{"id":1832,"date":"2018-11-02T12:52:06","date_gmt":"2018-11-02T12:52:06","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmjebmspotlight\/?p=1832"},"modified":"2019-02-19T09:48:19","modified_gmt":"2019-02-19T09:48:19","slug":"clinical-trials-transparency-is-failing-heres-why","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmjebmspotlight\/2018\/11\/02\/clinical-trials-transparency-is-failing-heres-why\/","title":{"rendered":"Clinical Trials transparency is failing – here\u2019s why"},"content":{"rendered":"

 <\/p>\n

‘the current system is failing, and awareness isn\u2019t\u00a0 \u2018variable\u2019, it is wholly inappropriate and unethical.’<\/em><\/p>\n

Carl Heneghan<\/p>\n

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The UK\u2019s House of Commons Science and Technology Committee released its report on clinical trials transparency<\/a> last week and it makes for a sorry read.<\/p>\n

Clinical trials transparency means ensuring clinical trials are recorded in a publicly-accessible registry, summary results are published within a set time upon trial completion (usually 12 months) and results are reported in full.<\/p>\n

UK and EU rules and guidelines aim to ensure these three pillars of transparency are upheld. Yet, about half of clinical trials are still unreported. The Sci-Tech Committee is not impressed:<\/p>\n

\u2018many of the clinical trials taking place in the UK remain unregistered and unpublished and their data continue to be unavailable to both the general public and the scientific community. This is unacceptable and we have not been impressed by the Government\u2019s efforts to resolve this important issue.\u2019<\/em><\/p>\n

Of the three pillars of transparency I thought trial registration was largely sorted. I was wrong.<\/p>\n

\u2018In 2013, the Health Research Authority (HRA) made it a condition of a trial receiving a \u2018favourable opinion\u2019 from a research ethics committee that the trial must be registered\u2014or a deferral for specific reasons requested\u2014before participants are recruited.\u2019<\/em><\/p>\n

\u2018The HRA subsequently conducted several audits of registration, with follow-up contact with lead investigators where non-compliance was found. These demonstrated that registration was still not universal, even among trials that had received a favourable opinion, and that some who fell short on their compliance ignored contact from the HRA. The HRA\u2019s 2017 audit revealed that 32% of 599 studies that received a \u2018favourable opinion\u2019 (and no agreed deferral) could not be found on a publicly accessible registry. <\/em><\/p>\n

If I have this right, registration is a precondition of a favourable ethical approval; but this isn’t happening in a third of cases.\u00a0 The HRA concluded that \u201cawareness that the requirement to register a clinical trial as a condition of favourable opinion was variable.\u2018<\/p>\n

My conclusion, is the current system is failing, and awareness isn\u2019t\u00a0 \u2018variable\u2019, it is wholly inappropriate and unethical.<\/p>\n

Since 2014 the European Commision has required that all trials in the EU clinical trials register have to post results within 12 months. Here are today\u2019s results from the eu.trialstracker.net\/<\/a><\/u>\u00a0 –\u00a0 only 51.4% of trials sponsors have reported – I\u2019d, yet again, call that failing.<\/p>\n

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What’s also interesting is who is reporting results?\u00a0\u00a0 If you order the EU Trials Tracker<\/a> by percentage reported, the industry is at the top.\u00a0If you look near the bottom, universities are largely failing in their legal requirements.\u00a0 In The UK, for example, the University of Nottingham complies with its requirements for only 17 of 58 trials (5.9%).<\/p>\n

\"\"<\/a><\/p>\n

If you work at this university – or one of the others on the list – you may want to point these failings out. And if you work in the NHS or Public Health England you may also want to point out \u2018It is particularly disappointing that trusted bodies such as Public Health England and a range of NHS Foundation Trusts are also failing to report results from clinical trials.\u2019<\/em><\/p>\n

Wherever you look trials transparency is failing.\u00a0\u2018Our predecessor Committee concluded in 2013 that it had \u201cnot been impressed\u201d by the Government\u2019s efforts to resolve the problem of un-registered, non-reported and mis-reported clinical trials. We believe that while there have been some improvements there is still much more to be done.\u2019<\/em><\/p>\n

THE Sci-tech Committee has therefore tasked the UK\u2019s Health Research Authority to\u00a0 \u2018introduce a system of sanctions to drive improvements in clinical trials transparency, such as withdrawing favourable ethical opinion or preventing further trials from taking place, and the Government should consult specifically on whether to provide the HRA with the statutory power to fine sponsors for non-compliance.\u2019<\/p>\n

The question is, therefore, by 2022 –\u00a0 when we\u2019ll likely revisit these issues –\u00a0 will trials transparency still be failing?<\/p>\n

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References<\/p>\n