MPs propose fines for universities that fail to report trials

Universities that fail to publish the results of clinical trials that they have sponsored should face sanctions, potentially including fines or the refusal of approval for future experiments, according to MPs.

Under European Union rules, sponsors of clinical trials conducted within the bloc are expected to report their results on a continent-wide register within a year of completion. But MPs on the UK’s House of Commons Science and Technology Committee have expressed concern about research published earlier this year, which found that only about half of all European trials – and just 11 per cent of those run by universities – complied with the rules.

In a report published on 30 October, the panel highlights that enforcement of the EU’s clinical trials transparency rules is not expected to begin until next year, after the UK leaves the bloc, meaning that they will not be incorporated into British law. The MPs recommend that the UK government should “explicitly commit” to introducing the same transparency requirements.

They also raise concerns about the effectiveness of the UK’s Health Research Authority, which oversees the research ethics committees that give approval to all accredited clinical trials. The MPs say that the authority “appears to be reluctant to enforce its rules, or to make previous compliance with transparency legislation a pre-requisite for ethical approval of future trials”, highlighting that no sanctions have been imposed on sponsors or researchers who fail to comply with reporting regulations.

Giving evidence to the committee, Jonathan Montgomery, chair of the HRA, said that basing approval of new trials on the reporting of previous experiments would be “tricky”. But the MPs take a different view.

“We 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 committee’s report says. “The government should consult specifically on whether to provide the HRA with the statutory power to fine sponsors for non-compliance.”

The MPs also recommend that ministers 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”.

In its evidence, the HRA expressed concern about the cost of conducting a national audit of clinical trials transparency, so the MPs recommend that the agency should be provided funding for this exercise, “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 committee says the estimated cost of this – around £2.4 million annually – would be a “small price to pay” compared to the cost of needless research or poor procurement resulting from misreporting.

Norman Lamb, the committee’s chair, said that 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 taxpayer has a right to expect those who benefit from public funding to follow the rules and publish in full,” Mr Lamb said.

Teresa Allen, chief executive of the HRA, said that the organisation was “committed to do more to drive research transparency”.

“Transparency is essential so that participants are protected from unnecessary research and patients benefit from improved outcomes and care informed by high quality studies. We will act on the recommendations published by the select committee today, and report on our progress,” she said.

rachael.pells@timeshighereducation.com