Part of Data for Research and Development Programme - Evaluation

Operational achievements

Context alongside Gateway 5 assessment

This programme evaluation was conducted following the development and publication of the Gateway 5 assessment. This evaluation is intended to be read in conjunction with the Data for R&D Gateway 5 assessment and does not seek to repeat in detail the findings from that assessment.

For context, the Data for R&D Programme Gate 5 assessment was Amber:

“Successful delivery of the programme/project to time, cost and quality appears feasible but significant issues already exist requiring management attention. These appear resolvable at this stage and, if addressed promptly, should not present a cost/schedule overrun.”

The Gateway 5 assessment noted that:

“the significant progress made towards the overall objectives despite the challenging environment and highlights, in particular the solid foundation on which to build.”

The Gateway 5 traffic light system

Green: Successful delivery of the project on time, budget, and quality appears likely. No major outstanding issues.

Amber: Successful delivery appears feasible, but significant issues already exist, requiring management attention. These are resolvable if addressed promptly, with no cost/schedule overrun.

Red: Successful delivery of the project appears unachievable. There are major issues with project definition, schedule, budget, quality, or benefits delivery, which at this stage do not appear to be manageable or resolvable

The Programme was established in 2022 with Gateway reviews in 2023 (Red) and 2024 (Amber). Over this period, there have been 6 changes to the Secretary of State for Health and Social Care across 4 distinct UK governments. With each government, there was a renewed commitment to the vision of making health and care data available at scale for research. Additional funding was secured in 2025/6 and, following the Sudlow review, a new government-owned company (GovCo) called the Health Data Research Service will be formed in 2026.

Several interviewees described the 3-year programme as ‘three 1-year funded programmes’, and this lack of financial stability created overhead costs, leading to the recruitment of short-term and/or temporary workers.

The successes of this programme should be attributed to the dedication and commitment of people across the Network, through their collaboration in the communities of practice and their resilience in upholding the vision and scope whilst facing significant and ongoing disruption.

Programme evaluation - delivery of the scope and challenges

The Programme has partially met its objectives. Interviewees acknowledge the original scope was ambitious and broad. It encompassed the establishment of new infrastructure to support a wide range of healthcare research, clinical trials and genomics research, alongside conducting significant public and patient engagement.

Interviewees noted that each research project has unique requirements. There are a broad range of research activities taking place, hosted by the SDEs. These range from discovery science through translational to clinical trials and regulatory approval. Each research project requires a unique combination of data sourced from within the NHS and is sometimes integrated with other data sources. The NHS data needs to be curated and transformed to make it ready for research. We mapped the original scope alongside feedback from stakeholder interviews. We reviewed key documents and have set out the key achievements and identified the challenges and opportunities raised. These are in the tables below.

England-wide ecosystem of NHS-owned and managed infrastructure

The key achievement of the Programme was the creation of an England-wide network of NHS-owned and managed infrastructure. A network of NHS‑owned and managed SDEs is now in place. This includes 11 regional SDEs, complemented by England’s national SDE and the NHS DigiTrials service. Collectively, they form the foundation of an England‑wide network designed to provide secure access to high‑quality, linked datasets for research.

The scope, capacity and capability of an England-wide national health data infrastructure platform have been expanded because of this programme.

A network of sub-national/regional linked NHS health data infrastructure platforms and services has been developed.

The Programme was necessarily ambitious but not set up to recognise the experimental nature of the work that would need to be done initially.

The information governance (IG) and basis for sharing data across NHS trusts and other public bodies is currently negotiated on a case-by-case basis, because each organisation that collects this data for care is a data controller. This takes time to agree and to have the relevant risk assessments considered. There is emerging consensus that further work is needed to address this problem and find a single consistent approach that can support scaling the data available for research. Data quality varies, and preparing data for research requires an in-depth understanding of the data and its collection in the care setting. It is widely recognised that there is a role for regional SDEs as the processes of securing and interpreting data involve a network of human relationships and technical systems.

The regional autonomy has enabled innovation. This has delivered 3 service-delivery patterns and potentially reduced the risk of vendor lock-in, especially within the technical platforms. However, inconsistencies and variations have emerged across service operating models, capabilities, and processes, including IG and data onboarding.

How it's working

The Network is operational but uneven: interviewees have reflected that different SDEs are at varying levels of maturity, with some more advanced in data linkage, service operations, and technical capabilities. 'Federation' across the Network is also taking place. Stakeholders recognise the progress but also acknowledge that the system is still developing towards consistent national coverage.

Data completeness varies - some areas have established pipelines and negotiated data sharing agreements across their network; others remain in development.

'Information governance' is being used as an umbrella term covering legislative, policy, ethical and public‑involvement requirements. The complexity of current data‑controllership arrangements, where thousands of independent controllers hold decision‑making authority, was raised repeatedly.

Some SDEs negotiate approvals on a project‑by‑project basis, while others have established broader agreements covering multiple uses. Both approaches are resource‑intensive and unsustainable at scale. Interviewees also noted that agreements may need to be revisited as operating models evolve, such as during moves toward greater federation.

Opportunities and challenges

Funding uncertainty has repeatedly disrupted delivery, diverting effort toward mitigation rather than strategic development. Stable, predictable funding remains a major opportunity to support long‑term planning and build sustainable capability across the SDE Network.

The term 'federated' data is being used inconsistently - ranging from single sign‑on to code sharing to multi‑site linkage - creating ambiguity about expectations and slowing alignment on technical and governance models.

'Information governance' and data‑sharing arrangements are highly complex and fragmented, requiring agreements with large numbers of independent data controllers. This complexity continues to make delivery at scale slow, repetitive, and difficult to sustain. A more coherent and consistent legal/IG framework would enable faster data flows while maintaining public trust.

Accessing and preparing research‑ready, multi‑modal NHS data remains slow and resource‑intensive due to the scale and diversity of underlying clinical systems. Common engineering approaches and shared extraction patterns could accelerate data curation and improve consistency across regions.

Variation in SDE maturity leads to inconsistent onboarding timelines, interoperability challenges, and uneven researcher experience. Differences in technical platforms, workflows, and accreditation further compound this, limiting the ability to deliver a reliable and a coherent national service.

Strengthening and standardising workflows, data pipelines, accreditation, and IG processes across the Network represents a major opportunity to raise the maturity floor, improve consistency, and create the conditions for innovation at scale.

Increase clinical trials capacity and capability

This objective was set to increase clinical trials capacity and capability by improving the efficiency of the trial setup process. The NHS DigiTrials service has developed a national‑scale capability that has already registered over 1.6 million consenting participants (as of January 2026) willing to participate in clinical trials. This capability has supported the delivery of major priority trials, including high‑profile studies such as RECOVERY and NHS-Galleri, demonstrating that large‑scale, digitally enabled recruitment is possible.

Trials take many years to be set up and to deliver. Anecdotal evidence was presented to illustrate this point: clinical trial recruitment commenced in 2007, and publication concluded in 2024. With long lead-times such as these, it is essential that capacity and capability is embedded within a programme to ensure progress can be made.

However, interviewees noted that the Programme did not sufficiently appreciate the complexity of clinical trials, including regulatory burdens, recruitment, feasibility workflows, and timelines. Some interviewees view the introduction of expertise as far too late, citing June 2024, when two-thirds of the Programme had already passed. Additionally, a trial strategy was produced by February 2025, but the governance structures were not configured to prioritise trials and some view that focus on meeting this objective has stalled. Engagement with key stakeholders should continue; in particular, researchers running clinical trials should be included as domain representatives in relevant programme boards.

How it's working

The Programme is showing strong momentum, with digital recruitment proving to be faster and more efficient than traditional trial recruitment methods.

Integration of the service into broader NHS platforms (such as the NHS App) is expected to further accelerate reach and participation.

Early experience indicates that digitally supported trials can scale rapidly, reduce set‑up barriers, and widen access to research opportunities across England.

Opportunities and challenges

There is significant potential to improve efficiency across the full clinical trial lifecycle by making better use of linked datasets and automated workflows, although these capabilities are not yet fully realised.

Digital recruitment creates opportunities to increase diversity in trial participation, particularly among groups historically under‑represented in research.

The over 1.6 million‑strong volunteer base represents a substantial opportunity to attract additional commercial and academic trials, strengthening the UK’s research offer and long‑term return on investment.

Not all datasets required for efficient feasibility assessments and follow‑up are fully linked or consistently available, limiting the full benefits of data‑enabled trials.

Embedding digital recruitment pathways more deeply into NHS services and patient touchpoints could further accelerate progress but requires operational alignment and sustained investment.

As recruitment activity scales, maintaining public trust remains essential; continued transparency, communication and robust oversight are necessary to sustain confidence in data‑enabled trial methods.

A range of linkage-enriched genomics datasets from linked sources

This objective was to enable researchers to access a range of genomics datasets from linked sources, including globally significant assets held at UK Biobank and Genomics England. 3 SDEs (Thames Valley and Surrey, West Midlands and Wessex) are part of the Central and South Genomics Medicine Service Alliance service footprint. This has enabled the development of a linked genomic and other clinical phenotype dataset, which is built on the data held by Genomics England as an extension to the 100,000 Whole Genome Sequence programme.

The work achieved to date has acted as a catalyst for federated genomic research environments but there is a lack of clarity on data coverage and roadmap.

How it's working

The work has created a strong foundation for federated genomic research, showing that joint efforts between SDEs and national genomic programmes can meaningfully expand research‑ready datasets.

Early integrations demonstrate feasibility and momentum, with SDEs beginning to incorporate phenotype data from multiple care settings and link them securely to genomic records.

The collaboration is viewed as a catalyst for future large‑scale genomic research environments, even though national‑level genomic integration is still emerging.

Opportunities and challenges

A clear strategic roadmap is needed to set out what genomic and phenotype data exist today, how coverage will expand, and how researchers can access these datasets consistently.

Technical harmonisation remains incomplete. Further alignment to standards such as Observational Medical Outcomes Partnership (OMOP) and Global Alliance for Genomics and Health (GA4GH) is required to enable seamless linkage between genomic and clinical data.

Early successes present an opportunity to accelerate adoption, but clearer communication, consistent commercial frameworks, and targeted funding incentives will be required to drive uptake.

Larger, more representative sample sizes are still a challenge; achieving them would significantly improve statistical power for precision medicine, rare disease research, and population‑level studies.

Genomic integration across regions is uneven, with substantial variation in maturity and data availability.

Although OMOP conversions have progressed regionally, harmonisation across the wider network is still at an early stage.

Generate returns to the NHS by attracting life sciences investment and applying commercial principles

This objective focused on generating returns to the NHS by attracting life sciences investment and applying commercial principles. Returns to the NHS are being generated by attracting transactional income from commercial researchers, such as the life sciences industry, and applying commercial principles. Commercial frameworks have been developed and shared amongst the network of SDEs. However, interviewees recognised there is a capability gap, and they are at the early stages of maturity. Interviewees identified that contracting will still need to be done through local host organisations as the data controller and the holders of the governance approval to provide access to data (usually under a Section 251 exemption).

One consistent recommendation for HDRS is to establish a single 'front door' for contracting and commercial approaches. This would be a route to offer customers streamlined access to the etwork of SDE services and to manage the pipeline of requests and the co-ordination of pricing and proposals. This should ensure users are directed to the most appropriate services. If centralised commercial support is considered, it is important to retain connectivity with commercial leads. These teams are embedded in each SDE, have access to that local network along with access to clinical and research expertise that ensures the clinical context for the data provided is not lost. Each SDE needs autonomy to set project prices as the underlying costs vary. This ability would be lost if all the commercial work is done centrally.

The Programme is in the process of updating its approach to tracking benefits, as the Gateway 5 assessment noted; it is not complete, and there is still significant work to do to implement a full tracking approach.

How it's working

The commercial activity is emerging, with SDEs beginning to secure income through paid‑for research collaborations.

The existence of shared frameworks has helped move the system towards greater consistency, though implementation varies across regions.

Commercial engagement is becoming more structured, but the ecosystem remains distributed, which can make it harder for external partners to navigate.

Opportunities and challenges

Balancing public benefit with commercial return continues to present a structural tension, requiring clear principles, transparent governance, and consistent decision‑making across the Network.

Creating a single, coherent 'front door' for commercial engagement remains a significant opportunity. It would simplify navigation for external partners, improve co-ordination of proposals, pricing and contracting, and help direct commercial enquiries to the most appropriate SDE capabilities — strengthening the UK’s overall offer to industry.

A unified commercial approach could also support better forecasting, more consistent revenue tracking, and a fairer distribution of commercial opportunities across regions. Commercial capability and capacity vary widely across the Network, with key‑person dependency identified as a risk in several regions.

Financial returns differ substantially by research area and SDE maturity. This variability makes it difficult to build a stable, long‑term sustainability model for SDE services.

A more holistic commercial model, combining shared processes, a single front door, common data catalogues, and co-ordinated commercial functions, could mitigate these disparities, support cross‑subsidy where appropriate, strengthen capability, and create a clearer pathway toward long‑term sustainability.

Enhance positive patient and public support

There has been significant engagement of patients and the public over the course of the Programme and those interviewed highlight the positive impact that has had on the Programme. The investment in securing support through patient and public involvement and engagement (PPIE) was seen by many as essential to the Programme’s success. The Programme needed broad public support for the concept of sharing real-world health data safely, securely, proportionately, whilst maintaining privacy with researchers. The concept of sharing data is accepted (among those consulted, such as PPIE panel attendees) if it does not leave the NHS. The public's participation in governance committees, such as data access committees, has ensured transparency and accountability in research projects.

The Gateway 5 assessment commends the Programme's engagement with patients and the public as one of its standout achievements. As noted by the Gateway 5 assessment, the Lessons Learned, the Programme’s approach to PPIE should be fully captured and communicated to the HDRS set up team and more widely. It is recognised that this work needs to continue, and patient/public representatives need to be across the governance levels.

How it's working

Engagement has become an embedded and valued part of how the Programme operates, with public representatives already contributing to governance committees and advisory groups. The Programme has built strong foundations for continued involvement, but the maturity and consistency of engagement still vary across regions.

Opportunities and challenges

Ensuring patient and public representatives participate across all levels of governance remains essential for maintaining trust, legitimacy and transparency, but doing so consistently across regions is challenging.

Sustaining meaningful involvement is resource‑intensive, and short‑term funding cycles and operational pressures risk reducing continuity and depth of engagement.

Expectations and practices for PPIE vary across the Network; creating a clearer, more consistent framework, while still allowing for local flexibility, would support a more coherent experience for contributors and users.

Engagement must be continuous rather than episodic; maintaining long‑term involvement is crucial to sustaining public confidence in the responsible use of health and care data.

Achieving diverse and inclusive representation remains a persistent challenge, as reaching under‑represented or seldom‑heard groups requires targeted effort, tailored approaches and sustained investment.

Ensuring diverse representation, reaching groups who are under‑represented or seldom heard, requires ongoing effort and investment.

Last edited: 8 May 2026 11:47 am

Operational achievements

Context alongside Gateway 5 assessment

Programme evaluation - delivery of the scope and challenges

England-wide ecosystem of NHS-owned and managed infrastructure

Increase clinical trials capacity and capability

A range of linkage-enriched genomics datasets from linked sources

Generate returns to the NHS by attracting life sciences investment and applying commercial principles

Enhance positive patient and public support

Chapters