U.K. patient groups demand action on trial data nondisclosure as politicians ramp up pressure

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A parliamentary committee is looking to put more pressure on those who don't share their clinical data. (Avanti)

Patient groups in the U.K. are getting fed up with what they see as a pushback from the very organization set up to try to promote clinical trial transparency.

Last year, the British government asked the Health Research Authority (HRA) in the U.K. to “introduce a system of sanctions to drive improvements in clinical trials transparency, such as withdrawing favorable ethical opinion or preventing further trials from taking place,” with future thought being given to giving it stronger, statutory power to fine those who won’t comply.

But, according to a coalition of 12 patient and healthcare groups including the world-renowned Cochrane group, the HRA is dragging its heels. The signatories want the body to have a stronger resolve to fix the issue of trial data being deliberately withheld from the wider public and are pushing the government to do something about it.

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“Behind the scenes, the Health Research Authority appears to be pushing back against the imposition of sanctions,” according to a letter to Norman Lamb MP, chair of the House of Commons Science and Technology Committee, sent by the group last week.  

They argue that the HRA “refused to release information on its legal powers to impose sanctions” and that an advisory group convened by the HRA stated that “discussing firmer [sic] sanctions was premature”.

In its open letter, the group said: “We do not share the HRA Group’s perspective that discussing sanctions is ‘premature’. The HRA itself has held a mandate to promote transparency in health research since 2011, and reporting clinical trial results has been a global medical research ethics requirement since 2013.”

Till Bruckner, founder of TranspariMED, one of the signatories, said: “Without sanctions, a trial registration and reporting rate of 100% will remain unattainable. Presumably, a very large majority of trial participants, NHS patients and UK taxpayers would support sanctions, but their voices are not being heard. Only Parliament can effectively represent their views in this policy process. Parliament should remind the Health Research Authority of public expectations, to ensure that this problem gets fixed once and for all.”

Lamb, a known supporter of clinical trial transparency, responded this week, reminding the HRA that it “must follow” the committee’s recommendation from last fall to introduce a system of sanctions for those who do not comply with reporting results requirements for clinical trials.

“For too long there has been little consequence to non-compliance with current requirements and it’s time action was taken,” he wrote.  “I will be writing to the HRA to encourage them to propose a system of sanctions in their response to their consultation on the HRA’s draft transparency strategy, which closes next month.

“My committee is committed to ensuring improvements in clinical trials transparency and we will continue to push for change in this area. This year we have already written to NHS Trusts in England and universities across the UK reminding them of their responsibilities and put them on notice that if they didn’t get their houses in order, we would be asking them to come before us to explain themselves. We will be holding this follow-up session in the Autumn and will announce details in due course.”

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