During its inquiry into research integrity earlier this year, the Committee agreed to follow-up on work on ‘clinical trials transparency’ by its predecessor Committee in 2013.
The Research integrity: clinical trials transparency Report highlights the work previously done by campaigners, which shows that a shocking 50% of clinical trials do not publish any results, presenting risks to human health and increasing research wastage.
The Committee is concerned that selective non-publication—‘or publication bias'—of results distorts the published evidence base and is a threat to research integrity.
The Health Research Authority (HRA) has been responsible for ‘promoting research transparency’ since 2014, but the Committee concluded that not enough had been done to improve reporting rates. The Committee wants the HRA to produce a strategy for fixing this problem and believes its performance should be measured against progress.
Witnesses pointed to explicit examples of ‘publication bias’ leading to wasted public expenditure in the UK and even patient deaths in other countries. The examples included the Government’s decision to stockpile millions of pounds’ worth of Tamiflu in response to the H1N1 'Swine Flu' epidemic in 2009, when the Committee heard that the Government was "relying on a marketing spiel claiming successful trials of this drug rather than being able to consider the actual evidence of the drug efficacy for themselves".
A trials tracker website set up by Dr Ben Goldacre and colleagues at the Evidence-Based Medicine Data Lab also reveals that Public Health England has three overdue trials dating from 2010–2016 relating to meningitis vaccination.
Meanwhile, 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.
Rt Hon Norman Lamb MP, Chair of the Science and Technology Committee, said:
“An astounding amount of information from clinical trials is going unreported. 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.
“It is particularly disappointing that trusted bodies such as Public Health England and a range of NHS Foundation Trusts are failing to report results from clinical trials. Public trust in medicine could easily be eroded by these failings from such important parts of the health system.
“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.
“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. We would urge the HRA to prioritise this issue and are disappointed with progress in tackling the issue over the past four years.”
The Committee also recommends that:
- The Government should 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. The performance of the HRA should then be explicitly measured on this basis through its annual report.
- The HRA should be provided with 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 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, and the Government should consult specifically on whether to provide the HRA with the statutory power to fine sponsors for non-compliance.