Many clinical trials run by NHS Trusts are missing results. Here’s how to fix the problem.
HealthWatch, TranspariMED and the patient-led group JustTreatment have just asked NHS Improvement to ensure that all NHS Trusts fully report the results of the clinical trials they run.
We propose that NHS Improvement take two steps:
Publish a strategy for cleaning up registry entries
Conduct a central audit of all NHS Trust clinical trials
A report on clinical trial transparency published by the House of Commons Science and Technology Committee last month highlighted the failure of several NHS Trusts to follow European Union guidelines and global best practices in trial reporting.
Such failures to report clinical trials are not a victimless crime. They harm patients, lead to the misallocation of public health resources, and slow down the development of new drugs, vaccines, medical devices and treatments.
For example, six Trusts located in Greater Manchester alone have between them failed to post the summary results of at least 62 clinical trials onto the main European and American trial registries.
Trials sponsored by Manchester University NHS Foundation Trust that are missing results include trials that recruited, or set out to recruit, the following patients:
Thirty autistic children aged 5-8 years
Fifteen infants and children with hyperinsulism
Sixty pregnant women with diabetes
One hundred and fifty patients who had suffered from heart attacks
One hundred and four people with severe asthma
To its credit, Manchester University NHS Foundation Trust has already begun uploading results that are missing from the European trial registry. (Whether it is also uploading missing results onto other registries is unclear.)
However, we do not know whether other NHS Trusts are also addressing the issue. Furthermore, with over 100 NHS Trusts spread across the country, fragmented efforts by individual Trusts are likely to yield only partial results.
We suggest that NHS Improvement take on this role because of its unique mandate of “overseeing foundation trusts and NHS trusts”.
A centrally conducted audit using a standardised methodology and data entry tool would be far more efficient, effective and cost-effective than isolated audit efforts by individual NHS Trusts, each of which would have to independently create its own audit frameworks and tools.
A centralised audit would provide reassurance to UK parliament, patients and taxpayers that the issue is being adequately and comprehensively addressed. We believe that such an audit could be completed based on public registry entries alone (i.e. without input from individual Trusts), by one person within just 1-2 months.
The subsequent cleaning up of registry entries would take considerably more effort. Fortunately, several UK institutions have already gained experience in cleaning up their existing trial registry entries, generating useful models that NHS Improvement can draw on.
For more details on how the proposed NHS Improvement audit and registry cleanup would work in practice, please see our policy paper:
TranspariMED will share NHS Improvement’s response to our proposal on this blog.