Half of Europe's clinical trials fail to report results despite EU rule

[September 13, 2018]  By Kate Kelland

LONDON (Reuters) - Almost half of all European-registered clinical trials - in which scientists test drug treatments, interventions or therapies in humans - have breached EU rules by failing to report results, according to an analysis published on Thursday.

The analysis also found that while most major pharmaceutical companies are coming close to complying with EU reporting rules for trials in people, most major academic institutes are not.

European Union guidelines say that funders of clinical trials must ensure all studies entered on the EU Clinical Trials Register since 2004 have posted results there within a year of concluding.

Advocates for transparency in science say enforcing the rule is necessary to ensure researchers do not bury results they consider unfavorable.

But in work published in the BMJ British medical journal, researchers at Britain's Oxford University found that around 90 percent of trials funded by non-commercial sponsors - such as universities, hospitals, governments and charities - and about 32 percent of trials sponsored by drug companies have not published results onto the register.

Among the worst records were held by Helsinki University in Finland, which the analysis found had not posted results for any of its 12 currently overdue trials, and Britain's University of Nottingham, which had reported results for just one out of 17 overdue trials on the register.

"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?" said Síle Lane, head of international campaigns and policy for the science transparency group Sense about Science.

Ben Goldacre, who co-led the research as director of the DataLab group at Oxford, said the group's findings strike "to the heart of evidence based medicine".

"We cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported," he said in a statement.

The research was published to coincide with the launch of a new tracking website that shows which clinical trials on the European register have reported results and which have not. It also shows overall reporting performance for individual companies, universities and charities that fund clinical trials.

The analysis found that among major funders of clinical trials across academia and industry, only 11 had reported for 100 percent of their due trials. These 11 are all companies, including Boehringer Ingelheim, Almirall SA, Gilead Sciences Inc, Roche's unit Genentech, and LEO Pharma.

By contrast, 32 major sponsors have not published results for any of their due trials on the register. All 32 are European hospitals, universities and research institutions. The researchers defined major sponsors as those with 50 or more trials on the EU Clinical Trial Register.

(Reporting by Kate Kelland; Editing by Peter Graff)

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