More than 1,600 clinical trials run by UK universities violate reporting rules
UK universities have failed to post the results of 1,671 clinical trials onto trial registries, a report published today by TranspariMED and Universities Allies for Essential Medicines UK shows.
As a result, public health bodies, doctors and patients lack access to the full evidence base on drugs, medical devices and treatments currently being provided by the NHS, at the expense of patients and taxpayers alike.
Around 800 of these trials, many of them funded with public money, are in danger of becoming research waste. Unless universities post the results of these trials soon, valuable medical research data will be irretrievably lost.
Some universities, led by King’s College London, Nottingham and Cardiff, have recently made remarkable progress, posting many of their missing trial results.
However, 19 out of 27 universities have failed to upload a single missing trial result over the past two months. The report released today includes links to useful resources and a data set to help universities to identify and post overdue trial results.
The strongest performers on the European registry are Aberdeen (100% of trials reported) and King’s College London (96%), followed by Oxford, Dundee, and University College London.
Across universities, 62% of due trials listed on the European registry now have results; 38% are still missing results.
No UK university has yet achieved a strong reporting performance on the American registry. 97% of due trials listed on the American registry still have no results.
Out of the 1,671 clinical trials that are still missing results overall, 1,575 are listed on the American registry.
From a scientific and public health point of view, these trials are just as important as those on the European registry. For example, as the European registry only includes drug trials, all UK trials of medical devices in our study population are listed on the American registry.
In 2018, the Science and Technology Committee of the House of Commons called on the government to ensure that all clinical trials conducted in the UK fully report their results.
Responding to today's report, Committee chair Norman Lamb MP told the Daily Telegraph that:
““Our committee will be returning to this issue in the summer with a follow-up evidence session, so I’m putting all universities and NHS trusts on notice that they will be asked to come before us to explain themselves if they haven’t got their house in order by then.”
The data presented in this report strongly supports the Committee’s conclusion that a national clinical trial audit programme coupled with effective sanctions is indispensable to ensure consistent and timely reporting of medical research results across all trial registries by universities, NHS Trusts, and pharmaceutical companies.
In addition, universities and NHS Trusts require more official guidance and support for their trial registry clean-up efforts.
The government is expected to publish a formal response to the Committee’s recommendations in February 2019.
Lesley Stephen, a breast cancer patient from Edinburgh, said:
"We need to know that the results of all trials are being fully reported to learn honest lessons about what works and what doesn't. We need to have all the evidence at our disposal when we put a new pill into our bodies.
The government must take urgent action to deliver the transparency our health relies upon.”
Jackie Pullen, Director of King's Health Partners Clinical Trials Office, said:
“King’s College London is committed to assisting our researchers to widely disseminate the outputs of their research and ensuring clinical trial results are publicly available.”
Dr David Bembo, Director, Research & Innovation Services, Cardiff University, said:
“Cardiff University is committed to the Open Science agenda, recognising that in order to realise the full value of clinical trial research we need to make arising data accessible to the wider community. We are therefore taking steps to improve our performance in this area and will progress towards reporting results for all closed trials.”
A University of Nottingham spokesperson said:
“As an institution with a reputation for excellence in clinical research and application, the University of Nottingham recognises the importance of reporting clinical trials promptly and accurately. The registry environment can be complex, so we have published new staff guidelines to ensure our high quality academic practice is matched by high quality reporting. We are pleased with our recent rapid progress, aiming to complete any outstanding reporting shortly, and will maintain this going forward.”
Sarai Keestra, National Coordinator of Universities for Essential Medicines UK, said:
"Neglecting to post clinical trial results on an open-access registry is a waste of research effort and public funds, slows down medical innovation, and potentially endangers patients. UK universities owe it to doctors, patients and trial participants alike that the full results of these trials are freely accessible, so patients can receive optimal, evidence based treatments.
In short, publicly funded research should be made publicly available."
Dr Till Bruckner, Founder of TranspariMED, said:
“Many UK universities are still failing to tackle research waste, and the results of hundreds of clinical trials are in danger of being lost forever. This is deeply unethical, harms patients, wastes public money, and in some cases violates existing laws and regulations. Some universities have begun addressing the problem, but others are still sticking their heads into the sand.
The government must heed Parliament’s advice and set up a national monitoring system to ensure that all trials report their results, and fine pharmaceutical companies and universities that continue to break the rules. This common-sense solution would enable the NHS to save millions and improve patient care.”
Professor Susan Bewley, Chair of HealthWatch, said:
"Good medical practice depends on good science and integrity. Progress is made by the ‘many eyes’ of science, but that requires all data of all studies to be reported. We look forward to seeing that compliance with reporting rules is monitored and improves further.”
Over the coming months and years, TranspariMED and UAEM will continue to document the sector’s progress by regularly publishing follow-on progress reports.
TranspariMED is a global initiative based in Bristol that works to end evidence distortion in medicine.
UAEM is a global network of university students who work to improve access to public health goods.