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 reveals that, of 7,274 registered trials聽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.
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Ben Goldacre, director of the DataLab at the University of Oxford and lead author on the paper, said that failing to report results 鈥渟trikes to the heart of evidence-based medicine鈥.
鈥淲e cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported,鈥 Dr Goldacre said.
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鈥淲e 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.鈥
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鈥檚 Karolinska Institute, Belgium鈥檚 Ghent University, and several German institutions, such as Charit茅 - Universit盲tsmedizin Berlin and LMU Munich.
罢丑别听BMJ聽study stresses that not only had compliance with the ruling been 鈥減oor鈥, but the existing EU registry data contained so many 鈥渋nconsistencies鈥 that regulators were finding it difficult to assess the full extent of reporting.
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According to the paper, universities were 鈥渕ore 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.鈥
Norman Lamb, chair of the UK's House of Commons Science and Technology Committee, described the 鈥渧ariation in compliance rates from university to university鈥 as 鈥渧ery troubling鈥.
鈥淔ailing to report results from clinical trials distorts the evidence base,鈥 he said. 鈥淣on-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.
鈥淪ome 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.鈥
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