Executive summary and action required

The Government published the Life Science Sector Plan (LSSP) in July this year which followed Fit for the Future: 10 Year Health Plan for England (10 Year Plan) and built on commitments for the NHS to work in partnership with Industry for a thriving life sciences ecosystem in the UK. The LSSP details six headline actions including the Prime Minister’s commitment to cut clinical trial set up times to 150 days or less and to increase trial activity in the NHS.

Research activity in the NHS benefits patients, staff and NHS organisations directly and there are significant opportunities for NHS organisations in increasing research activity. Despite significant effort the UK has not recovered commercial clinical trial activity and performance well enough to be competitive in the international market.

This paper outlines NHS England’s current work to deliver on the commitments in both the 10 Year Plan and the LSSP in relation to clinical trials and the board is asked to consider if this work is addressing the right outcomes and where we could go further faster.

The Board is specifically asked to consider and discuss:

1. How do we support the regions in their role of overseeing research performance and activity and understand if there is the capability and capacity to deliver the government’s ambitions for research in the NHS?
2. Are there any areas of additional activity or incentives that we need to consider to go further faster on this agenda?
3. What are the board’s views on using the NHS planning guidance to support the delivery of the LSSP actions?

Background

1. On 16 July 2025 the Government published the Life Sciences Sector Plan. This strategy plays a unique role in the economy, raising productivity and supporting exceptionally valuable jobs while also boosting growth indirectly by improving the health of the population via alignment to the 10 Year Plan. To achieve the ambition that by 2030 the UK will be the leading Life Sciences Economy in Europe the plan sets out commitments to deliver on three pillars of activity:

1. Supporting world class R&D,
2. Making the UK an outstanding place in which to start, grow, scale and invest,
3. Driving health innovation and reform

2. The plan sets out 33 specific actions across these three pillars with a named senior responsible officer for delivery and metrics to track progress. These actions are summarised at Appendix 1.

3. Initial efforts for delivery will be focused on the six headline actions outlined below which are critical to the success of the strategy.

1. Realising a Health Data Research Service (HDRS), to create the world’s most advanced, secure and AI-ready health data platform. This will unite genomic, diagnostic, and clinical data at population scale, turning NHS and wider healthcare data into a magnet for global trials and AI investment. 
2. Slashing trial set up times to under 150 days by implementing the O’Shaughnessy reforms and placing a dual health and growth mandate on the National Institute for Health and Care Research (NIHR), we will cut delays that deter investors and aim to double commercial interventional trial participants by 2026 and again by 2029. 
3. Backing manufacturing with up to £520 million through the Life Sciences Innovative Manufacturing Fund, which will bring globally mobile manufacturing investments to the UK. This will help build and maintain the UK’s critical sovereign capability across the sector, creating high-value jobs nationwide, and strengthening domestic health resilience and supply chain security. We have also developed a new, bespoke approach to supporting investments over £250 million. 
4. Streamlining regulation and market access by supporting the Medicines and Healthcare products Regulatory Agency (MHRA) to become a faster, more agile regulator, and giving industry a clearer route to market through joint advice and parallel approvals with the National Institute for Health and Care Excellence (NICE) alongside a route for international reliance for medicines and medical devices so patients benefit sooner from cutting-edge innovation. To support our ambition to become one of the top three fastest places in Europe for patient access to medicines, we will accelerate growth in net spend on innovative medicines over the course of this plan compared with the previous ten years – particularly those medicines that help keep people out of hospital.
5. Introducing low-friction procurement by streamlining the route to procurement, ensuring it is clearer and less bureaucratic, giving industry low-friction access to the NHS through a Rules Based Pathway for MedTech and an NHS ‘Innovator Passport’, enabling innovative MedTech products to reach patients more quickly. At the recent Life Sciences Delivery Board, a deep dive was conducted into this headline action in which the board explored how the NHS could be a better customer on MedTech procurement.
6. Partnering with industry to drive growth and innovation. We will secure at least one major strategic partnership annually with leading Life Sciences companies. A dedicated support service will also be established to help 10–20 high-potential UK companies scale, attract investment, and remain headquartered in the UK

4. This paper provides an update for the board on our work to deliver on the second of these headline actions to slash trial set up times and increase research activity which is also echoed in the 10 Year Plan along with a focus on the NHS working in partnership with industry to deliver a thriving life sciences ecosystem.

5. The benefits of research in the NHS are well documented and present significant opportunities for NHS organisations:

1. Patients benefit from earlier access to new treatments and technologies
2. Research active hospitals have lower mortality rates and patients’ perception and experience of care is higher in research active organisations
3. Staff have increased job satisfaction with improved recruitment and retention when staff are enabled to be involved in research.
4. The NHS generates income from research activity:
   1. Clinical trials funded by members of the Association of British Pharmaceutical Industries (ABPI) in 2022/23 led to £1.2 billion of income for the NHS. 
   2. In 2023/24 the National Institute for Health and Care Research (NIHR) provided £1.3 billion of research funding.
   3. In 2022/23 150 members of the Association of Medical Research Charities funded £1.7 billion of medical research

6. Commercial trial income also provides the opportunity for NHS organisations to build capacity and capability for research of all types at the same time as creating cost savings from trials providing drugs free of charge and funding trial participants’ care that would otherwise have been funded via the NHS.

7. The board is asked to note progress and identify any additional activities/incentives we should consider to further increase research activity in NHS organisations.

Current work to increase activity and improve trial performance

8. Despite significant efforts by the system to recover research activity in the NHS post pandemic, the UK is still lagging behind our European neighbours in competitiveness ratings for commercial clinical trial activity. Regulatory approval timelines have improved significantly but we are consistently missing key performance indicators (KPIs) for speed.

9. The 150 day target for trial set up requires organisations to consistently meet the KPIs to a) open studies to recruitment within 60 days of regulatory approval or site selection and then b) recruit the first patient within 30 days of the site opening. Performance will be monitored via the publication of both aggregate study level set up times and individual site level performance data.

10. NHS England is a partner in the DHSC led UK Clinial Research Delivery (UKCRD) programme, a UK sector-wide partnership responsible for delivering improvements in the UK clincial trial performance and extensive work has already taken place to deliver on the published set up plan specifically aimed at delivering the 150 day target. This includes introduction of a standardised contracting process and streamlined study set up that reduces duplication in organisations and delivers a “do once only” approach to trial set up. NHS England will mandate use of the standardised commercial contracting process by the end of September 2025 via our existing national directive for commercial trials which is underpinned by the NHS Standard Contract. Our next steps are to ensure compliance by organisations working with our partners in the National Institute of Health and Care Research (NIHR), Research Delivery Network (RDN) and the Health Research Authority (HRA). We have also requested that compliance with the set up process and meeting the site level KPIs is included in the medium term planning guidance.

11. This work builds on NHS England’s National Contract Value Review (NCVR) process, which negates the need for multiple negotiations on trial costing, and which has already contributed to reduced set up times by over a third.

12. To ensure organisations are maximising the opportunities created by participating in research, and following discussion at the NHS England Executive meeting, we have also written to NHS Chief Finance Officers (CFOs) and R&D Directors with a set of requirements aimed at increasing the visibility of research at board level and maximising the benefits from research activity. Organisations are required to:

1. 1. comply with the terms and conditions attached to any research income from outside the NHS HM Treasury allocations, and use this funding for its intended purpose, including recruiting to R&D posts.
   2. establish board-level reporting of research activity and income, with scrutiny of the UK Clinical Research Delivery (UKCRD) programme site level performance metrics for study set-up.
   3. ensure all commercial trial activities are invoiced in a timely manner.
   4. follow the existing NHS England and NIHR guidance on investing capability and capacity income from commercial trials.

13. We have also contributed to the Model Region workstreams to ensure that research leadership functions are maintained in the system. We will work with regions to support their role to oversee performance and activity and understand if they have the capacity and capability to deliver on the government’s ambitions.

14. In addition to this work and in response to feedback from industry trial sponsors that some NHS organisations are not invoicing for commercial trial activities we are also:

1. holding a series of round table events in September 2025 with CFOs, Medical Directors, Nursing Directors, R&D Directors and operational managers to better understand issues related increasing research activity and managing research finances. Using the intelligence from these conversations we will update the NHS England Research Finance guidance (published originally in 2024) and build learnings into our delivery with UKCRD.
2. working with the NHS England CFO team who have included commercial trial cost recovery in a list of financial “grip and control” areas for organisations. We will also work with the team to support conversations at regional level based on intelligence provided by industry sponsors on delayed cost recovery.
3. ensuring alignment of NCVR with NHS payment systems guidance to support embedding research finance in general finance systems.

Considerations and requests of the board

15. The Board is asked to note the work outlined above to increase research activity and performance in the NHS and to consider the following questions:

1. Are we working to achieve the right outcomes for research in the NHS?
2. How do we support the regions in their role of overseeing research performance and activity and understand if there is the capability and capacity to deliver the government’s ambitions for research in the NHS?
3. Are there any areas of additional activity or incentives that we need to consider to go further faster on this agenda?

Appendix 1 – Summary of LSSP specific actions