The UK government has officially responded to Lord James O'Shaughnessy's review of commercial clinical trials with a substantial financial commitment and ambitious targets to restore the country's position as a global leader in medical research.
Health and Social Care Secretary Victoria Atkins announced a £121 million funding package over the next three years to implement key recommendations from the review, which was commissioned in response to alarming declines in the UK's clinical research sector.
Government Pledges Ambitious Growth Targets
Among the headline commitments is a plan to dramatically increase clinical trial participation, with goals to double recruitment by 2025 and then double it again by 2027. This aggressive growth strategy aims to reverse what industry data had identified as a 41% decline in new study starts between 2017 and 2021.
"The review showed a welcome level of ambition," said Secretary Atkins, adding that the government shares "the desire to return the UK to its leadership role in commercial clinical research."
The response includes a target to substantially reduce approval times for commercial studies to 60 days, addressing one of the key competitive disadvantages that had led companies like AstraZeneca to cite reduced clinical trial capacity as a reason for locating new facilities outside the UK.
Early Signs of Recovery Emerging
Lord O'Shaughnessy, who led the independent review after being commissioned by the Office of Life Sciences (OLS), expressed cautious optimism about progress already made.
"The MHRA is performing much better, there is significant progress towards a national approach to contracting and costing, and most importantly the number of – and patients recruited to – industry-sponsored trials in the UK is growing again," he noted in a LinkedIn post.
This assessment is supported by recent data from the Association of the British Pharmaceutical Industry (ABPI), which reported a 4.3% increase in commercial trials conducted in 2022 compared to 2021. However, the organization emphasized that total numbers still fall well short of historical norms.
Streamlining Research Infrastructure
A central component of the government's strategy involves eliminating bureaucratic barriers that have hampered trial initiation and patient recruitment. The plan includes:
- A comprehensive and mandatory national approach to contracting to reduce administrative burden
- Implementation of 'real-time' data on commercial clinical activity, scheduled to roll out in 2025
- A common approach to contacting potential trial participants, with new guidance expected by year-end
- Establishment of specialized Clinical Trial Acceleration Networks (CTANs) in priority areas including infectious disease vaccines, cancer, and dementia
The Medicines and Healthcare products Regulatory Agency (MHRA) has already made significant progress by eliminating a backlog in research approval applications and introducing a new notification scheme for phase 4 and low-risk phase 3 clinical trials.
Industry Response and Ongoing Challenges
The clinical trials sector's decline had raised serious concerns about the UK's competitiveness in life sciences, which the government has identified as a pillar of the national economy. The 48% reduction in participation in phase 3 trials between 2017 and 2021 was particularly concerning, as these later-stage studies provide the NHS with the highest income.
Dr. Jennifer Harris, director of research policy at the ABPI, had previously emphasized that "addressing the worrying decline of industry-sponsored clinical research in the NHS is critical if we are to deliver the UK's ambitions for the life sciences sector and to support NHS recovery."
While the government's response has been welcomed by stakeholders, Lord O'Shaughnessy acknowledged that "there is still much to do" to regain the UK's globally-leading position in clinical research.
The implementation of these measures comes at a critical time, as separate regulatory arrangements between the UK and EU following Brexit have created additional challenges for the sector, according to warnings from the British Medical Association (BMA).
Future Outlook
The government's response represents a significant step toward rebuilding the UK's clinical trials infrastructure, with the £121 million investment signaling serious intent to address the sector's decline.
Success will ultimately be measured by whether the ambitious recruitment targets can be met and if the UK can once again position itself as a preferred destination for commercial clinical research, particularly for late-stage, industry-backed projects that have seen the steepest decline.
Health Minister Will Quince had earlier stated that the review would help "find new ways to conduct commercial clinical trials that will speed up diagnosis, enhance treatment and enable the NHS to deliver world-class care, as well as cementing our position as a life sciences super power."
