UK parliament urged to sanction clinical trial violations

The UK should impose sanctions on pharma companies and research institutions that fail to make clinical trial results public, a parliamentary committee has been told.


In a joint submission, Cochrane, Transparency International Health and TranspariMED recommended that parliament should:


  1. Put into place sanctions with teeth for sponsors that fail to make trial results public, supported by a credible sanctions mechanism

  2. Publicly set a starting date for sanctions implementation

  3. Conduct annual follow-up sessions until the first sanction has been imposed


The groups pointed out that the UK’s drug regulator, MHRA, currently has no legal powers to sanction trial sponsors or compel them to make drug trial results public. They noted that the UK has made significant progress in clinical trial transparency in recent years – but cautioned that “global regulatory experience consistently shows that sponsors will not consistently make trial results public in a timely manner unless there is a threat of sanctions.”



The submission spells out in detail what an effective sanctions mechanism would look like.


It also contains a detailed discussion of legal and regulatory frameworks in the UK, European Union and United States, recent progress in trial reporting and remaining gaps, and global regulatory experiences with sanctions (see also here). It recommends that parliament should consider whether the MHRA could be given new powers to impose sanctions without requiring new legislation.


BROAD SUPPORT FOR SANCTIONS


Submissions by other groups and individuals also urged action on clinical trial transparency:


The student-led campaign group Universities Allied for Essential Medicines UK pointed to recent research on transparency gaps in global Covid trials and UK academic trials, UAEM-UK wrote that:


“We believe that universities have a responsibility to demonstrate best practice reporting because they are publicly funded institutions and should therefore work in the best interest of the public. This is especially pertinent because the untimely and inadequate reporting of trial results has a proven negative impact for UK patients, taxpayers, and investors… increasing the repercussions for not reporting will help to ensure that the detailed, timely and accurate reporting of clinical trials becomes the norm”


A group of academic researchers recommended that:


“Existing evidence shows that while many trials covered under these regulatory schemes share their results, gaps remain… The UK government should reinforce compliance with the #MakeItPublic campaign’s transparency policies by introducing sanctions, such as financial penalties, for companies, universities and NHS Trusts that do not make the results of their clinical trials public.”


The chair of the ISRCTN clinical trial registry, writing in a personal capacity, told the committee that:


“Campaigners such as AllTrials and Transparimed have become influential advocates of the public interest in transparency. Universities across the most research-active countries are finally responding to this pressure, and catching up with the levels of transparency that are now general practice in commercial health research.”


“[I]t is remarkable that medical charities for many years tolerated a high failure rate in research studies that affected their supporters, failing to chase up even studies funded by their own charitable efforts.”


“it is unclear how many research institutions recruit, reward and celebrate statisticians in proportion to their importance… [U]ntil recently it was commonplace for ethics committees to approve clinical research studies which later turned out to recruit too few participants to produce a statistically useful result.”


MAPPING OUT TRANSPARENCY OPTIONS


Other groups provided parliament with an overview of their clinical trial transparency safeguards, or proposed additional transparency measures:


  • The Health Research Authority provided an update on the progress of the national #MakeItPublic strategy

  • The Association of Medical Research Charities (AMRC) noted that the UK’s new national monitoring system “is being seen as a huge step towards clinical trial transparency”

  • The charity HealthWatch argued that “all trial protocols should be published in advance and reported. As well as aiding reproducibility, this would also greatly assist searching for unpublished trials (often negative) that might otherwise be ‘buried’ and distort the literature.”

  • The charity Sense about Science suggested investigating “the idea of funding bodies making transparency of data and methods a condition of securing future funding, to reduce the risk of unreliable results being used to make life-changing decisions without due scrutiny of their quality”

  • UKRI noted that the Medical Research Council, a major public research funder, runs regular reviews to check its grantees’ compliance with transparency requirements

  • Guy’s and St Thomas’ NHS Foundation Trust wrote that “We as a sponsor carry out periodic checks and permit access to sponsors from other trials to carry out checks for data validation and review”

  • The University of Edinburgh flagged its new initiative to improve research quality that “include[s] efforts directed at increasing the completeness of clinical trial reporting… and reducing the interval between completion and publication of research projects.”

  • Researcher Simon Kolstoe proposed that the committee “conduct a new inquiry looking specifically at Coronavirus research, and determining how much has been wasted”


PARLIAMENTARY ENQUIRY CONTINUES


All submissions listed above will feed into an ongoing enquiry into reproducibility and research integrity by UK parliament’s Science and Technology Committee.


While the committee does not have formal powers to sanction institutions or pass laws, it can have strong influence on government policy. The committee’s 2018 enquiry into clinical trial transparency directly led to the adoption of the UK’s widely acclaimed #MakeItPublic national clinical trial transparency strategy.



Note: The parliamentary enquiry’s remit also covers preclinical research and social science research. In total, the committee received 88 submissions of evidence, many of which did not discuss clinical trials. All submissions can be accessed here.


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