MPs have expressed concern that nearly half of clinical trials in the UK fail to publish their results, “presenting risks to human health and increasing research wastage”.
The Science and Technology Committee says it is concerned that selective non-publication - ‘or publication bias’ - of results “distorts the published evidence base and is a threat to research integrity”, and is calling for the government to set up a national monitoring system and impose sanctions on those failing to report trial results.
An inquiry into research integrity in the UK has led the Committee to conclude that not enough has been done by the Health Research Authority (HRA) to improve reporting rates.
It says the HRA should produce a strategy for boost disclosure and that the group’s performance should be measured against progress.
“An astounding amount of information from clinical trials is going unreported,” said Committee chair Rt Hon Norman Lamb MP.
“The HRA 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.”
A trials tracker website set up by Dr Ben Goldacre and colleagues at the Evidence-Based Medicine Data Lab shows that “most pharma companies have good rates of reporting within a reasonable timeframe”, but that the picture is much more mixed for Universities and other sponsors, MPs said.
Public Health England has three overdue trials dating from 2010-2016 relating to meningitis vaccination, while many NHS Trusts have high numbers of unreported clinical trials according to the site: the Manchester University NHS Foundation Trust has 13 overdue trials, NHS Greater Glasgow and Clyde has 12 that are due to have reported, and both Newcastle upon Tyne Hospitals NHS Foundation Trust and Hull and East Yorkshire Hospitals NHS Trust have 11 outstanding trials.
“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,” Lamb said.
According to the Committee, the HRA should be provided with government funding to establish a national programme to audit 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 HRA should also introduce a system of sanctions to drive improvements in transparency, and the Government “should consult specifically on whether to provide the HRA with the statutory power to fine sponsors for non-compliance”.
“People take part in these trials in good faith, hoping to help inform doctors and decision makers on vital issues affecting many of us every day. Their efforts are betrayed if the results are not made available at the end,” Lamb stressed.
Commenting on the Committee’s report, transparency groups Transparency International Health Initiative and TranspariMED said parliament’s “recognition of the issue is warmly welcomed, as are its excellent recommendations for finally fixing the problem. However, it is concerning that similar recommendations already made by the Committee in 2013 were subsequently largely ignored.”
“Failure to publish trial results is not a victimless crime: both patients and taxpayers pay a steep price,” added Dr Till Bruckner, founder of TranspariMED.
“A few years ago, the NHS misspent £600 million on Tamiflu because the results of eight clinical trials had remained hidden. The government urgently needs to take action 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.”