Turning the NHS into a world-leading R&D platform

At its best, cutting-edge science has a bewitching, almost magical, quality. 

The UK is blessed with a highly creative academic sector and four of the world’s top ten leading research universities. Matched with an entrepreneurial economic culture that is second only to the US, this makes our science sector the envy of the world. On a personal level, one of the most enjoyable parts of working in this sector is spending time with the researchers and clinicians whose discoveries will improve the lives of so many people.

A track record of excellence in early phase clinical trials

Inventions and discoveries alone don’t save lives, however. For a therapy, device, diagnostic, or digital tool to reach patients it requires a long, laborious process of translating insights into products and then testing their safety and efficacy through clinical research. The UK has a magnificent track record in in this field, both in our historic achievements and recent successes in COVID-19 vaccine and therapeutic trials. By international standards, we continue to perform strongly in early phase, academically-driven clinical trials, and the vast majority of patients recruited to clinical studies in the NIHR Clinical Research Network portfolio are recruited to trials with a non-commercial sponsor.

But despite our many strengths in R&D, the UK has been falling behind in the delivery of commercial clinical trials. Numbers enrolled on later phase, commercially-led studies dropped by 44% between 2017/18 and 2021/22, according to ABPI research. Our relative ranking against other countries dropped too, from 4th to 10th best in the world, in the same timeframe. Countries like Spain, Australia and Poland have stolen a march on us.

This is a bad outcome all round. Less trial activity means lower patient access to effective treatments and a significant financial opportunity cost for the NHS. It reduces the desirability of the UK as a destination for life science investment, impedes health innovation, and has a negative impact on health outcomes.

A review that engages with all stakeholders to develop solutions

The independent review I’ve been asked to lead for the Government will put forward ideas on how we can both arrest our decline and transform the commercial clinical trials environment. This is not a zero-sum game, and any proposals that benefit commercially-led research should also benefit academic studies, too. Our success in early-stage research is a strength to be celebrated and nothing I recommend should reduce UK competitiveness here.

Supported by the Office for Life Sciences, I’m engaging with industry, the NHS, patient groups, and regulators to bottom out the problems and develop solutions. The review will cover every step in the process of clinical trials, from workforce issues and patient engagement, through to set up times, approvals processes, data access, and how we incentivise each part of the system to undertake more research.

Paramount from an industry perspective will be sorting out the site identification, approval, set up, and recruitment process. The UK badly lags behind best-in-class countries, taking up to 50% longer to recruit for trials and often under-delivering on patient numbers. ‘Unpredictable’ and ‘unreliable’ are words that commercial R&D leads have mentioned, making it hard for them to make the case for a strong UK presence in any given trial.

I’m confident there is the potential to make it significantly easier to start and run trials without sacrificing safety by removing much of the bureaucratic undergrowth, but it will also involve industry playing its part and not adding to the unreasonable compliance demands we currently make of clinical researchers.

The UK as a science superpower, with the NHS at its heart

There are many areas of outstanding practice in the UK, where what we do is genuinely world-leading. Born out the experience of running the RECOVERY Covid-19 trial, Protas provides a platform for large population health studies that is radically more cost-effective than the traditional trial model. And Greater Manchester has bucked the UK’s trend and increased its commercial trials activity in recent years.

The NHS and GRAIL Galleri partnership recruited 140,000 patients in a year to trial a new multi-cancer diagnostic. The Moderna and BioNtech deals will create a new platform for mRNA vaccine research. And the Accelerating Clinical Trials initiative led by Professor Charlie Craddock at the University of Warwick is using research charity funding to create an outstanding service for clinical trials in blood-based cancers. Part of the review’s job will be to outline how – through comprehensive policy change – these examples of exceptional practice can become the norm.

But perhaps one change more than any is needed, and that is in the attitude that everyone involved in health and care – public, patients, clinicians, managers, and politicians – has towards research. If the UK is truly going to be science superpower, we have to use every asset at our disposal and none is more significant than the NHS.

There is every reason to aim this high. We have the workforce, the scale, the data, the science base, the research charities, and many other strengths. A statement from leaders across the UK that it is our ambition for the NHS to become the world’s leading platform for health and life sciences research, followed by a comprehensive plan of action, would be a powerful signal of intent.

About the author
Lord James O’Shaughnessy is Senior Partner at the health and life sciences consultancy Newmarket Strategy. He has operated at the highest levels of government, including as a Minister at the Department for Health & Social Care, as Director of the No.10 Policy Unit, and as an advisor to DHSC Ministers during the COVID-19 crisis.

As Minister his responsibilities included implementing the Life Science Industrial Strategy, delivering a new pricing scheme with the pharmaceutical industry, chairing the National Genomics Board, and driving the digital transformation of the NHS. He was also responsible for preparing the health and social care sectors for Brexit and helping to design the post-Brexit regulatory regime.

O’Shaughnessy is a Visiting Professor at the Institute of Global Health Innovation at Imperial College London, a non-executive director of the Albion Development VCT plc, and a Trustee at Health Data Research UK. He is on a leave of absence from the House of Lords. At the start of 2023, O’Shaughnessy was asked by the Government to lead an independent review of commercial clinical trials, which will report in Spring.