UK parliament demands sanctions for clinical trial non-reporting

The chair of a key parliamentary committee has reiterated his demand for "a system of sanctions for those who do not comply with reporting results requirements for clinical trials".

The statement by Norman Lamb MP, Chair of the Science and Technology Committee, comes in response to an open letter by a coalition of twelve patient and integrity groups asking him to help put an end to impunity in medical research.

Norman Lamb MP said:

“The Health Research Authority (HRA) must follow my Committee’s recommendation from last Autumn 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.

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.”

Transparency campaigners are concerned that behind the scenes, the Health Research Authority may be trying to push back against sanctions.

• First, the HRA refused to release information on its legal powers to impose sanctions, thereby precluding informed public debate.

• Then, according to meeting minutes released by the HRA, an advisory group it set up "felt" that “discussing firmer [sic] sanctions was premature”. The AllTrials campaign, which had participated in the advisory group session in question, later made clear that it actually strongly supports sanctions.

• A consultation document issued by the HRA states that "In deciding whether to take these actions [sanctions], we need to consider not only what could be effective, but also what is reasonable. We would also only take actions once sponsors have had a reasonable opportunity to comply or to make a case for why they are unable to comply." It also states that before imposing sanctions, the HRA would perform yet another round of consultations.

Till Bruckner, founder of TranspariMED, said:

"If a patient participating in a trial parks on double yellow lines outside a university hospital, she has to pay a fine. But if the university then fails to make the results of the trial public, it does not face any sanctions, despite the fact that hidden medical evidence can and does cause considerable harm.

This impunity runs directly contrary to the interests of patients and the public. History has clearly shown that voluntary compliance alone does not work. It is excellent to hear that Norman Lamb will continue to forcefully advocate for patients' and taxpayers' interests."

In a Tweet, the Health Research Authority responded that: