October 30, 2018
Transparency groups endorse parliament’s call for government to ensure that all clinical trials report their results
30th October 2018, London – UK Parliamentarians’ call for government to set up a national monitoring system and impose sanctions on institutions that fail to report the results of clinical trials must not be ignored and should mark a turning point in opening the results of these trials, warn the Transparency International Health Initiative and TranspariMED.
A report published today by the Commons Science and Technology Committee says nearly half of clinical trials still fail to publish their results, presenting a “risk to human health”.
At the end of last year Transparency International and TranspariMED, with others, published a report arguing the lack of access to complete, unbiased and undistorted evidence of the benefits and risks of drugs, medical devices and treatments harms patients, prevents public health agencies from making informed decisions, wastes public funds, slows down medical progress, and exposes shareholders to substantial risks. The groups called on government to ensure that all clinical trials are registered and fully reported.
Parliament’s recognition of the issue is warmly welcomed, as are its excellent recommendations for finally fixing the problem. However, it is concerning that similar recommendations already made by the Committee in 2013 were subsequently largely ignored.
Sarah Steingrüber, Programme Manager Transparency International Health Initiative, said:
“Once again the UK Parliament has found serious failings in the lack of transparency in clinical research and this time those warnings cannot afford to be ignored. Transparency over clinical trials is vital to ensure patients are receiving appropriate care and the benefits and risks have been properly considered. The public must be able to trust the medical products they are taking are going to improve their health and likewise that public money is being used in the right way.”
Dr. Till Bruckner, founder of TranspariMED, said:
“Failure to publish trial results is not a victimless crime: both patients and taxpayers pay a steep price. A few years ago, the NHS misspent £600 million on Tamiflu because the results of eight clinical trials had remained hidden. The government urgently needs to take action to ensure that all trials involving UK patients are registered and fully reported. As parliament has pointed out, fixing this problem is not only possible, it is also far cheaper than continuing to ignore it.”
The 2017 report from Transparency International and TranspariMED called for:
- Trial registration: All clinical trials must be registered before they start.
- Summary results posting: Headline results must be made public within 12 months.
- Full trial reports: Detailed trial findings must be proactively disclosed.
- Academic publication: Trial results must be published in academic journals or made freely available in appropriate trials registries or databases (preferably both).
- Individual participant data sharing: Frameworks, standards, policy and legislation that enable effective, vigilant individual participant data sharing should be established.
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