Compliance With Requirement to Report Results on EUCTR Is Poor
Half of trials on European Union Clinical Trials Register are non-compliant with requirements
TUESDAY, Sept. 18, 2018 (HealthDay News) -- Half of trials on the European Union Clinical Trials Register (EUCTR) are non-compliant with the European Commission's requirement that all trials post results to the registry within 12 month of completion, according to a study published online Sept. 13 in The BMJ.
Ben Goldacre, M.B.B.S., from the University of Oxford in the United Kingdom, and colleagues conducted a retrospective cohort study to ascertain compliance rates with the European Commission's requirement that all trials on the EUCTR post results to the registry within 12 months of completion. Data were included for 7,274 of 11,531 trials listed as completed on the EUCTR.
The researchers found that 49.5 percent of the 7,274 trials where results were due reported results. The likelihood of posting results was considerably greater for trials with a commercial sponsor than those with a non-commercial sponsor (68.1 versus 11.0 percent; adjusted odds ratio, 23.2), as well as for trials by a sponsor who conducted a large number of trials (77.9 versus 18.4 percent; adjusted odds ratio, 18.4). Results were more likely to be reported for more recent trials (per year odds ratio, 1.05). In the EUCTR data there was evidence of errors, omissions, and contradictory entries for some trials that prevented ascertainment of compliance.
"We have found strong evidence that the European Commission guideline, requiring all trials' results to be reported on EUCTR within 12 months of completion, is commonly being breached," the authors write.