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When it comes to reporting on the results of potentially life-changing medicine, almost 90pc of academic clinical trials in the EU never see the light of day. Why?
When we think back to the devastating Ebola outbreak that spread across West Africa between 2013 and 2016, killing more than 11,000 people, our memories might recall the imminent demand for a vaccine.
While at the time the obvious answer would have been to quickly develop and trial a potential vaccine for the sake of those attempting to survive a deadly disease, there is a reason why candidates are slow to arrive.
With any pharmaceutical medication, time and regulation are needed to ensure all safe practices are carried out and that any potential medication does exactly what it says, without serious side effects. It is then up to the researchers working on these drugs to be completely open and honest with the world as to what happened when a prototype went through rigorous testing.
However, a recent survey published by The BMJ has shown that despite being seen as a champion of bureaucracy where nothing escapes the red tape, the EU is something of a ‘Wild West’ when it comes to reporting clinical trial results. The findings showed that almost half (49pc) of trials registered in the EU have never reported results on their findings.
Vast majority goes unreported
But before you think that this is a problem with big pharma attempting to initiate a cover-up in order to push more medication, you should think again.
The real problem lies in academia, where only a staggering 11pc of the results of non-commercially sponsored trials ever make it to the online register, compared with a more respectable 68pc revealed by companies. In fact, the BMJ research found that 11 of the major pharmaceutical companies are totally transparent with their results, while the highest university in the UK to report results was the University of Dundee, with an 82pc report rate.
This situation continues six years after the European Medicines Agency (EMA) enacted regulation that required the results of a trial to be reported online no later than one year after it finished, or within six months if it involved children.
The lack of reporting is now so commonplace that the BMJ runs a weekly series documenting just some of the results that never got reported.
So, why are so many academics getting to flaunt the rules? According to the report’s authors, a portion of the blame has to be put on the EMA as it is legally required to flag any trials that don’t report on results. Yet so far, the authors believe that no trial sponsor has ever been contacted about their failure to post results.
“This problem strikes to the heart of evidence-based medicine,” said Dr Ben Goldacre, lead author of the research, and director of the DataLab at the University of Oxford. “We cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported.”
No excuses
One of those particularly vocal about this topic is Síle Lane, head of international campaigns and policy at Sense about Science, an organisation based in Ireland and the UK that challenges the misrepresentation of science and evidence in public life.
“There’s no excuse for failing to report results,” she said. “Why should these institutions be allowed run any more trials on patients? Why are ethics committees giving them permission to run more trials? Why are funders paying for them?”
At the time of writing, I’m awaiting a response from the EMA about the claim that it has failed to report these hidden trial results, but the study’s authors claim that excuses such as a researcher moving to a different institution, or that decade-old trials aren’t relevant any more, are not valid.
Universities ‘must get their house in order now’
Meanwhile, across the Atlantic Ocean, the US Food and Drug Administration (FDA) has an altogether different attitude. Last week, it proposed enacting heavy fines for pharma companies that fail to report clinical trial results online. The draft document seen by Nature showed that the US government is considering fining offenders $10,000 each day they fail to upload the results.
Research conducted into the US’s attitude to posting results showed an arguably worse response than the EU, with 58pc of industry trials and 61pc of non-commercial trials there failing to post results.
Another recent US study done on the topic in Psychological Medicine found that four types of bias – ranging from a fear of posting negative results to outright spin – led to results not being posted or remaining hidden. The last one is particularly damaging as evidence showed that an inconsequential result can sometimes be rewritten in such a way to convince a reader it is worthy of further investigation.
As for the EU, the hopes of advocates for greater oversight are pinned on the EU Clinical Trials Regulation, due to come into force next year. There is also the recently launched EU Trials Tracker tool, which lets the general public track which companies and universities are failing at their task of producing results, regardless of whether they are positive or not.
Speaking of the incoming legislation, Goldacre said: “It will bring substantial financial penalties for sponsors in breach of reporting requirements. All trial sponsors – especially universities – must get their house in order now.”
