access to evidence on its effectiveness… If further financial resource for the HRA is required to tackle clinical trials transparency then the Government should consider favourably such requests."
The Committee’s recommendations fully incorporate the policy proposals made by TranspariMED, which jointly with Universities Allied for Essential Medicines, HealthWatch UK and STOPAIDS made three separate submissions of evidence in the course of the Committee’s enquiry.
Till Bruckner, founder of TranspariMED, said:
"Failure to publish trial results is not a victimless crime: both patients and taxpayers pay a steep price. A few years ago, the NHS misspent £424 million on Tamiflu because the results of eight clinical trials had remained hidden. The HRA's response to the report is extremely encouraging. Now the government must give the HRA the resources and powers it needs to ensure that all trials involving UK patients are registered and fully reported. As parliament has pointed out, fixing this problem is not only possible, it is also far cheaper than continuing to ignore it."
Rachel Cooper, Director of Transparency International Health Initiative, said:
“Once again the UK Parliament has found serious failings in the lack of transparency over clinical trials and this time those warnings cannot afford to be ignored. Transparency over clinical trials is vital to ensure patients are receiving appropriate care and the benefits and risks have been properly considered. The public must be able to trust the medical products they are taking are going to improve their health and likewise that public money is being used in the right way.”
Saoirse Fitzpatrick, Senior Advocacy Adviser for STOPAIDS, said:
"STOPAIDS welcomes this report and urges the government to act on its recommendations. The lack of transparency within our current health research and development model is hurting science and our potential to deliver innovations of true public value. For an area of research that relies so heavily on public financing, the public have a right to know the outcome of that research and to benefit from it."
The UK government now has to produce a written response to the Committee within two months.
The SciTech Committee's report has been coverd widely by the UK media, including the BBC, The Times, Times Higher Education, and the Press Association. Public Health England stated that it was already "in the process of uploading our results data".
TranspariMED will continue to remain engaged with the process to ensure that the issue stays on the political agenda.