National contract value review
The national contract value review (NCVR) is a standardised, national approach to costing for commercial contract research.
From 1 October 2022 all new commercial research proposals submitted for a study resource review will undergo a review by the lead site. Following this review eligible studies will enter into the NCVR process.
Eligible studies are all those commercial studies which will be conducted in acute, specialist and mental health trusts in England and counterparts in the devolved administrations, with the exception of phase I – IIa and advanced therapy medicinal product (ATMP) studies. Primary Care settings are not included at this stage.
National contract value review is a UK wide programme
In England, NCVR is being delivered by NHS England in partnership with the National Institute for Health Research and Care (NIHR), The Health Research Authority (HRA) and the Department for Health and Social Care (DHSC).
The NCVR programme is being introduced across the UK. While the processes will be aligned across England, Scotland, Wales, and Northern Ireland there will be some differences to how the programme will be introduced in the Devolved Administrations, for more information see the national contract value review – operational details web page.
There will be reciprocal recognition of contract value reviews conducted by NHS organisations across the UK.
The introduction of the national contract value review process will bring about several benefits
- A new, standardised, national approach to costing for commercial contract research improving consistency in study set-up and making it easier to conduct research.
- Increasing the speed and efficiency of research set up to increase the capacity for more research in the NHS.
- A transparent ‘no surprises’ approach to contract value negotiations between commercial research sponsors and participating NHS organisations..
- Builds on local expertise to establish a national process for defining and allocating resource and procedure requirements.
- By simplifying and improving research arrangements, we can speed up access to new treatments and support patients to receive the best care.
The NCVR focuses on agreeing the resources and price needed to set up research within a NHS provider. 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.
From 1 April 2022, The NCVR began replacing the the current time-consuming process whereby each NHS organisation negotiates with each commercial sponsor for every study in order to agree bespoke contract value. The NCVR process will speed up commercial research set up times and make the UK a more attractive place for international commercial organisations to undertake research studies, ensuring our patients have rapid access to cutting edge treatments.
NCVR core components
Work on the NCVR process began in 2018/19 but was paused due to Covid-19. The NCVR is underpinned by the National standard contract and the National directive on commercial research studies
A staged approach to implementing NCVR is being taken. The first stage began in April 2022.
The final NCVR process will be informed by learning from stage one and the final product will include:
- NHS organisation specific prices will be available to commercial companies prior to site selection,
- Costs will be transparent. A single national negotiation of study costs will take place with no local negotiation.
Stage one of the NCVR implementation has two core elements:
- Data has been collected to identify which NHS organisations have committed to apply the local prices as generated by the standard costing methodology and which may continue to apply their own prices to the resource needs agreed by the national negotiation. The information on adherence will be made available to companies prior to site selection within the iCT tariff workbook
- From October 2022 all eligible commercial study interactive costing tools submitted for a study resource review are included in the National Contract Value Review Process. They will be assigned to a NCVR contract value review coordinator and be subject to a single, national negotiation. This will involve assessment of the consistency of the research study protocol activities and the completed interactive costing tool, together with the negotiation of the resource required to deliver the protocol at any UK-based NHS location. NCVR contract value review coordinators will carry out the review.
Detailed operational/technical information on Stage One of NCVR Implementation including detailed requirements for NHS study site can be found on our national contract value review – operational details web page.
User resources for the interactive Costing Tool and the role of iCT in supporting NCVR