Image of commercial study depicting the NIHR's national contract value review

Commercial study set-up process over 100 days quicker thanks to national contract value review, new data shows

More data on the impact of the National Contract Value Review (NCVR) has shown it continues to benefit researchers and speed up the time it takes to set up commercial trials.

The data comes from the National Institute for Health and Care Research (NIHR), which has jointly run the NCVR programme since its first implementation in April 2022 in collaboration with NHS England, the Health Research Authority, and the Department of Health and Social Care.

The NCVR is a standardised approach to the costing of commercial contract research, so NHS organisations are not required to negotiate a bespoke contract value with each individual sponsor.

The NCVR is supported by two tools that help NHS organisations expedite study set-up processes. They are the UK interactive costing tool (iCT) which uses a costing methodology to calculate prices for NHS organisations.

The second is a suite of model agreements designed for a variety of research scenarios, which is available via the integrated research application service.

In the last year, more than 60 studies have gone through the entire set-up process – i.e., a national review has been conducted, recruitment has begun and participants have been enrolled.

Analysis of these studies indicates that this process is over 100 days faster and as much as 185 days quicker when compared to data from before the pandemic.

In relation to 12 months ago, the average time taken from costing submission to the first participant consenting to the study has been cut by around 110 days, from 305 days to 194 – the equivalent of a 36% reduction.

NIHR Clinical Research Network’s head of feasibility and start-up, Laura Bousfield, 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.”

She continued: “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.”

The new research comes as NIHR launches the next stage of the NCVR, which will see local negotiation with NHS organisations come to an end – a move expected to further refine set up processes across the UK.

The government and NHS are also working together to bring the benefits of the NCVR to phase I and phase IIa studies, alongside research into advanced therapeutic medicinal products.

With stage one of the NCVR encompassing secondary care settings, national partners have developed a voluntary sign-up scheme for primary care – this will see general practices accept the prices given by the iCT to help generate evidence and support the wider roll-out of the NCVR.

Dr Sam Davies, a GP partner in Bristol who has been a principal investigator for over 30 studies, commented: “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.”

Image credit: iStock

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NHE May/June 2024

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