The time is right for a grand resurgence of commercial clinical trials in the UK

In the dark days of 2020, amid the global race for a COVID-19 vaccine, the UK showcased its world-class expertise in medical research. The swift development of the Oxford-AstraZeneca vaccine, propelled by funding from the UK Vaccine Taskforce, resources from the NHS and delivery hubs from the National Institute for Health and Care Research (NIHR), was a testament to our ability to deliver major trials of new treatments.

However, this rapid, efficient, successful partnership between the public and private sectors is far from the norm. Unfortunately, delays and bureaucratic hurdles have steadily eroded the pharmaceutical industry’s enthusiasm for recruiting UK patients for large-scale clinical trials.

The 2023 report by Lord O’Shaughnessy on commercial clinical trials in the UK found that, “Countries like Spain and Australia have stolen a march on us, with companies choosing to initiate more trials in each of these countries compared to the UK, in what is an increasingly competitive global marketplace.”

The UK’s diverse population and skilled medical researchers should be a magnet for international pharmaceutical companies seeking clinical trial sites. Having these studies on our shores keeps our clinicians at the cutting edge of medical science and offers patients the unique chance to access new medications while receiving regular health assessments.

Large-scale commercial trials not only advance medical science, but also bring significant investment to the country. Each patient recruited is worth about £9,000 income, plus the almost £6,000 savings on treatment costs that the NHS would otherwise bear. Research for the O’Shaughnessy report found that the fall in patients recruited to commercial research in the NHS from 2018 to 2023 would have produced £570 million in income and saved £360 million of costs.¹ It is little wonder that there is fierce international competition for hosting these valuable trials.

Lord O’Shaughnessy proposed a target of quadrupling participants in commercial clinical trials by 2027. As ambitious as this sounds, he has correctly identified an enormous opportunity for the UK to reclaim its position as a world leader in these vital studies, and quickly.

Improvement in national regulatory approvals

One major hurdle has been the protracted delays at the Medicines and Healthcare products Regulatory Agency (MHRA) in approving clinical trial applications. The O’Shaughnessy report found that the UK took 100 days longer on average than the US to set up a clinical trial in 2020.1 One pharmaceutical company even ranked the UK as the second slowest in Europe.

Following the report, the Government injected additional funding into the MHRA last year to boost its workforce and streamline its processes. That effort has successfully cleared a major backlog of clinical trial applications and significantly reduced approval times.

This presents a major opportunity for the UK because the European Medicines Agency has introduced new regulations that demand that all EU countries have to agree on the same application to run a clinical trial before it can be approved. This regulatory tightening puts the UK at an advantage, as our national approvals have sped up while the EU has slowed down.

NHS Trusts and their local governance

The pressures within the NHS hardly require emphasising. The urgent need to clear waiting lists means that staff are not available to do research, and clinical trials are not prioritised by senior managers.

Industry trial protocols are often significantly weightier than academic ones, due to the need for international standardisation with much greater costs. This scale and complexity make it particularly challenging for pharma and biotech companies to navigate the NHS. Although the NHS recruited over a million patients to clinical trials in 2021/22, only 2% of these were for commercial trials.¹

The UK’s strong academic research portfolio and the prestige of its universities are cornerstones of its scientific reputation. The innovation and expertise fostered within our life sciences ecosystem create numerous opportunities for cross-sector partnerships. However, the irony is that the very strength and breadth of academic research pressurises capacity within the NHS for commercial trials. For the whole duration of my 30-year career in clinical operations in major pharma, bringing commercial research into the UK has never been straightforward.

While the NIHR aspires to present itself as a ‘one-stop shop’ for industry and academics to do research within the NHS, the reality is more complex. While welcome advances in standardisation have been achieved through the HRA and National Contract Value Review process to align ethics approvals and budget expectations, the NHS consists of more than 200 Trusts, each a separate legal entity, which becomes very clear when trying to get a proposal or contract through each Trust’s governance processes. Each Trust must ultimately take responsibility for itself.

CROs and pharma companies do persist to set up recruitment sites in the UK, even though the delays in contracting mean they often rely on other countries to make up the numbers and the UK cannot maximise our recruitment potential.

Building commercial research capacity

The recent announcement of the Voluntary Scheme for branded Medicine Pricing, Access and Growth (VPAG), an arrangement arrived at between Government, NHSE, and ABPI is to be welcomed, bringing much needed investment of £400 million, 75% of which will be directed towards enabling developments and capacity enhancements for 18 ‘new’ commercial research delivery centres (CDRCs).² While the O’Shaughnessy report suggested developments were needed ‘at pace and scale’, this likely addresses the latter but not the former? There, of course, is a lengthy bidding, selection, and decision process, staff assignment, and training - with capacity change unlikely realised until late 2025, if then.

Tapping into ready-made research recruitment capacity

By their nature, large-scale commercial clinical trials tend to be complex as a result of meeting the requirements of regulators and maximising the data gathered. This can involve ticking a lot of boxes and using multiple computer systems for data entry. For busy NHS staff juggling several competing priorities, who may only recruit just a handful of patients at their site, it can be an unwelcome burden to familiarise themselves with the processes and avoid making mistakes. By contrast, dedicated staff at SMOs (Site Management Organisations), who are seeing dozens of patients per trial, can accomplish this essential record-keeping more efficiently.

Rather than expecting the NHS Trusts alone to suddenly develop the resources and expertise to meet the demand, we already have ready-made clinical trial capacity in the private sector. SMOs are specialists in recruiting trial participants, offering a simpler and faster route for conducting successful commercial trials. Isn’t the goal to better understand how the public-private partnership could be better harnessed?

At least six SMOs operate in the UK, recruiting thousands of patients annually across about 50 sites. With ample capacity to expand, they could be the solution to clearing the logjam that deters pharmaceutical companies from the UK.

SMOs can set up and start recruiting in just a few weeks, compared to an average of 28 weeks in the NHS. Long established experience with social media, targeted advertising, and vast pre-qualified patient databases rapidly identify people willing to take part. For trials with a short window for recruitment, such as testing vaccines, this targeted approach is very effective.

This also means that each SMO trial site can recruit dozens, if not hundreds, of subjects. By comparison, it is not unusual for an NHS site to fail to recruit a single patient. When each site costs tens of thousands of pounds to find, train, and open, this inefficiency can be extremely costly and wasteful for commercial sponsors.

The SMO model is a British innovation. In the 1990s, Ian Smith, a GP in Chorley in Lancashire, realised that mixing day-to-day clinical practice with running clinical trials was cumbersome for everyone involved, including patients. By establishing separate clinics for trials, Smith soon found numerous advantages. For instance, the trial recruits could enjoy a comfortable, calm space away from patients crowded into the GP waiting room. It might sound insignificant, but these minor conveniences – like quickly reimbursing travel costs – can have a major effect on retaining patients taking part in long studies.

Hiding in plain sight

The Labour manifesto pledged to “maximise our potential to lead the world in clinical trials”. With our regulatory advantage over Europe and unused research capacity, the time is right to reclaim the UK’s position as a global hub for cutting-edge clinical care.

The Government has recently announced funding for new Commercial Research Delivery Centres to build up the NIHR’s infrastructure to support industry trials. This is a welcome development, but in the time it takes to select, fund, and open these centres, we will continue to miss out on valuable opportunities.

Unfortunately, the NHS either isn’t aware of or doesn’t recognise the value that SMOs can contribute to health research in this country. They can provide a ready-made platform to support the NHS in achieving its research ambitions, relieving much of the burden without the distraction of routine care.

The need for greater collaboration between the NHS and the private sector is becoming increasingly recognised. Dame Kate Bingham, former head of the Vaccine Taskforce, recently spoke about the need to recruit patients for Alzheimer’s trials, saying that the government “has to embrace working with industry, rather than thinking they’re out to nick your wallet.”

Although SMOs received little mention in his 2023 report, Lord O’Shaughnessy has since highlighted³ the value of the NHS building more dedicated research capacity through public-private partnerships with SMOs and others.

SMOs appear to be hiding in plain sight as an option to truly expand our commercial clinical trial delivery, particularly in late-stage drug development.

Now that regulatory approvals are back on track, and the EU has slowed down, we cannot afford for growth in commercial clinical trials to be tardy, and must fully embrace the spectrum of organisations who can transform this. A clear commitment and openness to efficiently delivering life-saving treatments will see commercial trials return to our shores in vastly greater numbers and bring much-needed investment and life- change. Collectively, we should recognise the immediate capacity and expertise in our SMOs, who are ready and waiting.

About the author

Hilary Coles, PhD, has over 30 years of experience in the pharmaceutical industry, both within major global pharma and as a supplier to the UK pharma industry. Coles has a broad experience extending to marketing and resourcing, but with the far majority being in clinical operations. She was R&D director for Janssen’s global clinical operations in the UK between 2010 and 2016, becoming their strategic account lead for research in the UK 2016-2022. This involved negotiating strategic partnerships with major UK hospital trusts and the NIHR, as well as commercial research networks while representing all therapeutic areas of the company. Coles headed the R&D team in preparing Janssen’s clinical operations for Brexit and was joint industry chair at the ABPI Clinical Research Working Group between 2019 and 2021. Retiring from mainstream pharma in 2022, Coles has continued a passionate interest in ensuring clinical research in the UK re-emerges as a ‘gold star’ partner for industry, making full use of the depth and breadth of expertise in the UK, both academic and commercial.