Legislation to make trial data transparent could be threatened (Image: Christian Thomas/Getty)
A NEW front opens today in the ongoing struggle to improve transparency in medical research. The latest battleground is a legal challenge against a UK regulator by a company that runs clinical trials for pharmaceutical companies. Campaigners fear that victory in court could upend moves towards greater openness. It is important this does not happen.
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The argument for greater transparency is well known: the results of up to half of all clinical trials are never published. Positive results are around twice as likely to be published as negative ones, so the evidence on which doctors base decisions is skewed, potentially portraying treatments as more effective, and less risky, than they really are.
In January 2013 the campaign was launched to push for change, headed by the charity (SAS) and campaigning journalist Ben Goldacre. With supporters now including the UK鈥檚 Medical Research Council, the National Institute for Health and Care Excellence and over 500 other organisations, AllTrials was instrumental in putting transparency on the agenda during drafting of new European Union clinical trials regulations.
The outcome was that from 2016 all trials in Europe will have to be registered in publicly accessible databases, and their results reported within a year of wrapping up. It was deemed a major victory.
Judicial review
However, Richmond Pharmacology, which runs small, early-stage clinical trials, including 鈥渇irst in human鈥� studies, launched a judicial review in March, challenging the move towards greater transparency by the UK regulatory body for clinical trials, the Health Research Authority (HRA). At a late stage, Richmond asked the judge to rule that there was no general legal requirement for researchers to publicly register any clinical trial. This would contradict existing law and the new EU law that is due to come into force next year, says Sile Lane, campaign director for SAS. If the HRA lost, it could set progress on transparency in the UK back to a point before the AllTrials campaign began.
鈥淲e saw a serious risk that the public鈥檚 expectations of transparency, the hard won progress of two decades, and new advances in patient safety, would be unwittingly sacrificed in a squabble between a company and the regulator,鈥� says Tracey Brown, director of SAS.
That鈥檚 why SAS will act as the voice of AllTrials at today鈥檚 court hearing in Manchester via written arguments. It has tried to get the scope of Richmond鈥檚 legal arguments narrowed to technical points that would not threaten trial regulation, create loopholes that future trials could slip through or nullify the new EU regulations.
It is hopeful that this will happen because Richmond has already narrowed its arguments 鈥� but it has also switched arguments four times already, 鈥渟o we cannot make any assumptions,鈥� says Brown. Richmond said that it could not comment because the case is still ongoing.
鈥淎 victory will be if the hearing is dull as hell,鈥� Brown says. Let鈥檚 hope it鈥檚 a dull day in court then.
Simon Makin is a science writer based in the UK. His blog is
