Three steps to boost patient access to clinical trials in the UK

Ahead of International Clinical Trials Day and the publication of Lord O’Shaughnessy’s independent review into industry clinical research in the UK, Oliver Buckley-Mellor, ABPI Research Policy Manager, sets out the key actions needed to get clinical trials back to full strength.

Clinical trials are at the heart of scientific research and the development of new medicines and vaccines, delivering benefits for patients, the NHS, and the economy.

Yet, between 2017 and 2021, the number of people recruited to industry trials decreased by 44%, and the UK’s global ranking for phase III trials – those with new medicines closest to market – plummeted from 4th to 10th.

Fixing this matters. People treated in research-active hospitals get better care, better outcomes, and have lower mortality rates.

And on top of that, research generates valuable income for the NHS. For every patient recruited onto an industry clinical trial between 2016 and 2018, the NHS in England received more than £10,000 in revenue and cost savings from life sciences companies.

The economic benefits are significant too. Increased investment in research and development could generate an additional £68 billion of GDP over the next 30 years.

This is why the Government commissioned former innovation minister Lord O’Shaughnessy to lead an independent review that will offer recommendations to reverse the decline of industry clinical research and help it unlock growth and investment.

To address the immediate obstacles to setting up and delivering clinical trials, three steps must be taken to make sure the UK has an internationally competitive and effective clinical trials ecosystem.

1. Streamline research approvals and set-up

Before it starts, every clinical trial must be approved by regulators to make sure it meets rigorous scientific standards and safeguards the rights, safety and dignity of research participants. Data from the Office for Life Sciences shows the UK lags behind other countries when approving and setting up clinical trials, which limits opportunities for patients to participate in research and reduces the UK's competitiveness. For instance, Spain is now the leading country in Europe for late-phase industry research, completing these processes 50 days faster than the UK, which takes a median of 247 days.

The UK wants to catch up, and the MHRA and HRA have introduced a 60-day target for combined regulatory and ethics review, which has been welcomed by industry. However, sponsors of clinical trials have recently been experiencing delays in meeting this target. 

To accompany this, the UK must build on its offer of early scientific and regulatory advice and reform its clinical trial regulation, to ensure sponsors see the UK as a pragmatic and enabling environment to develop new medicines and vaccines, and a test-bed for innovative clinical trial design and delivery approaches.

If the UK is to fully deliver on its ambitions to be a life sciences superpower, then regulators must be sufficiently resourced to clear the current backlogs and co-develop new regulatory guidance to help sponsors navigate the new clinical trial legislation.

Additionally, the administrative processes of costing and contracting a clinical trial should be in-line with that 60-day period so studies can begin recruiting patients sooner. The National Contract Value Review programme is beginning to show progress in this regard, and we recommend the Government accelerates its implementation.

2. Expand capacity to deliver trials on time and target

Industry trials often experience difficulties recruiting participants to time and target, which is a multifaceted challenge compounded by limited research capacity. There aren’t enough people in the NHS who are involved in clinical research and, as a result, around half of industry trials fail to meet their recruitment targets.

This has led to around 22,000 fewer people participating in industry clinical research in 2021/22 compared with recruitment in 2017/18, with industry research’s share of overall trial recruitment declining from 5.9% to 2.2% in that period. This matters because for some people, particularly those with a rare disease, clinical trials can be the only way to get treatment for their condition.

The UK remains the European leader in early-phase (phase I) industry trials, and sustained investment in dedicated research infrastructure, like the NIHR-funded Biomedical Research Centres and Clinical Research Facilities, is a major driver of this success. Taking the learnings from this and boosting investment in late-phase trial infrastructure would directly improve thousands of patients’ lives and help reverse the decline in Phase III trial activity in the UK, which has dropped by 48% since 2017.

Health data is hugely helpful for finding the right patients for the right clinical trials. Instead of solely relying on clinicians to refer patients to a trial, which often creates a postcode lottery for who gets to access research, researchers can use health data to search for eligible patients in a larger population, enabling recruitment to be more efficient and inclusive. Therefore, the Government should develop the UK’s capability to use real-world data (RWD) to improve the speed, diversity, and efficiency of recruitment into clinical trials. This RWD recruitment service should also be accompanied by efforts to raise awareness of research and enable patients to proactively pursue opportunities to participate in a trial, which is vital to reducing inequalities in access to research.

3. Report on clinical research performance

Finally, the UK lacks a nationwide clinical research dashboard to describe its performance in clinical research to global sponsors looking to assess how the UK compares domestically and internationally. A leading example is Spain's, where industry, academia, healthcare systems and government work together to collate metrics and describe in a single narrative how the country performs and what the benefits of research are. Having a transparent UK dashboard, which includes metrics on volume, speed, quality, impact, and innovation, would help maintain accountability for performance, identify where bottlenecks are, and showcase what’s working well.

Next steps

Lord O’Shaughnessy’s independent review of clinical trials and the Government’s response are expected later this month, and like many others, we have contributed our views to inform its recommendations.

If we can make the process of setting up and recruiting to industry clinical trials in the UK quicker and easier, it would have huge benefits for patients, the NHS, and the economy.

We look forward to seeing the review’s findings, and we will continue to work with government, the NHS and the research community to improve the clinical research ecosystem and get industry clinical trials back to full strength in the UK.