The government is aiming to quadruple the number of patients taking part in commercial clinical trials in the next four years as part of an ambitious plan to boost UK life sciences.
Unveiling a package of measures for the sector, the chancellor, Jeremy Hunt, said patients would get quicker access to new medicines and the government would cut the bureaucratic burden of approving clinical trials, which has been blamed for a rapid decline in NHS-based trials for cancer and Alzheimer’s drugs. Other measures announced include funding for an upgrade of the UK Biobank and details of a proposed train route between Oxford and Cambridge.
“It’s a very important part of the offer to life science companies that they don’t just do their R&D [research and development] here, but they’re able to trial their drugs on human beings,” Hunt said. “The data you get from that is the most valuable of all.”
The new policies aim to reverse a collapse in commercial clinical trials in the NHS, with a 44% drop in participants recruited since before the pandemic from more than 50,000 in 2017 to about 28,000 in 2021. The UK is also losing ground to countries such as Spain, Poland and Australia.
A government-commissioned review into the decline, led by former health minister James O’Shaughnessy, will be published on Friday and sets out a range of ambitious targets. This includes the goal – which the government has accepted – of doubling patient participation in commercial trials within two years and doubling the number again by 2027. To achieve this, the review recommends offering financial incentives to GPs to increase recruitment through primary care and using the NHS app to inform patients about trials in their area.
It also calls for an overhaul of a sluggish regulatory process, highlighting backlogs at the regulator and in the bespoke processes for the set-up and costing of trials used by many trusts.
The latest performance data shows that the medicines and healthcare products regulator (MHRA) is now taking about 110 days to turn around clinical trial approvals – double the time it was taking a year ago. The government said it is pushing for a national “one contract fits all” approach and allocating an additional £3m to the MHRA to help it reach a goal of a 60-day turnaround time for all clinical trial approvals.
“We’re doing everything we can to get us back to the brilliant support for clinical trials we had in the pandemic,” said Hunt. “We know what we’re capable of in the NHS.”
Hunt added that overall pressures on the NHS may have contributed. “I don’t think it’s any secret that it’s been a period of very high pressure in the NHS with the backlog, post-pandemic, with a workforce that showed such incredible commitment in the pandemic but which are pretty exhausted,” he said.
Separately, the Treasury said it would give £150m in funding to expand the UK Biobank, including a move to a new facility in Manchester featuring a robotic freezer that stores and retrieves 20m biological samples that have been donated by UK Biobank’s 500,000 volunteer participants. A pilot “Yellow Card biobank”, run jointly by the MHRA and Genomics England, was also announced. The database will contain genetic data and patient samples and run alongside the MHRA’s Yellow Card reporting scheme for suspected side effects and adverse incidents involving medicines and medical devices.
Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry (ABPI), said: “Today’s announcements show that the government recognises the huge opportunity waiting to be grasped if the UK can unlock the economic potential of its life science industry – already worth £94.2bn in 2021. These measures demonstrate the government has listened to industry and will help put the UK on track to meeting its life science vision.
“Lord O’Shaughnessy is right that making the UK an attractive destination for industry clinical trials requires regulatory reform, speedier study set-up and approvals, and improved access to data.”