Transforming the UK clinical research system: August 2025 update
Published 4 August 2025
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Overview
The government is committed to delivering a transformative vision for the NHS and advancing research and innovation for the life sciences sector in the UK, with a focus on 3 core reform shifts:
- hospital to community
- analogue to digital
- sickness to prevention
These shifts are a fundamental part of the government’s health mission and the government’s vision for clinical research is aligned to the goals of the health and growth missions, with 4 pillars to:
- improve timely access to health and care research
- support a research portfolio that tackles the major killers
- reduce inequalities through research inclusion towards a fairer Britain
- offer a world-leading environment for life sciences to undertake research
By fostering cutting-edge research and innovation to encourage breakthroughs in life sciences, we will aim to ensure a healthier population, allowing patients to access novel treatments and ensure a health system that is more accessible, efficient and sustainable to build an NHS fit for the future, as recently set out in Fit for the future: 10 Year Health Plan for England, the Plan for Change and the Life Sciences Sector Plan. This includes the Prime Minister’s commitment to help strengthen the UK’s position as a global leader in clinical trials and medical research, setting ambitions for clinical trials - ensuring the system is going further and faster by cutting study set-up times to 150 days or less.
The Department of Health and Social Care (DHSC) currently invests £1.6 billion each year on research through its research delivery arm, the National Institute for Health and Care Research (NIHR). The NHS benefits from additional revenues and cost savings from clinical research, particularly from large late-phase interventional studies. Based on data shared by NIHR, the average per-patient payment NHS income in 2022 to 2023 across commercial studies sponsored by the then NIHR Clinical Research Network (CRN), now known as the NIHR Research Delivery Network (RDN), was £26,311 (£28,808 once adjusted for inflation to 2024 prices).
The following update sets out how the government is working to transform the UK clinical research system and includes an overview of progress that goes beyond implementing Lord O’Shaughnessy’s recommendations, across the UK Clinical Research Delivery (UKCRD) programme.
UK Clinical Research Delivery
The government is fully committed to working with partners across the system and the devolved governments through UKCRD, a cross-sector collaborative programme to make the UK a world leader in clinical trials.
The UKCRD programme is setting out a bold plan for clinical research across all 4 nations, to make tangible and lasting improvements to the UK clinical research system and presenting our research delivery metrics against the 4 health and growth mission pillars mentioned above.
To do this, we will particularly work on improving timely access to health and care research, which will explicitly support the goal of offering a world-leading environment for life sciences research, therefore prioritising work to:
- streamline and reform the set-up and delivery of clinical trials through digitalisation and reducing unnecessary bureaucracy
- drive a ‘right research, right setting’ initiative, to include a radical move to research delivery in primary and community care
- move from a reactive to a proactive model of portfolio management
VPAG investment programme
Implementing the investment programme for Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) will speed up delivery of commercial research in the UK by improving workforce capacity, resources and infrastructure. This includes the commissioning of new commercial research delivery centres (CRDCs) across England (through NIHR) and the devolved governments.
Workstreams in the UKCRD programme
UKCRD programme workstreams include, but are not limited to, the following.
Delivering the enhanced Study Set-Up Plan
The Study Set-Up Plan, led by DHSC, is being delivered through the UKCRD programme to streamline and reform the set-up and delivery of all clinical trials through digitalisation and reducing unnecessary bureaucracy to rapidly address the delays affecting clinical research. The plan reflects initial prioritised actions to meet the government’s 150-day target for clinical trial study set-up, by cutting the time taken between regulatory approval to sites opening for recruitment, and subsequently the time between sites opening to recruitment and first participants recruited. The outputs of this plan are being delivered this year, with phase 1 deliverables published in April 2025 and phase 2 deliverables published in June 2025.
The successful implementation of the plan will be closely monitored for impact. Monitoring will be undertaken by DHSC and partners through focused stakeholder engagement - through workstream task and finish groups - and collaboration and wider communications through the UKCRD programme governance structures. The UKCRD programme will work closely with CRDCs to push this ambition and radically reduce the set-up timelines, building on these initial prioritised actions and leading innovation in commercial clinical study set-up
Driving a ‘right research, right setting’ initiative
This will ensure that research is delivered in the most appropriate environment for the study design, including building capacity in primary care and community settings and ensuring research opportunities are made available to patients where they access care. This will allow a broader proportion of the population to access research and participate, bringing research to the patient.
Moving from a reactive to a proactive model of portfolio management
The review recognised the extent of existing interactions that NIHR has with industry. NIHR has set up an industry advisory group to oversee the implementation of a number of recommendations, including strengthening NIHR’s offer to small and medium-sized enterprises, improving management with key pharmaceutical accounts, to move from a reactive to proactive model of portfolio management.
The continued cross-sector collaboration will be an essential part of reforming and transforming the UK’s clinical research system.
While the HDRS programme is not part of UKCRD workstreams, these programmes are closely aligned and wider progress as part of this programme, outside UKCRD, is therefore not included in this report.
The tables below set out an overview of progress (including complete and outstanding actions) that go beyond implementing Lord O’Shaughnessy’s recommendations. We will incorporate any actions outstanding into a new UKCRD framework, to have a consistent and coherent plan of work.
Update on commitments to achieve Lord O’Shaughnessy’s recommendations
Note: the themes set out in the tables in this section refer to previous government policy.
Table 1a: costing and contracting commitments
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| Enhanced national contract value review (NCVR) approach introduced (led by NHS England) | Complete (From October 2023) |
The NCVR approach for all late-phase commercial trials carried out in acute, specialist and mental health trusts (phase 2b and above) was introduced across the UK in October 2023 |
| Monitor both NHS and industry adherence to the single national review and standard contracts (led by NHS England) | Complete (By December 2023 and ongoing) |
The NCVR England Governance Group are continuing to monitor adherence to the NCVR approach |
| Achieve a national performance indicator of 100% of sites in England accepting the local price generated as part of the NCVR process without further negotiation, for late-phase studies and following agreement by the lead site of the resource required (led by NHS England) | Complete (By December 2023) |
100% of NHS trusts in England now accept the local price generated by the NCVR process. 515 GP practices have now signed up to the voluntary NCVR scheme |
| Enhanced NCVR approach starting to be piloted in early phase and advanced therapy medicinal product (ATMP) studies (led by NHS England) | Complete (By December 2023) |
Following a successful pilot and early development phase, NCVR is now the ‘business as usual’ costing methodology for all ATMP and early-stage commercial studies since October 2024 |
Table 1b: 60-day turnaround time for all approvals maintained
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| Medicines and Healthcare products Regulatory Agency (MHRA) to launch a new notification scheme | Complete (From October 2023) |
DHSC will continue to work with MHRA to ensure the 60-day turnaround time for approvals is maintained |
| MHRA and NHS Health Research Authority (HRA) clinical trials public consultation task and finish group starts and reports, led by MHRA and HRA | Complete (By January 2024) |
The new clinical trials regulations were laid in December 2024 and will come into force on 28 April 2026. New guidance to accompany the regulations has been published |
Table 1c: establish clinical trials delivery accelerator
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| Appoint clinical trial delivery accelerator host organisation (led by DHSC and devolved governments) | Complete (By February 2024) |
Explore how evaluation and insights from the accelerators (particularly on faster setup) will inform other work |
Table 1d: provide real-time data on commercial clinical activity in the UK
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| New sponsor engagement tool implemented by NIHR (led by NIHR) | Complete (By December 2023) |
NIHR will continue to improve this tool and is engaging with sponsors regularly to ensure it continues to be used effectively |
| Discovery work completed in full, providing essential foundations for effective implementation (led by NIHR) | Complete (By April 2024) |
Initial discovery work completed to inform the implementation plan. Implementation of developments now underway |
| Publish implementation plan for delivery in financial year 2025 to 2026, subject to business case (led by NIHR) | Complete (By April 2024) |
Now integrated into UKCRD workstreams, see below |
Table 1e: establish a common approach to contacting patients about research
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| Publish details of further actions based on the recommendations to support data enabled delivery of research (led by DHSC and devolved governments) | Complete (By end of 2023) |
Completed. Published on the HRA website |
| Final conclusions and recommendations will be published by the end of 2023. We will publish details of further actions based on the recommendations to support data enabled delivery of research April 2024 (led by HRA) | Complete (By April 2024) |
Now integrated into UKCRD workstreams, see below |
Table 1f: UK performance indicators
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| Introduce new UK performance indicators with immediate effect (led by DHSC and devolved governments) | Complete (Ongoing) |
Review the current performance indicators to ensure they remain stretching, and are driving progress in the right areas |
| Publish progress updates on a monthly basis (led by DHSC and devolved governments) | Complete (Ongoing) |
The UK performance indicators will continue to be published monthly |
| NHS England will develop a set of metrics which help integrated care boards and NHS providers understand their research performance (led by NHS England) | Complete - guidance is planned to be published in autumn 2025 (End of financial year 2024 to 2025) |
Metric development is complete NHS England is publishing the Research Activity Framework and Guidance in autumn 2025 |
Table 1g: clinical research delivery embedded in the NHS
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| Updated General Medical Council (GMC) good medical practice guidance comes into force in January 2024 (led by GMC) | Complete (By January 2024) |
Continue to embed good practice and guidance |
| NIHR CRN fully implements the new approach to performance monitoring initiated through Research Reset programme (led by NIHR) | Complete (By March 2024) |
RDN (previously CRN), will continue to provide support and/or advice on study performance and support issue resolution upon request of the sponsor or their delegate (rather than undertaking individual study monitoring) |
| The Association of Medical Research Charities (AMRC), DHSC and NIHR will publish by March 2024 a plan to work together to promote the benefits of clinical research to people working in the health and care system, patients and service users and the general public (led by AMRC, DHSC, NIHR and devolved governments) | Complete (Updated to May 2025) |
The benefits of clinical research have been woven into Chief Scientific Adviser presentations and used to underpin various publications across the health and care system to signify the importance of clinical research to improve patient outcomes, including the UK Research Workforce Strategy, Missions and 10 Year Health Plan. Internationally, other countries are also learning from our portfolio approach, through the World Health Organisation Global Clinical Trials Forum A public communications campaign was launched for the Be Part of Research registry in June 2025 See Embedding a research culture |
| NIHR develops and implements an improved national process for faster industry site selection, details will be published by March 2024 and full implementation of changes in place by October 2024 (led by NIHR) | Complete (By October 2024) |
Site selection tool launched for England March 2025 Note that there were initial delays in issuing licences at DHSC which were a dependency for project commencement. The NIHR RDN will implement a new approach to identify sites, speeding up study delivery and ensuring a more transparent approach to site selection |
| Contract for the new NIHR RDN begins (led by NIHR) | Complete (In 2024) |
The RDN Co-ordinating Centre commenced in April 2024 and the regional network contracts started in October 2024. Information and updates on the transition to the RDN |
Table 1h: streamlined, efficient and innovative clinical research
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| DHSC, the devolved governments, NHS England, HRA and NIHR will publish guidance and implement processes to improve site and sponsor engagement (led by DHSC and devolved governments) | Complete (By March 2024) |
In 2024, the Clinical trials best practice guide 2024 was published identifying where reciprocal improvements can be made to help improve clinical trial set-up processes in the UK DHSC has also launched its sector wide study set-up plan to go faster and further than the work originally intended, see table 2c below |
| NIHR CRN new approach to performance monitoring fully implemented (led by NIHR) | Complete (By March 2024) |
DHSC will closely monitor and evaluate the progress of the NIHR RDN transition and new initiatives |
| In April 2024 NHS England will publish research finance guidance (led by NHS England) | Complete (In April 2024) |
See Managing research finance in the NHS. In May 2025 NHS England’s National Director of Transformation wrote to provider CFO and directors of R&D setting out best practice in the oversight and staffing of clinical research |
| From April 2024 DHSC and HRA, on behalf of the devolved governments, will expand the cohort of professionals across the UK providing pharmacy technical review and support uptake of these national reviews in local practice (led by DHSC, HRA) | Complete (From April 2024) |
£15.75 million over 3 years (starting financial year 2024 to 2025) has been allocated to research-active NHS trusts to help address blockages in set-up due to delays in pharmacy services DHSC through the HRA will fully embed HRA technical assurance guidance for pharmacy and explore mandating this guidance |
Table 1i: people-centred research delivery
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| HRA, DHSC, NHS England and devolved governments will identify actions to be taken as a result of the HRA ‘hallmarks’ of people centred research report (led by HRA, DHSC, NHS England, devolved governments) | Complete (By March 2024) |
Work to embed the ‘hallmarks’ of good clinical research across the system; ensuring these principles are embedded into BAU |
| In financial year 2024 to 2025 NHS England and DHSC will continue to support the Integrated Care System Research Engagement Network development programme (led by NHS England) | Complete (In financial year 2024 to 2025) |
DHSC and NHS England have committed to fund the Integrated Care System Research Engagement Network programme in 2025 to 2026 |
Table 1j: a sustainable and supported research delivery workforce
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| NHS England will publish a multi-professional practice-based research capability framework for the healthcare professionals (led by NHS England) | Complete (By spring 2024) |
Guidance was published in February 2024 to support the involvement of the NHS workforce in health and social care research. The multi-professional practice-based research capabilities framework highlights and promotes active involvement in research as an integral component of practice for practice-based health and care professionals |
| DHSC and the devolved governments will continue to provide funding for NHS support costs (for example, through the NIHR RDN for England) (led by DHSC and devolved governments) | Complete (From October 2024) |
Ongoing business as usual activity |
| DHSC will develop and publish a workforce plan in support of The Future for UK Clinical Research Delivery (led by DHSC) | During 2024 (Updated to autumn 2025) |
Now integrated into UKCRD workstreams, see below |
Table 1k: research delivery enabled by data and digital tools
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| 1 million people have registered on Be Part of Research by March 2025 (led by NIHR and NHS England) | By March 2025 (New stretch target of 2 million people by March 2026) |
Now integrated into UKCRD workstreams, see below |
| By April 2025 the NHS Research Secure Data Environment network will support over 500 users and 450 research projects through privacy-protecting accelerated access to multimodal data, including genomics, and over 45 million primary care records (led by NHS England) | Integrated into data for R&D and HDRS programmes (By April 2025) |
As of March 2025, the network has supported 834 users, 105 projects have been completed with 314 projects live across the network. This equates to 419 projects delivered and/or in progress across both regional and national secure data environments 85 further projects are in pipeline which are at the point of having a data access request granted or waiting on it to be granted |
| Subject to successful discovery work by April 2025 local, regional and charity research volunteer registries will have the opportunity to link to Be Part of Research to form a national networked database of interested volunteers in research (led by NHS England, NIHR) | Further action ongoing (By April 2025, subject to Government Digital Service (GDS) approval) |
Discovery work has been completed and substantial further development of the Be Part of Research service is planned to enhance user experience and improve its performance at linking people to studies that are relevant to them |
| Continue to refine use cases and set out the case for implementation of data enabled approaches at scale in future (led by DHSC) | Integrated into data for R&D and HDRS programmes (Ongoing, to enable post-2025 response - the PM’s announcement set out that HDRS would “begin from the end of 2026”) |
On 7 April 2025, the Prime Minister announced that the government and the Wellcome Trust will invest up to £600 million to create a new HDRS. This ground-breaking initiative will deliver significant health benefits to the UK public and patients. HDRS will deliver a single point of access to health data from multiple sources DHSC and NHS England are working across government to set up and deliver HDRS |
Going beyond the Lord O’Shaughnessy review
UKCRD programme activity and Study Set-Up Plan - ongoing actions
Table 2a: commitments carried forward under the UKCRD programme
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| Provide real-time data on commercial clinical activity in the UK, research delivery, data and intelligence. Publish implementation plan for delivery in financial year 2025 to 2026, subject to business case (led by NIHR) | Now integrated into UKCRD workstreams (By April 2024) (Reviewed and updated to January 2026) |
January 2026 - NIHR to publish research delivery data at site, regional and national level, by research topic, for commercial and non-commercial portfolio studies, updated at least monthly in the first instance |
| Establish a common approach to contacting patients about research: final conclusions and recommendations will be published by the end of 2023. We will publish details of further actions based on the recommendations to support data enabled delivery of research April 2024 (led by HRA) | Further action ongoing (By April 2024) (Reviewed and updated to publication in August 2025) |
Subject to working through outstanding legal issues and final consultation, we will publish a common approach to contacting patients about research with NHS England, the HRA and other partners Aim to publish final conclusions and recommendations (HRA report) August 2025, with further actions and implementation plan to follow |
Table 2b: research delivery enabled by data and digital tools
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| DHSC will develop and publish a workforce plan in support of The Future for UK Clinical Research Delivery (led by DHSC) | Further action ongoing, now aligned with 10 Year Health Plan (Autumn 2025) |
This government will publish a research delivery workforce strategy and a detailed implementation plan in autumn 2025 |
| 1 million people have registered on Be Part of Research by March 2025 (led by NIHR, NHS England) | Further action (By March 2025) (Reviewed and updated to 2 million people by March 2026, stretch target) |
Be Part of Research has received GDS accreditation. In June 2025, after a successful beta phase, the recruitment campaign began. This sustained, extended campaign will last 18 to 24 months. We have set a new stretch target of 2 million sign-ups by March 2026 |
Table 2c: reaching 150-day target for setting up clinical trials
| Commitment | Status (original/updated implementation timings)s | Summary |
|---|---|---|
| Issue unmodifiable confidentiality disclosure agreement template to streamline and minimise negotiation between sponsors and sites (led by NHS England and HRA) | Complete April 2025 |
Notified commercial sponsors 28 April 2025 wishing to enter into a confidential disclosure agreement (CDA) with prospective NHS research sites, that an unmodified model CDA must be used to cut unnecessary duplication and streamline contracting. HRA to evaluate use and NHS England to mandate later on this year |
| Identifying negotiations of costing and contracting that fall outside of the mandated NCVR process (such as pass through costs, for example, travel). And inclusion of non-industry costing tool (iCT) activity (such as archiving and travel costs) in the unmodifiable contract | Complete (May 2025) |
Discovery work to identify non industry costing tool activities completed in full Improved unmodifiable model commercial contract agreement published in mid-May 2025 |
| Issue new unmodifiable Chief Investigator Agreement template and guidance to improve and streamline NCVR negotiations and processes (led by NHS England and HRA) | Complete May 2025 |
Published a new model Commercial Chief Investigator Agreement on 28 April 2025 which aims to reduce unnecessary negotiation during contracting. HRA to evaluate use and NHS England to mandate later on this year |
| Kick-start early adoption of new HRA pharmacy guidance through Experimental Cancer Medicine Centres Network to streamline pharmacy technical assurances (led by HRA) | Ongoing (April 2025) |
Pilot launched on 28 April 2025 with the Experimental Cancer Medicine Centres Network to test a streamlined study set-up pathway and mandated UK Pharmacy Assurance. This pilot seeks to develop a new process which aims to remove duplication of UK study-wide reviews and improve the use and impact of pharmacy technical review information |
| Initiate prioritised actions from the HRA 7-point action plan to address information governance, removing unnecessary duplication of information governance assurance at sites (led by HRA) | Complete (April 2025) |
HRA has shared an update on their previous blog on information governance, initiating the 3 prioritised steps HRA will be undertaking to improve confidence in UK study-wide reviews for information governance to streamline checks during study set-up |
| Issue new guidance with inspectorate and professional bodies to radiation specialists to mitigate risk-averse behaviours that lead to duplication of checks during set-up for studies requiring imaging (led by HRA) | Ongoing (June 2025) |
Issue new guidance with inspectorate and professional bodies to radiation specialists to mitigate risk-averse behaviours that lead to duplication of checks during set-up for studies requiring imaging (led by HRA) |
| Maintain combined MHRA and HRA approval timelines of 60 days (led by MHRA, HRA) | Ongoing | Ongoing monitoring through the monthly UK key performance indicators (KPI) report |
Table 2d: delivering transparent data at site and study level
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| DHSC and/or NHS England issue new requirement for NHS trusts to provide additional data to enable visibility of study set-up performance at site level (2 commercial KPIs), increasing transparency and supporting more proactive portfolio management (led by DHSC, NHS England) | Complete (March 2025) |
Study Set-Up: latest news |
| Publish site-level study set-up data to enhance transparency of reporting for the 2 current commercial set-up KPIs (led by DHSC) | Complete (April 2025) |
Enhanced visibility of site level performance for the following 2 metrics published by DHSC in April 2025: - proportion of commercial contract studies open to recruitment within 60 days of HRA approval letter - proportion of commercial contract studies recruiting first participant within 30 days of sites opening to recruitment |
| Closely monitor the impact of study set-up plan interventions on performance against the 2 commercial KPIs to inform new milestones for these 2 KPIs (led by DHSC) | Ongoing (May 2025 to December 2025) |
Monitoring ongoing |
Table 2e: improving the wider research system
| Commitment | Status (original/updated implementation timings) | Summary |
|---|---|---|
| Issue unmodifiable model non-commercial agreement and organisation information document template to streamline and minimise contract negotiation (led by NIHR) | Complete (June 2025) |
Study Set-Up Plan: phase 2 completed in June 2025 stating position for NIHR portfolio studies |
| Issue new requirement to designate a schedule of events cost attribution tool as non-negotiable after HRA approval, reducing unnecessary duplication of site level cost negotiation (led by NIHR) | Complete (June 2025) |
Study Set-Up Plan: phase 2 completed in June 2025 stating position for NIHR portfolio studies |