European universities failing to report clinical trial results

Thirty-two academic institutions have so far failed to report any of their trial data in accordance with new European Union rules

September 14, 2018
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Results of the vast majority of clinical trials conducted by universities are not being reported as required under European Union rules, a study has found.

Since the end of 2016, sponsors of all clinical trials conducted within the bloc have been required to report their results on the European Union Clinical Trials Register within a year of completion.

Ahead of the implementation next year of regulations backing up the requirements with the threat of fines, a study published in the BMJ reveals that, of 7,274 registered trials that were examined, almost half (49 per cent) have failed to comply with the reporting rules.

Academic researchers were shown in a particularly negative light, with just 11 per cent of trials run by universities, along with hospitals, governments and charities, reporting their results correctly, compared with 68 per cent of commercial trials.

Ben Goldacre, director of the DataLab at the University of Oxford and lead author on the paper, said that failing to report results “strikes 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,” Dr Goldacre said.

“We hope that our data will help trial sponsors to move fast and get their houses in order. We have identified the individual non-compliant sponsors, and trials, in order to help them do so.”

The best academic performer was the University of Dundee, which had reported the results of 82 per cent of trials on the database. Some 32 major universities have so far failed to share the results of any of their registered trials, however.

These include Sweden’s Karolinska Institute, Belgium’s Ghent University, and several German institutions, such as Charité - Universitätsmedizin Berlin and LMU Munich.

The BMJ study stresses that not only had compliance with the ruling been “poor”, but the existing EU registry data contained so many “inconsistencies” that regulators were finding it difficult to assess the full extent of reporting.

According to the paper, universities were “more likely to be unaware of their obligations or lack administrative procedures to flag breaches and support compliance among their researchers. They may also lack clear lines of responsibility.”

Norman Lamb, chair of the UK's House of Commons Science and Technology Committee, described the “variation in compliance rates from university to university” as “very troubling”.

“Failing to report results from clinical trials distorts the evidence base,” he said. “Non-publication of results means that time and public money invested in the research is wasted, and risks crucial health-related decisions being made without access to all the facts.

“Some universities are taking this seriously and are clearly checking to make sure that the trials they are involved with publish results, but far too many have a poor record by this measure.”

rachael.pells@timeshighereducation.com

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