How to get all UK clinical trials registered and reported
Britain’s parliamentary Science and Technology Committee is currently conducting an enquiry into research integrity. At the end of the enquiry, the committee will issue a report setting out recommendations for the government.
This presents a unique opportunity to take a huge step towards solving the well-documented problem of reporting bias, evidence distortion and research waste caused by the currently widespread non-reporting and misreporting of clinical trials conducted in the UK.
As the British Medical Association has explained:
“Doctors need accurate and unbiased information on the efficacy and safety of different treatments to help them prescribe properly, safely and most effectively for their patients. If data from clinical trials are withheld or otherwise not available, doctors cannot be sure of the risks and benefits of using particular drugs thus risking avoidable harm to patients and wasting scarce NHS resources.”
In a formal submission of evidence to the committee, HealthWatch UK, Universities Allied for Essential Medicines UK, and TranspariMED together with Dr Simon Kolstoe have proposed setting up a National Clinical Trials Audit System.
Under the proposal, the Health Research Authority (HRA) would use existing records to track whether clinical trials are pre-registered, post their summary results onto trial registries, and report outcomes in medical journals.
The feasibility of the proposed audit system has been proven in a pilot project, and it would deliver huge savings to the NHS at little cost while improving health care provision and patient safety. Importantly, it would impose no additional red tape on medical researchers conducting trials in the UK.
The AllTrials campaign, representing 734 health groups, and Dr Ben Goldacre, the author of the bestselling book Bad Pharma, have separately also called for a national audit system to be set up.
The general principle of registering and fully reporting the results of all clinical trials has strong support within the UK medical community. It has been endorsed by leading groups including:
Health Research Authority (HRA)
National Institute for Health and Care Excellence (NICE)
Association of Medical Research Charities (AMRC)
National Institute of Health Research (NIHR)
Medical Research Council (MRC)
Department for International Development (DfID)
Cancer Research UK
We strongly hope that in the coming weeks, the House of Commons SciTech Committee will invite us to give oral evidence and explain the benefits of the proposed system.
If your organisation would like to formally support our proposal, please get in touch. This is a golden opportunity to make a real difference. Please add your voice now so that in future, doctors and patients will be able to access all available evidence on the benefits of drugs, devices and medical treatments.
For more information, please see this two-page policy brief and our joint submission to the House of Commons SciTech Committee.