The Government has appointed former Minister for Innovation at the Department of Health and Social Care (DHSC), Lord James O’Shaughnessy to conduct an independent review into the UK commercial clinical trials landscape.
Alongside his new role, Lord O’Shaughnessy is Board Member of Health Data Research UK (HDR UK), Senior Partner at consultancy firm Newmarket Strategy and Co-Chair’s independent policy institute Curia’s NHS Innovation and Life Sciences Commission.
The Government has said the Review will offer recommendations on how commercial clinical trials can help the life sciences sector unlock UK growth and investment opportunities. The Review will also advise on how to resolve key challenges in conducting commercial clinical trials in the UK.
The Review will build on the Government’s 10-year vision for clinical trials, Saving and Improving Lives: The Future of UK Clinical Research Delivery, published in March 2021.
The Review will take account of the work of the Recovery Resilience and Growth (UK RRG) programme, which brings together partners across the health system and industry to help deliver this 10-year vision.
Curia’s NHS Innovation and Life Sciences clinical research inquiry
In 2022, the NHS Innovation and Life Sciences Commission held a rich discussion on the needed clinical research infrastructure. In 2023, the Commission will review last year’s work and make further recommendations following a series of ‘sprints’ organised around the UK, placing the patient at the heart of the Commission’s modelling work.
Co-chaired by Lord O’Shaughnessy and Professor Mike Bewick, co-chairs of the Commission, the inquiry session focussed on the critical role of clinical research to improve patient outcomes.
In this inquiry, the Commissioners and expert speakers discussed implementable solutions to improve health outcomes and reduce health inequalities.
Joined by eight fantastic panellists, including Director of Research and Engagement at NHS England, Lindsey Hughes, Professor of Medicine & Epidemiology at University of Oxford, Sir Martin Landray and Director of Research Policy at the Association of British Pharmaceutical Industry (ABPI), Dr Jennifer Harris, Lord O’Shaughnessy set out a series of recommendations.
With Commissioners including former Chief Executive of NICE, Professor Gillian Leng CBE and former Chief Pharmaceutical Officer at NHS England, Dr Keith Ridge CBE, they recommended that:
- The NHS App should be given a new focus as a location for individuals to consent to participation in health research, with a target of 50% of the population having opted-in to being contacted about relevant research by 2025. This should be incorporated with existing initiatives such as NHS Digitrials, Find, Recruit and Follow Up and NIHR’s Be Part of Research.
- In line with the ICSs’ duty to facilitate research, as set out in the Health and Social Care Act 2022, metrics to measure research activity should be developed at a national level and built into local accountability frameworks.
- DHSC should incentivise and encourage the use of NIHR Guidance on diversity in clinical trials. This includes ethnic, gender and other relevant biological data, as well as diversity in location to make sure to under-represented groups from disadvantaged areas have equal opportunity to take part in trials.
Clinical research has perhaps never been more important than in the past two years. The Coronavirus pandemic meant that clinicians across the world were pressed to find new solutions and treatments for a disease that was sprung on the world population.
Commenting on the news, Curia’s Chief Executive and former Chair of the Parliamentary Group for Rare Diseases, Ben Howlett said: “It is very good news that the Government has appointed James to undertake this important review. The UK clinical research sector faces some serious strategic questions given the economic landscape, regulatory changes caused by Brexit and waiting list pressures faced by the NHS.
“The UK continues to lead the way in ground-breaking research, and I look forward to receiving Lord O’Shaughnessy’s recommendations.”Minister of State for Health, Will Quince MP
“When we first discussed the Commission in 2021, industry was already sounding warning alarms about the attractiveness of the UK life sciences economy. That is why Curia supported the commissioners in making a series of recommendations to improve the infrastructure of the UK clinical research sector.
“Knowing James and how passionate he is about improving the UK clinical research environment, I am confident that he will produce some excellent recommendations that I hope the Government will give serious consideration to.”
Commercial clinical trial recruitment down
The ABPI has outlined a 44% drop in the number of participants recruited to commercial clinical trials in the last five years, exacerbated by the effects of the pandemic. The number of industry clinical trials initiated in the UK per year fell by 41% between 2017 and 2021.
Minister for State at the new Department for Science, Innovation and Technology, and long-standing Life Sciences Minister, George Freeman said:
“Commercial clinical trials are absolutely vital to both our UK life sciences sector and widening NHS patient access to innovative medicines all across the UK.
“The UK has traditionally been a strong global location for trials, as demonstrated most recently through the ground-breaking Covid Recovery trial which was set up in record time and was the world’s largest randomised controlled trial for COVID-19.
“However, our life sciences sector has reported a 44% fall in recruitment of patients to commercial clinical trials between 2017 and 2021 – so it is vital that we act to rebuild competitiveness.
“That is why I’m delighted that Lord O’Shaughnessy will lead this independent review to identify the key steps we need to take.”
Welcoming the announcement, Health Minister, Will Quince, said: “We’re harnessing the same spirit of innovation that delivered the COVID-19 vaccine and working hand in hand with the NHS, industry and healthcare experts to get cutting-edge medicines to patients faster.
“This review will help us to find new ways to conduct commercial clinical trials that will speed up diagnosis, enhance treatment and enable the NHS to deliver world-class care, as well as cementing our position as a life sciences super power.
“The UK continues to lead the way in ground-breaking research, and I look forward to receiving Lord O’Shaughnessy’s recommendations.”
Lord O’Shaughnessy will publish his advice this spring. This will include recommendations of priority actions to make progress in 2023, as well as setting out longer-term ambitions for UK clinical trials.
For those who are regular readers of our final thoughts, I think you already know what we are going to say.
Recommendations are one thing, what you do with them and how you implement them is frankly a lot more important.
No-one can criticise the Government for a lack of policy when it comes to the UK clinical research environment. In fact, many have said it needs streamlining and simplification. However, time and time again, the message has been clear from the sector – the language of policy is misaligned with those who are tasked with the implementation.
Should the recommendations that Lord O’Shaughnessy produce be effective in transforming the UK into a life sciences superpower, then it is important that there is buy-in from the NHS at every level. From the clinical researcher in a district hospital to the Office of Life Sciences, unity of purpose is as important as unity of message.
Ultimately, at the heart of this Review, the patient will benefit from improved outcomes.