It’s been a fast-moving, all-encompassing but highly rewarding time for research in the NHS in recent months. The UK has played a significant global role in coronavirus research, producing some of the most important evidence for managing COVID-19.
Dr Janet Messer, Director of Approvals Operation at the HRA
At pace, when they were most needed, clinical and research services for COVID-19 were switched on rapidly and efficiently, but unfortunately this has been at the cost of research in other disease areas and it’s becoming evident that the NHS seems to be struggling to get other clinical and research activity running again. There are lots of complex reasons for this, but here at the HRA we’re interested in what we can do collectively to move forward. There are big stakes here. It’s not just about the wider health of the population from research evidence that is at risk, but the everyday benefits to the NHS of being involved in research: income from research, treatments that are delivered through research, and a workforce that is engaged in critically assessing the evidence for care. All of that, and much wider economic impact, is at risk if companies no longer place research in the UK.
It was against that backdrop that two recent significant meetings took place: a conference hosted by the UK BioIndustry Association (BIA) with the Medicines and Healthcare products Regulatory Agency (MHRA), and a round-table meeting hosted by Lord Bethell, Minister for Innovation in the Department of Health and Social Care.
Speeding up patient-centred research
The clear feedback from the bioscience companies present at the first conference, and from the wider range of companies at the second meeting, was that industry needs a faster route in the UK to get products through to patients, and that those products need to be focussed on the needs of patients. This is not a new message, but the combination of circumstances around us now means that we need to put in place a heroic and urgent response, and get the basics right. That means we need what one delegate aptly called the quadruple helix: academia, industry, government and the public to work together. That collaboration needs to ensure innovation in regulation to support regulation of innovation.
MHRA shared information about its proposals for an innovative licensing pathway to support efficient and timely medicines development. It was encouraging to hear about the emphasis on patient involvement throughout these proposals.
Clinical trials are a key part of the licensing pathway that both meetings focussed on. Delegates at the BIA conference heard about the success of the Combined Ways of Working pilot, which is providing an integrated review by MHRA and the Research Ethics Committee, with a single application and single decision. Industry shared their experiences of reduced and more consistent timelines in the pilot. This is great progress and will help us to deliver the basics solidly. But we are going to need more than that. Learning from the experience of COVID-19, the MHRA is proposing a pre-assessment advice service and HRA is exploring expanding its fast-track REC review option.
The UK also needs to be competitive in terms of patient recruitment, study start-up and quality. Data shared at the conference showed the good position the UK already holds, but there is no room for complacency. The good news is that the collective activity of a range of organisations really has potential to take us from a heroic short-term response to COVID-19 to a sustainable, efficient and effective optimal future clinical research position.
Transforming the research ecosystem
We heard from Lord Bethell at the round-table meeting about the Government’s commitment to clinical research. He described ambitious proposals to the Comprehensive Spending Review to transform the UK clinical trials ecosystem by enabling rapid approval, set up, recruitment and delivery of research across the NHS, powered by new technologies, data and innovative approaches.
We heard about proposals for a ‘Find, Recruit and Follow-up’ service that will enable electronic health information to be used to identify sites with suitable patients, to offer patients opportunities to participate in clinical trials, and to follow up research participants. There was commitment to improving the speed and efficiency of costing and contracting. And there was a focus on ensuring research continues to improve how patients and the public are involved in shaping research, and that research reaches more diverse and underserved populations.
Bringing trials to patients
But the collective view of those at the meeting was that the most important and transformative intervention would be to make use of individual and organisational drivers to enable the behaviour change needed for clinical research to become business as usual across the health and care system. Much of the discussion focussed on how NHS organisations need to recognise the importance and value of research. But there was also a recognition that collectively we need to do more to bring trials to patients rather than patients to trials. That means thinking creatively about how we use technology to reach and monitor patients outside of traditional settings.
As I started off saying in this blog, research is enormously important to NHS organisations. But most people who happen to be patients spend most of their time outside the NHS. I was left wondering what is stopping research sponsors from designing trials around patients rather than designing trials for teaching hospitals? Surely restarting non-COVID trials provides an incentive for sponsors to challenge themselves on all the ways in which they can find, recruit and follow-up patients?
Sheuli Porkess from the Association of the British Pharmaceutical Industry gave an excellent summary at the end of Lord Bethell’s meeting: ‘to be a world leader in clinical research, the UK needs to be able to offer delivery, continuity, quality and efficiency for all trials, large trials and small trials, in hospital and out of hospital, simple and complex, for all patients and all healthcare professionals.’