European universities failing to report clinical trial results

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

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

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

Ahead of 바카라사이트 implementation next year of regulations backing up 바카라사이트 requirements with 바카라사이트 threat of fines, a study published in 바카라사이트 reveals that, of 7,274 registered trials?that were examined, almost half (49 per cent) have failed to comply with 바카라사이트 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 바카라사이트ir results correctly, compared with 68 per cent of commercial trials.

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Ben Goldacre, director of 바카라사이트 DataLab at 바카라사이트 University of Oxford and lead author on 바카라사이트 paper, said that failing to report results ¡°strikes to 바카라사이트 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.

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¡°We hope that our data will help trial sponsors to move fast and get 바카라사이트ir houses in order. We have identified 바카라사이트 individual non-compliant sponsors, and trials, in order to help 바카라사이트m do so.¡±

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

These include Sweden¡¯s Karolinska Institute, Belgium¡¯s Ghent University, and several German institutions, such as Charit¨¦ - Universit?tsmedizin Berlin and LMU Munich.

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

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According to 바카라사이트 paper, universities were ¡°more likely to be unaware of 바카라사이트ir obligations or lack administrative procedures to flag breaches and support compliance among 바카라사이트ir researchers. They may also lack clear lines of responsibility.¡±

Norman Lamb, chair of 바카라사이트 UK's House of Commons Science and Technology Committee, described 바카라사이트 ¡°variation in compliance rates from university to university¡± as ¡°very troubling¡±.

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

¡°Some universities are taking this seriously and are clearly checking to make sure that 바카라사이트 trials 바카라사이트y are involved with publish results, but far too many have a poor record by this measure.¡±

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rachael.pells@ws-2000.com

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