Published: 24 March 2023
One year into the Research Reset programme, Professor Lucy Chappell, NIHR Chief Executive Officer, reflects on what has been achieved so far and the work still to do to ensure that we build back a thriving and sustainable research portfolio across the health and care system.
A thriving portfolio of research and innovation across the health and care system is a crucial part of improving care and outcomes for patients and the public. We saw in the COVID-19 pandemic that research enabled vaccines and treatments to be developed at pace and scale, enabling us to move out of the pandemic. Our vision is that an effective and efficient research system becomes the norm, with research embedded across the health and care system. It should be underpinned by strong science and deliverable studies, achieving clear impact for patients and the public.
Since March 2022, the Department of Health and Social Care and NHS England have led a comprehensive review of the national clinical research portfolio as part of the Research Reset process. Following the impact of the pandemic on clinical trials, Reset is ensuring the UK has a thriving, sustainable and diverse R&D portfolio, giving as many studies as possible the chance to deliver results.
Through the process, study sponsors, funders and chief investigators have critically reviewed their studies and taken action on those studies considered ‘off track’ i.e. those struggling to set up, recruit participants, or deliver within an agreed timescale. This is part of normal portfolio management, but was paused during the COVID pandemic as everyone pivoted to delivering focused research studies.
One year into the Research Reset programme, I would like to thank everyone who has worked tirelessly to support this process. They have helped to build a more resilient and balanced national portfolio, securing the UK’s capacity to deliver clinical research and continuing to ensure the UK’s economy can thrive.
There is still more to do, but the NIHR Clinical Research Network (CRN) portfolio data shows increasingly encouraging signs of improvement. In the March 2023 data cut:
- 57% of the portfolio is on track for delivery to time and target, up from 24% in October 2022.
- We have nearly 6,000 studies within the NIHR CRN portfolio, nearly 500 more than there were in 2019, with 80% of these open and recruiting.
- We are recruiting more people to studies (around 71,000 per month), than prior to the pandemic (approx. 61,000 per month).
- The backlogs are clearing, with the number of studies in set-up down to 20% (close to pre-pandemic levels), reduced from a peak of 27% in July 2021.
We are continuing to work with sponsors and funders towards the target of achieving 80% of NIHR CRN studies delivering to time and target by June 2023. Reset has involved a lot of tough choices. But sponsors and funders have told us that it has enabled them to review their portfolios and identify which of their studies have the greatest chance of delivering the research that could improve patient outcomes.
An opportunity for growth
Commercial contract studies are critical to developing new medicines and devices for the benefit of patients and the NHS, as well as helping to grow the economy. As set out in the Government’s Future of UK Clinical Research Delivery and the Life Sciences Vision, creating a strong portfolio of commercial contract research helps to sustain other research taking place across the UK and provides a vital income to maintain and grow research delivery at NHS sites.
Commercial contract studies have not been recovering at the same rate as other research. Therefore we have introduced a series of activities that together will boost set up and delivery of commercial studies:
- NHS R&D offices have been asked to expedite the setup and delivery of contracted globally competitive commercial contract studies with immediate effect. The NIHR CRN will be supporting sites to focus on setup and other support activities, on top of our Study Support Service.
- The Health Research Authority (HRA) now offers a fast-track service for research applications that need a rapid research ethics review, together with its Combined review pathway with MHRA, in order for the UK to set up globally competitive trials quicker.
- The UK-wide standardised National Contract Value Review has been introduced to streamline the commercial costing processes. This will help improve consistency in study set-up, and also increasing the speed and efficiency of research.
By introducing this package of activities across the pipeline now, we continue to improve the country’s thriving competitive life science sector, alongside the wider portfolio of research funded by the public and the charity sectors.
We have already made considerable progress in improving the UK’s clinical research environment to date. Work continues to ensure the UK is one of the best places in the world for health and care research and development, for all stakeholders, and that as many people as possible have the opportunity to participate in and benefit from research.
"In my experience, waiting and not knowing is worse than being told 'sorry - this trial is not going ahead'. At least you can then make an informed decision to go straight to a standard-of-care option, or consider another trial that you may also be eligible for.
Delays to clinical research studies can be very worrying and cause additional anxiety as one more thing to deal with, in an already stressful situation. If there is then a delay in the research study, the patient is in limbo - not wanting to start standard-of-care treatment which will make them ineligible for the trial but not able to receive potentially life-extending or life-saving treatment and 'feeling' that their condition is worsening with every day of delay.
To the patient, research can only make a difference if it is improving the understanding of their condition while helping them – and others in a similar position in the future – to get better. A study that isn’t able to reach participants simply can’t have an impact on the patient’s health.
I am sure stopping or ending a trial is a tough call but better a quick clean decision than a slow, painful and inevitable shutdown. It allows patients to move on to other options that might include different, more viable studies without delay.
It’s really encouraging to see that this process is being taken, and to see that so much other work is being carried out to improve clinical research ultimately for the benefit of patients in our NHS."
Ifeanyi Sargeant, patient representative