The head of a review examining the reasons for a dramatic drop in clinical trials in the UK is urging the government to bring research out of overwhelmed hospitals and into pop-up locations, potentially modelled on those used for Covid-19 vaccinations.
James O’Shaughnessy, former life sciences and innovation minister, has been investigating the 41 per cent fall in the number of industry clinical trials in Britain since 2017.
O’Shaughnessy’s report, due in the coming weeks, will find that trials are being slowed down by sluggish hospital governance procedures and doctors with little time to enrol patients, according to people familiar with the draft proposals.
During the Covid-19 pandemic, health services adopted new models for conducting trials outside hospitals, when coronavirus jabs were distributed in stadiums and car parks across the UK.
Health companies have been trialing different templates. US biotechnology group Grail, which is undertaking the world’s largest trial of a blood test to detect cancer in the UK, is using mobile clinics in retail parks and other locations, partly to ensure a diverse range of participants. Grail worked with the NHS to find 140,000 participants who met the criteria.
The review will conclude that significant staff cuts at the medicines regulator since the UK left the EU have delayed the start of trials, the people said.
In his Budget last month, chancellor Jeremy Hunt announced £10mn for the Medicines and Healthcare Products Regulatory Agency to accelerate the rollout of cutting-edge medical products.
He pledged to speed up the approval system for new drugs by introducing a plan for the MHRA to accept approval decisions by regulators in US and EU, freeing up its resources by removing the need to approve all new medicines.
The MHRA said it is aware that industry and researchers are “experiencing extended timeframes” in clinical trial applications, adding that it is putting more resources in high areas of demand. “We always prioritise applications where there is a risk to patient or public health,” it said.
The UK has tried to promote the NHS as an ideal location for clinical research, enabling pharmaceutical companies to easily access large patient populations, because of the single healthcare system.
The Life Sciences Vision road map, developed jointly in 2021 by the government, NHS and life sciences sector, set out an ambition to widen access to the health service to boost innovation, despite the UK only having a small drugs market and paying less for medicines than many developed countries.
The UK dropped from the fourth most popular country to conduct late stage clinical trials in 2017 to the 10th in 2021, according to data collected by the Association of the British Pharmaceutical Industry, an industry body.
The ABPI is pushing the government to prioritise industry clinical trials, rather than academic studies, which would also generate revenue for the NHS, and to streamline approval procedures.
Novartis scrapped a major trial late last year that would have enrolled 40,000 patients, after a slow rollout of its drug to lower cholesterol. People close to the programme said many GPs had been reluctant to prescribe it, despite the high-profile partnership with the NHS.
The UK government said the review will recommend a shortlist of “priority actions”, as well as taking a view on longer term ambitions for UK clinical trials.
“This will ensure growth opportunities are maximised, and expedited progress is made to resolve key challenges in conducting commercial clinical trials in the UK,” they said.
Additional reporting by Sarah Neville in London