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Half of EU clinical trials have flouted rules on reporting results

Commercially sponsored trials much more likely to post results than trials with non-commercial sponsors

Louise Prime

Friday, 14 September 2018

Just over half of clinical trials on the European Union (EU) register have not posted their results even though regulations say they should all post within 12 months of completion, research has revealed. The study*, published in the BMJ, found that although compliance with the EU rules has been poor overall, compliance among pharmaceutical companies has been good and universities have performed much more poorly.

The researchers, led by Dr Ben Goldacre at the University of Oxford, said previous cohort studies have shown that clinical trials results often go unreported; and US legislation from 2007, intended to fix this problem, has been widely ignored. And although recent EU rules require all trials conducted in Europe on medicinal products to report results directly on to the EU Clinical Trials Register (EUCTR) within 12 months of trial completion, compliance with these has never been assessed. So, they conducted a retrospective cohort study to ascertain compliance rates with these regulations (final compliance date 21 December 2016); to identify features associated with non-compliance; and to rank sponsors by compliance. They also built a tool for live ongoing audit of compliance.

They reported that of 7,274 trials where results were due, just 49.5% reported results. Trials with a commercial sponsor were substantially (and significantly) more likely to post results than those with a non-commercial sponsor (68.1% vs. 11.0%, adjusted odds ratio 23.2); as were trials by a sponsor who conducted a large number of trials (77.9% vs. 18.4%, adjusted odds ratio 18.4). More recent trials were also significantly more likely to have reported their results (per year odds ratio 1.05). The researchers added: “Extensive evidence was found of errors, omissions, and contradictory entries in EUCTR data that prevented ascertainment of compliance for some trials.”

They concluded: “Compliance with the European Commission requirement for all trials to post results on to the EUCTR within 12 months of completion has been poor, with half of all trials non-compliant. EU registry data commonly contain inconsistencies that might prevent even regulators assessing compliance. Accessible and timely information on the compliance status of each individual trial and sponsor may help to improve reporting rates.”

The team have developed a live online searchable web resource that shows the reporting status of every individual trial conducted in Europe and overall performance rankings for every sponsor, and these openly accessible data are updated every month so that the site will quickly reflect any improvement in reporting performance by trials sponsors.

They said: “We hope that the accessible and timely information on the compliance status of each individual trial and sponsor provided by our EU.trialstracker.net will help to improve reporting rates.”

*Goldacre B, DeVito NJ, Heneghan C, et al. Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource. BMJ 2018; 362: k3218 doi: 10.1136/bmj.k3218.

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