EU universities are miserably lax at reporting clinical trial results, analysis suggests
The value of publishing clinical trial data cannot be exaggerated — it is crucial to the pace and direction of scientific progress, and critical to the knowledge base employed by patients, doctors and policymakers to make decisions about the safety, benefits and adoption of treatment interventions. But not everybody is quite as concerned with the toll clinical trial transparency transgressions can take on patient health, public health policy and medical advancement — a new report suggests European Universities are extraordinarily guilty of these reporting violations.
The report, published on Tuesday, evaluated the performance of 30 European universities that have sponsored the largest number of clinical trials governed by the European Union. Since 2014, the EU has mandated every study registered on the EU clinical trials registry post summary results onto the registry within one year of completion (6 months for pediatric trials) — these rules also apply to trials completed prior to 2014, and must be adhered to irrespective of whether results have been published in academic journals.
Altogether the evaluated universities have sponsored 4,575 clinical trials, of which results are verifiably due for 940 trials. But only the results of 162 (17%) trials have been posted on the EU Clinical Trials Register, the report found. Data for the study was collated and analysed by a consortium of European institutions: UK’s TranspariMED, Germany’s BUKO Pharma-Kampagne, Belgium’s Test Aankoop and Netherland’s Health Action International (HAI).
“Failure to fully and rapidly report clinical trial results is not a victimless crime…Some (UK) universities have already posted over 90% of their trial results, showing that where there is a will, there is a way. Why are universities that break the rules still receiving public funds to run additional trials?” Till Bruckner, founder of TranspariMED said in a statement. Truckner co-authored a report in 2017 that analysed six drug case studies — including Vioxx and Tamiflu — in which trial opacity directly harmed patients, taxpayers and/or investors.
In the current analysis, most of the 778 clinical trials verifiably missing results were run by universities in Denmark (246 trials), Austria (225), and Germany (117) and none of the assessed universities in France, Italy, Norway and Sweden have made a single clinical trial result public on the registry, the report found.
Data extracted from the EU Clinical Trials Register via the EU Trials Tracker. Accurate as of 01 April 2019.
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These numbers above may not even reflect the actual state of affairs, given that many trials listed as “ongoing” on the European trial registry were in fact completed long ago, researchers underscored. As it stands, EU universities are empowered to upload their summary results onto the EU registry as trial sponsors, but they cannot directly update the status (ongoing/completed) of the trials. Instead, universities are supposed to notify their national medicines regulator when a trial is completed, and the regulator is then meant to revise the trial’s status on the registry. “For example, universities in the Netherlands have run 967 trials in total, but only 23 of those (2.4%) are marked as “completed”. This number is completely implausible, as registry records show that many of those trials started over five years ago. (In the UK, where a registry update is ongoing, the proportion of “completed” trials in the cohort is 27.4%.),” the report noted.
A potential reason why EU researchers — who are not facing the same level of scrutiny as their UK counterparts — have not bothered with complying with their transparency obligations could be the lack of incentive, Test Aankoop’s Van Hecke Martine told Endpoints News. “The focus of researchers is publication of their study results in scientific journals, as this is rewarded in their professional evaluation and so it’s important for their career.”
The only bright spark in the report were UK universities — some of which have reporting rates of over 90%, largely due to enduring pressure from parliament, the public and research funding bodies. Outside of the UK, 730 out of 785 verifiably due trials (93%) are currently missing results, data indicated.
“There is no good reason why, if UK universities can do it, their counterparts across Europe can’t. This should be the stimulus others need to get their act together and meet their transparency obligations. The apparent contempt shown by many Universities must not be allowed to stand.” HAI senior policy advisor Ancel.la Santos told Endpoints News.
Once upon a time, UK universities were similarly lax about their reporting obligations. But concerted pressure has yielded impressive returns. For example, King’s College London enhanced its reporting rate from a woeful 18% to a respectable 93% within six months. The University of Nottingham — spotlighted by the UK parliament’s science and technology committee for its weak performance last year — has now posted the summary results of over 95% of its trials, the report noted.
But data compiled by Ben Goldacre, best-selling author, medical doctor and researcher who focuses on unpacking the misuse of science and statistics in his books Bad Science and Bad Pharma, out of his lab at the University of Oxford suggests that UK universities are less reliable than drug developers at fulfilling their clinical trial reporting obligations.
Across the Atlantic things aren’t much better. An analysis published last month by Universities Allied for Essential Medicines (UAEM) and non-profit research advocacy group TranspariMED showed that 40 leading US universities should have posted the results of 450 clinical trials — but over a third (31%) of those results are missing.