The Government said it had committed more than £120 million to boost access to clinical trials after an independent review found that the UK was falling behind the rest of the world in life sciences.
The review, chaired by former health minister Lord James O'Shaughnessy, proposed 27 recommendations for improvements across eight 'problem statements'. Recommendations included actions to be taken now and other longer-term strategies.
Lord O'Shaughnessy had been asked by the Government in February to report on how to resolve key challenges in conducting commercial clinical trials in the UK and transform the nation's commercial clinical trial environment. Since then, he had consulted with industry and a wide range of stakeholders across the UK clinical trials sector.
UK Lagging in Clinical Trials
The report found that the UK's response to the COVID-19 pandemic, through vaccine and therapeutic trials, showcased the country's clinical research base at its best, through "a dynamic partnership of government, academia, industry, the NHS and the public". However, the UK had been falling behind in its commercial clinical trials activity, with the number of patients enrolled onto commercially led studies supported by the National Institute for Health and Care Research dropping by 44% between 2017-18 and 2021-22. At the same time, the UK had fallen from 4th to 10th best in the world for the number of trials initiated.
In the foreword to his report, Lord O'Shaughnessy warned that losing global ranking would lead to diminished opportunities for UK patients to get early access to innovative treatments, whilst therapies and healthcare services that would otherwise have been funded by the pharmaceutical and technology sector would instead have to be paid for by taxpayers.
His stated aim was that the Government should aim to double the numbers of people taking part in commercial clinical trials in the next 2 years and double it again by 2027.
NHS Integral to Clinical Trial Activity
In the review, Lord O'Shaughnessy said he was concerned that research was "not systematically prioritised by or within the NHS" and called for research and development targets to be introduced in the NHS "at every level". He recommended that income generated by commercial sponsors should be explicitly directed to units and departments responsible for trials on NHS sites to provide direct financial incentives.
Similarly, the contribution of primary care to clinical trial activity was "negligible", and he recommended that GPs should be similarly incentivised to conduct community drugs and treatment trials, backed by new primary care research networks.
The report also recommended a series of measures to ensure that the UK took advantage of the NHS's large data assets.
UK governments should hold a competition to establish clinical trial acceleration units that would be funded to deliver best-in-the-world clinical trials services in critical strategic areas of the health and life sciences. Those could include neurodegenerative disease and respiratory disease, or areas of science where the UK had global leadership, such as cancer vaccines or cell and gene therapies.
An action plan should be developed, to report by autumn 2023, outlining how the Government and delivery partners will implement the recommendations of this review. The Life Sciences Council should provide objective accountability for the delivery of this action plan by the government and its agencies.
"If the UK is truly going to be a science superpower, we have to use every asset at our disposal", Lord O'Shaughnessy said.
The Government said it welcomed all the review's recommendations and accepted that "there is significant work to do". It promised, as a first step, to deliver five upfront commitments, backed by £121 million, focused on speeding up and approving clinical trials, making it easier for patients to find trials, and proactively finding patients who could benefit from innovative treatments in key areas such as cancer and infectious diseases. The money was part of a wider commitment of £643 million to boost the sector.
Work would start immediately, with progress reported to the Life Sciences Council, and an implementation update published this autumn.
'Helpful and Timely' Report
Commenting on the review's findings and the Government's response to the Science Media Centre , Sir Martin Landray, professor of medicine and epidemiology at the University of Oxford, described the report as "helpful and timely", and said that some of the recommendations could "with the right willpower, be enacted very fast". Prof Landray, who is co-chief investigator of the RECOVERY Trial into treatment drugs for COVID-19, identified the fragmented approach of the NHS to clinical trials as "a widespread and long-term source of frustration".
Nikola Sprigg, professor of stroke medicine at the University of Nottingham, commented that doctors, nurses, and clinicians wanted to be involved in research but often faced " multiple delays, barriers, and risk adverse complexities".
Some commentators highlighted the pressures faced by the NHS as a potential problem. Dr Ian Walker, executive director of policy, information, and communications at Cancer Research UK, said unless immediate action was taken to "address the lack of time and capacity available for research within the NHS", the UK would "lose the chance to lead globally renowned clinical trials in the future as trial sponsors look to other countries with better infrastructure already in place".
Prof Sir Martin Landray is Chief Executive of Protas, a non-profit organisation focussed on facilitating smarter randomised trials for common health conditions, and Professor of Medicine & Epidemiology at University of Oxford. He was appointed by Wellcome Trust and Bill & Melinda Gates Foundation to lead the Good Clinical Trials Collaborative. He co-leads the RECOVERY trial of treatments for patients hospitalised with COVID-19. His work receives funding from the pharmaceutical industry, government, charitable and philanthropic organisations through grants to Oxford University and to Protas. Prof Nikola Sprigg declared research funding from charities and the NIHR.