The national contract value review (NCVR) is a standardised, national approach to costing for commercial contract research.
The NCVR is underpinned by the National standard contract and the National directive on commercial research studies. The NCVR focuses on agreeing the resources and price needed to set up commercial research studies within NHS providers. 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 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.
All commercial research proposals submitted for a study resource review undergo a review by the lead site. Following this review eligible studies will be entered into the NCVR.
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 and Care Research (NIHR), The Health Research Authority (HRA) and the Department for Health and Social Care (DHSC).
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.
There is reciprocal recognition of contract value reviews conducted by NHS organisations across the UK.
Early impact of NCVR
In the first 6 months of NCVR over 200 studies have completed the study resource review and the first studies having started recruiting. The average time to complete the Study Resource Review phase is currently 29 days. The time taken from costing submission to first patient recruitment has reduced by 45% (from an average of 213 days to 118 days). The average number of trust research sites per study is 10, and in addition to faster set up, NCVR has freed up resource in sites to carry out other research activity.
National contract value review stage two
The Government’s response to Lord O’Shaughnessy’s review of commercial research sets out the Government’s commitment to enhance the current NCVR model and expand its use in set up of Early Phase (phase I and IIa) and Advanced Therapeutic Medicinal Products (ATMPs) studies.
From October 2023 some aspects of NCVR will change as it enters stage two of a staged roll out process:
- Requesting study resource review
- Sponsors and Contract Research Organisations (must request a study resource review via the interactive Costing Tool (iCT) immediately prior to IRAS (Integrated Research Application System) submission for regulatory review. Where technical assurance review for pharmacy and/or ionising radiation applies, iCT submissions should be made after technical assurance review validation.
- Single study resource review and local price generation
- All commercial contract research studies to be undertaken in NHS organisations throughout the UK will continue to benefit from a single study resource review through submission of the interactive Costing Tool (iCT).
- Following this review the iCT will generate site specific prices for all commercial contract research in the NHS, other than phase I-IIa, ATMP studies and studies carried out in independent contractor / Primary Care.
- Site specific multipliers are being revised in England to take into account local variations (see below).
- All NHS organisations are required to accept the single study resource review outcome and the local price generated by the iCT for studies in scope of stage two NCVR. Sites will no longer be able to apply their own local prices for commercial contract research.
This excludes phase I-IIa, ATMP and studies in Primary Care studies, although NHS organisations are strongly encouraged to accept the outcome and iCT generated prices for these studies.
- NCVR is being introduced for ATMP and early-stage studies, with early work underway to explore the best way to operationalise this.
- Use of new finance appendix
- A new for finance appendix for UK commercial model agreements is being developed.
- The current mandate to use the appropriate UK template agreement without modification will apply to this finance appendix from October 2023.
- Site specific prices generated in the iCT will be included in a standard template for the financial appendix of the model agreements and local modification will not be permitted.
Site specific multipliers
Site specific multipliers are already built into the iCT and are used by all four UK nations.
For English organisations these multipliers are being revised and updated; via the Clinical Research Network CRN, in light of NHS-wide insights and data gathered by NHS England. They are being revised so that multipliers incorporate provisions for third party outsourcing and site-specific research activity which are the reasons sites give for variation from the generated iCT price. The aim of site-specific multipliers is to ensure 100% cost recovery across a site’s commercial research portfolio of studies in scope for NCVR.
For the Devolved Administrations, multipliers built within the iCT have previously been agreed and operationalised under existing processes.
For further information on devolved administrations NCVR delivery see:
- NHS Research Scotland
- Faster costing and contracting for research delivery in the UK: Health Care Research Wales
- Health and social care research in Northern Ireland
The multipliers for English organisations will be updated within the iCT in October 2023 and will be used as part of the iCT calculation to create site level prices which cannot be negotiated.