Clinical Trial Transparency at European Universities: Mapping unreported drug trials

peter.suber's bookmarks 2020-08-17

Summary:

"Failure to report clinical trial results is not a victimless crime. It has substantial negative consequences for patients and public health. Since July 2014, European Union rules have required each and every clinical trial registered on the EU clinical trials registry to post summary results onto the registry within 12 months of trial completion (6 months for paediatric trials). These rules also apply to trials completed before 2014, and apply irrespective of whether a trial’s outcomes have been published in the academic literature. Thus, all of the clinical trials identified in this report as missing summary results are in violation of European Union transparency rules that were designed to protect the interests of patients and taxpayers. Key findings Overall, 778 clinical trials run by 30 European universities (83% of due trials) are verifiably missing results on the European trial registry, in violation of EU transparency rules. Excluding UK universities, reporting rates are just 7%. The actual figure of due trials missing results is likely to be far higher.  Only three universities perform well: University of Oxford, University College London, and King’s College London. These universities have already posted over 80% of their trial results.  Fourteen universities have failed to post a single clinical trial result. This includes all assessed universities in France, Italy, Norway and Sweden.  The remaining 13 universities also perform weakly, with reporting rates ranging from 2-33%. The fact that UK universities outperform their European peers by a wide margin is due to a combination of pressure from parliament, research funders, and the public. The strong performance by front-runner universities in the UK demonstrates that universities elsewhere in Europe can – and can be expected to – do far better...."

Link:

https://docs.wixstatic.com/ugd/01f35d_42e869002189401d80a672d4ecff3f73.pdf

Updated:

08/17/2020, 10:43

From feeds:

Open Access Tracking Project (OATP) » peter.suber's bookmarks

Tags:

oa.medicine oa.clinical_trials oa.harm oa.patients oa.taxpayers oa.recommendations oa.uk oa.europe oa.pharma oa.lay

Date tagged:

08/17/2020, 14:43

Date published:

04/30/2019, 10:43