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Commercial study set up times reduced by a third

nurse group meeting

Published: 26 October 2023

New NIHR data 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.

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 take part 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. He has been a Principal Investigator for 30+ studies for South Gloucestershire Medical Research Unit. 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.”

UK wide collaboration

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.

The NCVR is part of the UK programme Saving and Improving Lives: The Future of UK Clinical Research DeliveryFurther information on the National Contract Value Review is available on the NIHR website.

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