UK universities have failed to post the results of 1,639 clinical trials onto registries, a report published today shows. Only 9% of completed trials have posted results. The remaining 91% of trials are in breach of World Health Organization standards.
MIXED PERFORMANCE ON THE EUROPEAN TRIAL REGISTRY
The report documents strong differences in the performance of individual universities on the European trial registry. The strongest performers there are Aberdeen (100%), Dundee (82%), and Oxford (81%). UCL, Leeds and King’s College occupy the middle ground. The weakest major trial sponsor is the University of Nottingham, which has posted just 6% of its trial results.
DISAPPOINTING PERFORMANCE ON THE AMERICAN TRIAL REGISTRY
Data from the world’s largest trial registry, the American Clinicaltrials.gov, shows that UK universities’ performance in posting results onto there is significantly worse. Many of these trials are in danger of becoming research waste unless their results are posted soon.
THE INSIDE STORY: SOME UNIVERSITIES ARE ALREADY DOING THE RIGHT THING
The overall disappointing current performance of the sector as a whole hides strong momentum towards greater transparency by some leading universities. At least six universities are currently strengthening their policies and/or retrospectively posting missing trial results:
The results of such efforts typically take many months to yield publicly visible results. For example, Cardiff University launched a systematic drive to tackle its unreported trials earlier this year:
However, as of now, eight of the ten Cardiff-sponsored trials on the European registry are still missing results, as are all 17 of its trials on the American registry. Cardiff’s actual reporting record seems likely to significantly improve over the coming year.
WHY NARROW LEGAL COMPLIANCE IS NOT GOOD ENOUGH
There is a universal ethical obligation to report the results of each and every clinical trial. In addition, best practices set out by the World Health Organization require all trials to post their results onto registries within 12 months of completion, without exceptions.
The legal rules are more complicated:
A European Union guideline already requires all trials listed on the European trial registry to post their results within 12 months. This guideline will become a formal regulation in late 2019 or early 2020. Individual member states will be responsible for enforcing the regulation, but it is currently unclear which countries will do so in practice.
A U.S. law requiring trials to post their results within 12 months only applies to a minority of trials listed on the American registry. Other trials are not legally required to post their results there. U.S. authorities have recently taken tentative first steps towards beginning to enforce the law. Once they do so, UK universities could find themselves having to pay a $11,000 fine for every day that an applicable trial’s results are overdue.
Importantly, existing legal rules only apply to a minority of all clinical trials. For example, millions of patients’ lives and wellbeing depends on medical devices being effective and safe, as the ongoing controversy around vaginal mesh implants painfully illustrates. However, medical device trials currently cannot be registered on the European registry, and so fall outside the scope of the forthcoming EU regulation.
“We hope that this report will encourage universities and other stakeholders – government, parliament, the NHS, regulators, research funders, and ethics committees – to widen their focus and ambitions from narrow legal and regulatory compliance to meeting global best practices.”
HIGH TIME FOR DECISIVE GOVERNMENT ACTION
There is nothing to stop EU member states from imposing national reporting requirements that go beyond EU rules. However, policy makers have largely remained oblivious to huge amount of research waste and harm to patients caused by unreported clinical trials. Click on the image below to read one patient's personal story.
Only in the UK are politicians finally waking up. A parliamentary committee recently called on the government to create a comprehensive national transparency framework for clinical trials, including sanctions and fines for institutions that fail to report results. To a large extent, this policy blueprint is transferable to other countries.
Today’s report was jointly published by Universities Allied for Essential Medicines UK and TranspariMED to coincide with Global Access to Medicines Week.
CHALLENGING UNIVERSITIES WORLDWIDE TO DO BETTER
In the course of the coming week, UAEM student groups around the world - from Brazil to the U.S., from Austria to Denmark - will be challenging their universities to post their missing trial results.
Looking forward, UAEM UK and TranspariMED plan to regularly publish follow-on reports to keep up the pressure, give public recognition to universities that perform well, and document the sector’s progress over time.
The tools used to compile the data have been posted online and can be used by patient groups and transparency advocates in other countries to rapidly assess institutional performance and generate similar rankings to drive positive change.