Commercial study set up times reduced by a third, according to new data
October 26, 2023 – Clinical Trials – clinical trials, National Contract Value Review, NIHR
26 October 2023 — London, England — New data from the National Institute for Health and Care Research (NIHR) shows that the National Contract Value Review has significantly reduced the time it takes to set up commercial studies in the NHS.
Commercial studies are achieving study set-up milestones over 100 days quicker on average, since the National Contract Value Review (NCVR) process was introduced 12 months ago.
This increased speed and efficiency of research set-up together with improved consistency in multi-site study costing, bolsters the UK’s position as an attractive place for health and care research.
The NCVR process, is the UK’s standardised, national approach to costing and contracting for commercial contract research. It is a UK-wide programme led by NHS England in partnership with DHSC, NIHR Clinical Research Network, the Health Research Authority and the devolved administrations for the benefit of patients and the public.
Positive results from phase one of NCVR are encouraging news as stage 2 of implementation commences this month.
Quicker set-up times
Within the last 12 months, over 600 studies have had a national review completed and over 60 have gone all the way through the set-up process. This means they have had a national review conducted, opened to recruitment at participating sites and participants have been enrolled in the study.
An analysis of these 60+ studies confirms that:
- Set-up times are over 100 days quicker and as much as 185 days quicker when compared to the pre-pandemic data for 2019/20.
- When compared to the 12 months prior, the average time from initial costing submission to the date of the first participant consenting to participate in the study, has reduced from 305 days to 194 days; a reduction of 110 days or 36%.
Analysis of the data will continue as more studies complete the NCVR process.
Laura Bousfield, national head of Feasibility and Start-up, NIHR Clinical Research Network said: “This analysis demonstrates the efficiencies that can be achieved with a system-wide costing tool and model agreements; reducing not only time but resource and duplication of effort. With the next stage of roll-out removing modifications, we can continue to demonstrate that this approach removes costing and contracting delays for patient access to research.”
Professor Lucy Chappell, chief scientific adviser to the Department of Health and Social Care and CEO of the NIHR said: “The impact being made by NCVR is a real positive step for the life sciences industry, for health and care research and most importantly for patients and the public. By working closely with our partners, we have made excellent progress in improving the costing and contracting aspect of study set-up times for commercial studies and we will now explore other ways in which we can further speed up patient access to research. The UK is already one of the best places in the world to do research and this latest positive news provides yet more impetus for all key stakeholders, including the life scenes industry, to continue to work with us to drive further improvements.”
Alastair Nicholson, head of Co-ordination and Standardisation at the Health Research Authority, said: “We understand how important it is for site set-up to be predictable, consistent and fast. Removing local contract and contract value negotiation and replacing them with standard templates and transparent, up-front prices, is a huge step towards this. NCVR demonstrates what we can achieve when working in partnership with industry, the NIHR, the NHS and the devolved administrations. We hugely appreciate the support of all our partners in bringing about this change quickly, and we are excited to continue working together to make the UK the easiest place in the world to do research that people can trust.”
NCVR stage 2 roll out
Stage 2 of the NCVR which commences from October 2023, brings an end to local negotiation with NHS organisations. This is expected to further improve commercial set up timelines across the UK.
Bringing the benefits of NCVR to ATMPs and early phase studies
The NCVR national partners are committed to bringing the benefits of the current NCVR model to the set up of Early Phase (phase I and IIa) and Advanced Therapeutic Medicinal Products (ATMPs) studies. NCVR is being introduced in a small number of ATMP studies to test and refine the process.
Dr Jennifer Harris, ABPI director of Research and Development policy at the Association of the British Pharmaceutical Industry (ABPI) said: “We welcome the significant improvements to commercial clinical trial set-up timelines through the implementation of the National Contract Value Review. Standardising costing and contracting is an approach that has been successful in other countries, so we’re keen to see this roll out nationwide. The progress being made here demonstrates that steps forward are being taken in the UK clinical trial ecosystem, helping to rebuild our reputation as a destination of choice. The next phase of NCVR is set to bring even further improvements to study set-up and we look forward to working with NHS England, HRA, NIHR and the devolved administrations on that.”
Bringing the benefits of NCVR to primary care
Whilst the data for stage 1 encompasses secondary care settings, work is also underway to bring the benefits of NCVR to primary care. A national voluntary sign-up scheme for primary care has been developed whereby general practices agree to accept the prices generated by the iCT to develop the evidence and support the wider roll out of NCVR in primary care.
Dr Sam Davies is a GP Partner at West Walk Surgery in Bristol and has been a principal investigator for 30+ studies for South Gloucestershire Medical Research Unit, UK. He has extensive experience of contract and budget negotiation with over 20 different Sponsors. He says: “The contracts and costings process during the setup of research studies in general practice is often challenging, time-consuming, and has the potential to create conflict at an early stage of a new collaboration between site and sponsor. The NCVR represents a fantastic opportunity for primary care to take advantage of nationally negotiated terms. It should free up site time and expedite study setup, contributing to efficient recruitment and improved relationships, whilst ensuring our work is appropriately remunerated.”
The NCVR focuses on agreeing the resources needed to deliver the study within an NHS provider and uses the UK iCT to generate each NHS provider specific price. This work forms part of a broader common goal to ensure clinical research continues to thrive in the UK, for the benefit of patients and the public.
Further information on the National Contract Value Review is available on the NIHR website.
About the NIHR
The National Institute for Health and Care Research (NIHR) is the nation’s largest funder of health and care research. The NIHR:
- Funds, supports and delivers high quality research that benefits the NHS, public health and social care
- Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
- Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
- Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
- Partners with other public funders, charities and industry to maximise the value of research to patients and the economy.
The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government. Visit: www.nihr.ac.uk
Health Research Authority (HRA)
The Health Research Authority (HRA) is a non-departmental public body, set up in 2011 with a mission to protect NHS patients, their tissue and their data when they are involved in research. The HRA is one of a number of bodies responsible for the regulation and governance of health and social care research in the UK. Researchers wanting to undertake a study apply to us for HRA Approval, which brings together the assessment of governance and legal compliance, with the independent Research Ethics Committee (REC) opinion to confirm whether a research study has all the necessary approvals in place from the relevant bodies to proceed. To find out more about the Health Research Authority visit www.hra.nhs.uk
About Health and Care Research Wales
Health and Care Research Wales is the delivery arm and external brand of the Welsh Government’s Health and Social Services Research & Development Division. Health and Care Research Wales works in partnership with the NHS, universities, local government, other research funders, patients and the public to fund, support and increase research that can transform lives, promotes economic growth and advance science. For more information visit: www.healthandcareresearchwales.org
NHS Research Scotland
NHS Research Scotland is a partnership of Scottish NHS Boards and the Chief Scientist Office (CSO) of Scottish Government supporting the placement, set up and delivery of clinical research studies and innovative research collaborations from all sectors and therapy areas. Visit: www.nhsresearchscotland.org.uk.
About Health and Social Care Research & Development (Northern Ireland)
Health and Social Care Research and Development (HSC R&D) Division is responsible for the administration and coordination of the HSC R&D budget on behalf of the Department of Health NI. Its work is based on the principle that the best health and social care must be underpinned by knowledge, based on well conducted research, which can then be applied in the delivery of care. Visit: research.hscni.net.