Half of EU clinical trials not complying with guidelines, study finds
Half of all clinical trials on the EU Clinical Trials Register (EUCTR) do not comply with the European Commission’s requirement that all trials post results to the registry within 12 months of completion, a retrospective cohort study has found.
Researchers looked at 7,274 trials which were listed as completed on the EUCTR and where results could be established as due. Of these, they found that just 49.5% (3,601) had reported their results as required.
They also discovered that trials with a commercial sponsor were more likely to post results than those with a non-commercial sponsor (68.1% versus 11.0%). Trials conducted by sponsors with a large number of trials on the register also had a higher proportion of results reported, as did more recent trials.
The researchers also found extensive evidence of omissions and contradictory data in the EUCTR. Just under 30% of trials marked as completed gave no completion date, which prevents ascertainment of compliance with reporting requirements. There was also evidence that completed trials were mislabelled as ‘ongoing’ in some countries.
“Compliance with the European Commission guideline, which aims to ensure that all trials report results within 12 months of completion, has been poor,” the authors concluded.
“We hope that accessible and timely information on the compliance status of each individual trial and sponsor will help to improve reporting rates.”
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205448
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