Clinical trials in the UK: Landscape, reform and what’s next

The UK has been a significant location for pharmaceutical clinical trials for decades but the country lost ground through the 2010s and early 2020s. The gap between what the NHS could theoretically offer and what industry actually experienced became harder to ignore. Speed, predictability and data access all became sticking points and sponsors began directing more commercial clinical trial activity elsewhere.

That decline prompted a hard look at the system, a government-commissioned review, and a reform agenda that is now starting to show results. Where the UK goes from here depends on whether the momentum of the last two years can be sustained and sharpened.

What clinical trials are, and why they matter

A clinical trial is a study in which a medicine, device, or intervention is tested in human participants under controlled conditions. Trials run in phases, from early safety testing in small groups through to large-scale studies comparing outcomes across thousands of patients. Before any medicine reaches the clinic, it must have passed through this process. Trials are also how existing treatments get refined: lower doses, new indications, better-tolerated formulations.

The commercial calculus

For pharmaceutical companies, clinical trial site selection is as much a commercial decision as a scientific one. The factors that drive site allocation include:

• Speed to first patient

• Screening failure rates

• Site productivity and recruitment yield

• Data quality and regulatory predictability

• Patient demographics and diversity

A country that offers good academic centres but unpredictable performance, or rich health data that cannot be accessed, does not compete effectively regardless of its underlying assets.

Why it matters beyond pharma

Patients and health systems benefit directly when trials are conducted in their country. Participants often access treatments years before regulatory approval. NHS trusts that host trials generate income and develop clinical expertise. The wider economy benefits too:

• The pharmaceutical industry in the UK supports around 73,000 jobs

• It contributes £20 billion in gross value added (GVA) annually

• A Frontier Economics analysis commissioned by the Association of the British Pharmaceutical Industry (ABPI) estimated that returning UK commercial trial activity to 2017 levels would deliver a further £500 million annually to the NHS, and could bring thousands of people off welfare through improved health outcomes

The decline and what drove it

Between 2017 and the early 2020s, the UK’s share of commercial interventional trials fell. The reasons were well documented.

Performance data that made for difficult reading

• Average site setup times ran to over 200 days, with variability that made planning unreliable

• In some therapeutic areas, screening failure rates reached 90%, with global sites filled before UK patients were enrolled

• 1 in 10 sites in a given trial recruited no patients at all

• Time from trial approval to first patient ran 49% below the 90-day target

A structural problem

The issue was not a lack of skill or credibility. Research was not consistently prioritised in NHS institutions under acute operational pressure. Performance data was fragmented and not publicly tracked in a way that created accountability. There was no single operating model, so variation between trusts was high and hard to reduce. The health data opportunity, in principle one of the UK’s most distinctive assets, was being systematically underused.

The O’Shaughnessy review and early results

In 2023, the O’Shaughnessy review of commercial clinical trials in the UK identified these problems and set out a framework for action. The policy response brought together investment and structural change across the system.

What changed

• Industry investment secured through the VPAG pricing scheme, funding dedicated commercial research capability across English NHS trusts

• New primary care research sites established as part of the commercial trial infrastructure

• An industry hub created within the National Institute for Health and Care Research (NIHR)

• Clinical trial delivery commitments in both major party manifestos at the 2024 general election, the first time this had appeared as a political priority

Where the numbers have moved

MHRA clinical trial approval times have shown the most rapid and visible change. Median approval times fell from 273 days to 122 days between 2022 and 2025, transforming the UK’s regulatory position for international sponsors. Commercial interventional trial initiations rose by 37% in 2024 to 2025 compared with the previous year.

A real-time performance reporting system is due to come on stream in 2026, creating public accountability for site-level trial delivery across the NHS for the first time.

Where gaps remain

These are real gains, but participation rates, the number of patients actually enrolled across commercial trials, remain the lagging indicator. The most recent data showed a small fall. Variability around the median setup time is still too high. A 30-day target for time to first patient is still being missed by close to half of the trials. The system is improving, but it has not yet translated into the patient participation numbers that would confirm the UK is fully competitive again.

NHS health data and clinical trials: promise and gap

The UK’s greatest structural advantage in clinical trials is the NHS and the health data it generates. Every patient’s journey through primary and secondary care, from GP appointment to hospital admission, from prescription to diagnostic result, creates a longitudinal record. No other healthcare system of comparable size generates this kind of integrated data within a single national framework.

What data-enabled trials can do

NHS health data for clinical trials addresses the four metrics that most influence pharma clinical trial site selection decisions:

• Reduce screening failures by identifying eligible patients from coded records before they enter a trial

• Reduce non-recruiting sites by directing recruitment to where relevant patients are

• Reduce staff burden by automating data collection from existing records, removing the need for manual case report forms

• Reduce time to first patient by shortening the feasibility and set-up phase

What’s already possible

These are not hypothetical benefits. Networks running data-enabled trials in primary care are already accessing and inviting 13 million patients from their primary care records. A patient can be identified as eligible and contacted about a trial within 24 hours of a coded GP appointment. Trial staff in these networks complete a six-minute Good Clinical Practice (GCP) approval process. Participants can join a trial by text message.

The gap with current practice

Only a small proportion of commercial clinical trials running in the UK are routinely using NHS health records as part of their data package. The infrastructure exists, the data exists, and the clinical networks to access it exist, but they are not yet integrated into the standard operating model a sponsor or contract research organisation (CRO) would encounter. The feedback from sponsor level is consistent: the UK talks about its data, but accessing it in practice remains slow, fragmented and unpredictable.

Health Data Research Service

Health Data Research Service (HDRS) has been established to address this, funded with £600 million from the UK government and the Wellcome Trust. It is designed to be the single front door for health and care data in clinical research, covering research, clinical trial support and post-market surveillance. Its creation as a delivery service, rather than another advisory body, reflects a deliberate decision to build something that researchers and sponsors can actually use.

The challenge it inherits is structural: UK health data is fragmented across institutions, governance has accumulated layers of process, and in some cases it is faster to set up a clinical trial than to access a patient dataset for feasibility analysis. Addressing this requires minimum data standards as a condition of NIHR funding, streamlined governance, and sustained political commitment alongside the technical build.

The case for non-commercial trials

The commercial trial agenda has driven most of the recent policy attention, but non-commercial trials, those funded by the public sector and medical research charities, are an equally important part of the ecosystem.

Research commissioned by the Association of Medical Research Charities (AMRC) and carried out by Frontier Economics found that:

• Non-commercial research generates £72 billion in economic return over 10 years, comparable to the £7 billion per year from commercial trials

• It covers ground that commercial sponsors do not: care pathway optimisation, prevention, rare diseases, drug repurposing and reducing side effects

• Collaborative research funded by both commercial and non-commercial sources is cited twice as often in the scientific literature as single-source studies

The infrastructure that enables commercial trials to run in the NHS, the workforce, governance frameworks and site expertise, is largely funded through non-commercial research budgets. Treating commercial trial improvement as the only metric understates what the UK stands to gain and lose.

UK clinical trials competitiveness: the global context

The UK is not reforming in a stable competitive environment.

European competition

Spain, and Catalonia in particular, has built a strong position through standardised operating models, a single regional data infrastructure and consistent site performance. Denmark operates with a national framework that has few parallels in scale-adjusted productivity. These countries are not larger or more scientifically advanced. They are more consistent, and consistency is what sponsors price into their pharma clinical trial site selection decisions.

UK vs China clinical trials

China presents a challenge in scale and pace. Life sciences investment there increased 400-fold over the last decade, with 40% shorter clinical trial durations and 35% lower direct patient costs for Phase III trials, as presented by ZS Consultancy at the recent Reuters conference. From April 2025, trials initiated in China are required to adhere to global GCP standards, removing the historical argument that Chinese data quality was incomparable. Volume, cost base and regulatory equivalence now combine to make China a direct competitor for global trial allocation across therapeutic areas, not only oncology.

South America and other Asian markets are also growing. The UK is improving against a baseline that was poor, while the overall competitive field expands.

Reasons to be positive about UK clinical trials

Against this backdrop, there are genuine grounds for confidence, provided the reform agenda continues at pace.

Regulatory performance. MHRA clinical trial approval times have transformed, falling from 273 to 122 days. This is a structural change, not a one-off, and it creates a foundation that other parts of the system can build on.

Population diversity. In a single country, sponsors can find the genetic variation, ethnic diversity and disease prevalence across populations that other European markets cannot offer at scale. As trial designs increasingly require representative participant populations to meet regulatory expectations, this becomes a genuine differentiator.

Primary and secondary care data linkage. Countries with strong secondary care data are common in Europe. Countries where primary care data links to secondary care, capturing the full patient journey including GP consultations, prescriptions and long-term condition management, are not. If HDRS delivers on its mandate, the UK can offer something that Spain, Germany or the Netherlands cannot replicate.

Primary care research infrastructure. Around 25% of GP practices currently participate in NIHR portfolio studies, against 100% of acute NHS trusts and 94% of mental health and ambulance trusts. Closing that gap represents a material increase in the accessible trial population, and the infrastructure to do so is actively being built.

AI and data. AI has a clear near-term role in making the NHS health data asset work harder for clinical trials: identifying eligible patients from coded records, reducing screening failures through pre-trial feasibility analysis, and automating data collection. Some of these applications are already running at site level. Longer term, multimodal datasets linking genomics, imaging and clinical records open the possibility of stratified recruitment and synthetic control arms that would transform the economics of trial design.

What the UK needs to do next

Progress is being made, but the conditions for sustained UK clinical trials competitiveness are not yet secured.

Make data access the default, not the exception

HDRS has the mandate and the funding. It needs:

• Clear minimum data standards as a condition of NIHR funding

• A streamlined governance model that removes duplication without removing accountability

• Reusable protocol archetypes that stop sponsors and sites reinventing feasibility infrastructure for every trial

• A single coordinated system for pseudonymised search, feeding down to data controller level for patient identification and recruitment

Align consent frameworks with public expectations

Surveys consistently show that the public expects NHS data to be used for research. Most people assume it already is. A default of consent to contact for NHS patients regarding research would align the legal framework with what patients themselves consider reasonable. This could be achieved through primary or secondary legislation, or by piloting the approach within the 10-year health plan’s innovation zones before national rollout.

Move from measuring performance to managing it

The new performance reporting system will provide visibility. Accountability means making NIHR funding contingent on meeting minimum standards, not simply on participating. High-performing sites, whether NHS trusts, primary care networks or private sector research organisations, should be identifiable and scalable. The private sector trial site market is already delivering significant randomisations outside the NHS but is currently uncounted in national statistics; bringing it into the performance framework would give a more accurate picture of UK capacity.

Give sponsors the metrics that change decisions

Improvements in median setup time are necessary but not sufficient. The metrics that change allocation decisions at sponsor level are site-level: patients recruited per site, screening failure rates, and time to first patient. These metrics are well understood across the system. The challenge is producing them consistently and making them available to sponsors.  

The UK clinical trials reform agenda is three years old and producing early results. MHRA clinical trial approval times have transformed. Trial initiations are up. Primary care is being drawn in. HDRS has been created and is setting its direction. The policy environment is more supportive than at any point in the last decade.

The question is not whether the UK has the assets to lead in Europe. The question is whether the system can be standardised, integrated and accountable enough to translate those assets into the consistency that sponsors require. Denmark and Catalonia are the comparators to watch in assessing UK clinical trials competitiveness: not because they are larger or scientifically stronger, but because they built the operating model that allows their assets to be used predictably at scale.

The UK is closer to that model than it was two years ago. The decisions being made now about HDRS architecture, data governance, consent frameworks and site accountability will determine whether the current momentum compounds or stalls.

CHASE is the UK's leading independent partner for people-centred solutions in life sciences and the NHS. We support clinical trial delivery directly, providing the clinical staff, including safety sub-investigators, research nurses and project managers and trial facilitators, that studies depend on. If you want to discuss how the clinical trials landscape affects your organisation's strategy, or how we can help you resource a trial, get in touch with the CHASE team.