The big reset

Rebuilding the clinical trials landscape in the UK

For years, regulatory complexities and administrative hurdles delayed the start of clinical trials in the UK. However, recent overhauls have marked an important step towards change.

In 2023, the national contract value review (NCVR) introduced a standardised approach to costing industry research, replacing the lengthy process of individual NHS negotiations with individual commercial sponsors to agree bespoke contract values. This streamlined method has cut industry clinical trial set-up times by 35%.

However, this was only part of the challenge. Industry partners also faced lengthy delays in trial approvals. To address this, changes to clinical trials regulation were implemented earlier this year, introducing a single Combined Review by the MHRA and NHS RECs.

Recent data shows Combined Review approval times are now 60 days or less for all trials – a major step forward towards the Government’s 10-Year Health Plan target of reducing trial set-up from 250 to 150 days by March 2026.

However, countries like Spain, where clinical trials start in around 100 days, still outpace the UK, highlighting the need for continued progress if this is to be seen as a true strength for the UK.

An issue that compounds longer trial start-up times is patient recruitment. In 2024, between 20 and 30% of industry clinical trials in the UK did not recruit the agreed participant numbers within the specified time frame.

The UK Government’s 10 Year Health Plan has also moved to address this. Patients can find and enrol in trials directly via the NHS App. In time, the aim is for the app to match patients with studies based on their own health data, sending notifications to your phone about relevant trials.

The Be Part of Research campaign is supporting this approach, encouraging people to sign up to be involved in research with a particular focus on underrepresented groups. So far, more than 1 million people have registered to take part, and the government has set a new target of 2 million sign-ups by March 2026.

This is an area where the UK is making changes but the impact of this is yet to be seen. The utilisation of the NHS App for trial recruitment shows promise, however the extent to which a public health campaign like Be Part of Research will engage historically under-represented groups is difficult to anticipate.

Trust in the government is low among these groups, and this approach feels like more of the same rather than a meaningful change in strategy.

It would be interesting to see the government collaborate more closely with trusted local groups, charities, faith organisations and patient advocacy groups to enhance participation in research.

A final area to consider is the cost of clinical trials in the UK. In comparison to the US, UK costs for clinical trials are fairly low – particularly regulatory, site and indemnity fees – and they are generally comparable to the rest of Western Europe, despite being higher than other regions.

The UK’s scientific infrastructure and expertise to some extent justifies the investment for industry here.

However, the clinical backlog caused by COVID-19 is still haunting the UK, with NHS resources focused on routine care and addressing waiting lists. This has reduced personnel and budgets available for research. As a result, trial sponsors may need to pay premium rates for staff or cover service support costs to backfill roles.

Elsewhere, ABPI research has highlighted the slow uptake of innovative treatments in the NHS. For every 100 patients receiving a new medicine in its first year of launch in the EU – including France and Germany – just 21 patients in the UK get access.

The reduced likelihood that patients will be able to access new innovative medicines post-trial is an added financial factor discouraging companies from placing clinical trials in the UK.

Unsurprisingly, countries like India and China have pulled ahead of the UK, but many less obvious markets such as Poland, Bulgaria and Hungary have also seen huge increases in the number of clinical trials taking place.

Advantages of clinical trials in Eastern European countries have included the volume of well-trained medical staff and low costs. Elsewhere, countries such as Australia offer tax incentives for companies to conduct R&D efforts.

The UK Government has looked to close the gap, with the Life Sciences Sector Plan promising significant investment to support clinical trials and reduce industry costs.

 This includes:

• • Over £2 billion in government funding to strengthen clinical research capacity – supporting new trial centres and modernising existing facilities
• • The NHS ‘passport’ to help fast-track proven digital tools and AI diagnostics for use in managing clinical trials.

The time for cautious optimism has passed. If the UK is to reclaim its place as a global leader in clinical research, we need to move decisively – from policy to practice, from ambition to action.

It’s not just a matter of competitiveness; it’s a matter of patient access, scientific progress and national health resilience.

The UK has the tools, the talent and the infrastructure. What’s needed now is unwavering commitment and collaborative execution across government, industry and the NHS. Let’s not wait to be overtaken – let’s lead.