Patient groups demand sanctions on those who fail to report clinical trial results
A coalition of twelve patient and integrity groups today called on UK parliament to put its weight behind efforts to end impunity in medical research.
In an open letter, the coalition highlighted Parliament’s 2018 recommendation that:
“the HRA [Health Research Authority] 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.”
The groups called on Norman Lamb MP to write to the Health Research Authority “to remind it of Parliament’s expectations, and encourage it to set out a clear timetable for the phasing in of sanctions”.
Norman Lamb MP is the Chair of the House of Commons Science and Technology Committee.
Behind the scenes, the Health Research Authority appears to be pushing back against the imposition of sanctions:
First, the HRA refused to release information on its legal powers to impose sanctions, thereby precluding informed public debate.
Then, an advisory group convened by the HRA stated that “discussing firmer [sic] sanctions was premature”.
In its open letter, the coalition of patient and integrity groups noted that:
“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.”
The groups also point out that parliament had already recommended imposing sanctions in 2013. Back then, the HRA ignored that recommendation. Its efforts over the following years to promote compliance on a purely voluntary basis failed to adequately improve clinical trial registration and reporting, leading parliament to launch a second enquiry into the same issue five years later.
Today’s open letter is signed by twelve groups:
Action against Medical Accidents
International Alliance of Patients’ Organizations
Sling the Mesh
Transparency International Health Initiative
Universities Allied for Essential Medicines Europe
Universities Allied for Essential Medicines UK
The AllTrials campaign has also warned that sanctions including fines “will be necessary to ensure 100% compliance.”
Till Bruckner, founder of TranspariMED, 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.”
Norman Lamb MP is a noted supporter of clinical trial transparency. After he wrote to universities asking them to tackle the issue, many (but not all) institutions tightened their policies and significantly improved their performance, making the UK the European leader in clinical trial transparency in the space of just a few months.
Add your voice to the debate:
Make a submission to the HRA’s ongoing public consultation
Tweet your views to the HRA using the twin hashtags #MakeItPublic and #AllTrials
Click below to read the full open letter: