NHS trusts can now claim back more of the costs involved in carrying out clinical research following a national policy change. Dr William van’t Hoff is calling for trusts to use this additional funding as an incentive to further support and embed clinical research delivery – benefitting their staff, patients and the communities they serve.
The pandemic has proven that clinical research saves lives. The RECOVERY study, which the National Institute for Health and Care Research supported, gave the world its first life-saving covid-19 treatment, dexamethasone. Within a year, it had saved an estimated 22,000 lives in the UK and more than a million worldwide. None of this could have happened without the contribution of over 200 NHS trusts and thousands of clinicians who worked on the study at incredible pace and in extraordinary circumstances.
This world-leading effort demonstrates the power and potential of research in the NHS. We also know that research-active NHS trusts achieve better outcomes for their patients – even for patients not involved in research. Additionally, including research in job descriptions can improve staff recruitment and retention. Yet research activity amongst trusts varies hugely – both by the size and type of trust, and by region.
A significant barrier preventing trusts from taking on research for their patients has been the process around claiming back “excess treatment costs”. ETCs are the costs incurred by NHS providers in delivering non-commercial clinical research, when the research treatments given to participants are more expensive than the treatment that the patient would have otherwise received. Secondary care NHS trusts in England recoup these costs from NHS England via service commissioners.
NIHR data shows that in the first quarter of 2022-23, the number of NHS trusts taking on research and surpassing their threshold levels, therefore becoming eligible for ETC payments, increased by 183 per cent from the first quarter of 2021-22
Until April this year, a trust had to spend a set minimum of its operating budget on clinical research in order to exceed a threshold for claiming ETCs. As a result, many trusts turned down the opportunity to carry out clinical research on the basis that they might not exceed the threshold and therefore not recover the costs. The NIHR supports the allocation of ETCs to NHS trusts involved in delivering studies, on behalf of NHSE. Our data shows that in 2020-21, 85 per cent of trusts incurring ETCs did not receive any payment. The system had clearly not served trusts well – and had become a major impediment to research in the NHS.
Using this data, the NIHR worked with NHSE and the Department of Health and Social Care to reach a landmark agreement earlier this year to cut the financial threshold for ETCs by 90 per cent – lowering a hugely restrictive bar. This change is pulling away barriers which have stymied clinical research for years and will provide new opportunities to trusts which have previously provided minimal research activity for their local communities and patients. At a time when health inequalities are increasingly apparent, the change to the ETC threshold should catalyse growth in research across the breadth of NHS trusts over the entire country.
Simplifying the ETC process should make it easier to reclaim more of the costs involved and means research is a more achievable and viable prospect for many more NHS providers. As a result of these changes, matched by a 40 per cent increase in funding for ETCs, 120 more NHS sites who previously would not have qualified are now set to receive ETC payments – a quadruple rise. Not only are NHS sites going to benefit from additional funding, they will also access it earlier in the financial year.
A powerful impact and further developments
The change to ETC thresholds is already having a significant impact. NIHR data shows that in the first quarter of 2022-23, the number of NHS trusts taking on research and surpassing their threshold levels, therefore becoming eligible for ETC payments, increased by 183 per cent from the first quarter of 2021-22. A recent survey amongst R&D Directors in the UK has also indicated that the amended ETC policy should improve NHS site participation in research with 65 per cent of respondents agreeing this would lead to an increase.
Alison Austin, NHSE’s deputy director for research commented on this news recently and said: “The majority of studies carried out in the NHS are funded by non-commercial bodies, so public sector and charities, and these studies are eligible for ETCs. The reduction in the ETC threshold will mean that more providers will receive ETC, encouraging more hospitals to take part in more non-commercial trials, helping get the best new treatments to UK patients faster.”
Working alongside NHSE and learning the lessons from our research response to covid-19, the NIHR is helping to further develop our incredible research environment – making England one of the best places in the world to undertake research. We know from the pandemic, just how engaged and invested people can be about health research, especially when it is taking place in their local community.
This development is fantastic news for researchers and NHS trusts and will free up our research community to do more research and do it faster. The NHS, working with NIHR and partners, achieved the world’s best covid-19 research during the pandemic. We want this to be the stimulus for every NHS trust and health and care professional to become research-active – from frontline clinical staff, to management and leadership. We want the NHS managers and R&D teams reading this to work with their finance departments to recognise the changes we are making to simplify research set-up and enable trusts to open up more research. We want them to learn more about reclaiming costs. Ultimately, we want them to make this the year where we unlock the full potential of clinical research in the NHS.
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