Faster costing for commercial research in the UK
Costing commercial research in the UK
The way commercial research is costed and negotiated in Wales and across the UK has changed to improve consistency and reduce unnecessary delays to study set up through a process known as National Contract Value Review (NCVR).
What is national contract value review?
NCVR is a standardised, national approach to costing for commercial contract research and focuses on agreeing the resources and price needed to set up commercial research studies within NHS organisations. 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 process builds on what has been achieved with the UK commercial Costing Template (NIHR interactive Costing Tool - iCT) to create a single contract value review with an assigned National Resource Reviewer for each commercial contract study within the UK. There is reciprocal recognition of contract value reviews conducted by NHS organisations across the UK.
Early impact of NCVR
Stage one of NCVR was implemented from the 1st October 2022. In the first six months of NCVR, over 200 studies had completed the NCVR study resource review. The average time to complete the study resource review phase was 29 days. The time taken from costing submission to first patient recruitment had reduced by 45% (from an average of 213 days to 118 days). The average number of UK NHS 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
During October 2023 some aspects of NCVR will change as it enters stage two:
For all studies submitted in IRAS or interactive costing tool (iCT) from Sunday 1st October 2023:
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there is no local NHS site price negotiation;
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all commercial UK template agreements will include the new financial appendix;
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the financial appendix is mandated for use, unmodified;
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the IRAS and iCT submissions will be made at the same time;
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study resource reviews will be managed under stage two principles;
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iCT national review is shared with applicant rather than site. The applicant copies the organisation-specific iCT finance schedule into the new template contract appendix, to be shared with site. Sites will still receive the full organisation-level budget detail from the iCT, to support invoicing and internal disbursement, as sponsors will provide this.
As a sponsor, what I need to do from 1 October 2023?
From 1st October 2023 you must:
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submit your iCT for study resource review at the same time as your IRAS submission;
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include the appropriate new UK template agreement, with the new financial appendix, in your IRAS submission. Do not use any previous agreements for any IRAS submission on or after 1st October;
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copy the iCT finance schedule, when available, into the financial appendix of the agreement to share with sites;
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complete the site iCT process, before sharing the locked-down site-level iCT with the site inside CPMS. This should be done at the same time as sharing the completed contract template with the site, to support site invoicing and internal disbursement.
What is changing on 18th October 2023?
The interactive Costing Tool (iCT) will be updated to include:
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new functionality, including tiered R&D set up, coordination and close down fees and revised time-based calculations, replacing some unit costs;
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investigations will uplift based on price variation and outsourcing analysis, with changes visible in the iCT tariff workbook;
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for England only, site multipliers are being incorporated through a revised Market Force Factor value for research. This change applies at the point of creating site specific versions and will be visible in the iCT tariff workbook. The Market Force Factor for Wales, Scotland and Northen Ireland are remaining the same.
Items such a participant travel or subsistence allowance will be pass through costs and not listed within the budget. The new UK finance appendix allows for sponsors to cap such pass-through costs per visit, with costs incurred over the cap requiring sponsor authorisation.
What does this mean for sites currently in set up from 18 October 2023?
Any agreement not exchanged (signed by both parties and notified / returned to the sponsor) will need to follow NCVR stage two from 18 October 2023. This means that any studies in set up with unsigned contracts will need to use the revised contract template, with new financial appendix and iCT generated finance schedule. For sites where contract exchange has not happened before 18th October 2023, the iCT generated budget will apply without local negotiation.
What does this mean for sites currently in set up from 18 October 2023?
Which studies are in scope of NCVR stage two?
During stage two the full NCVR process (lead NHS site review and iCT outcome acceptance) remains applicable to all commercial contract research in the NHS.
The only exceptions are:
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Phase I-IIa studies.
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Advanced therapy medicinal product (ATMP) studies.
Work is underway to bring these studies into the full NCVR process as soon as possible.
For any studies (both included and excluded) taking place within independent contractor / Primary Care sites, these sites do not have to accept the iCT outcome. A voluntary adherence scheme is currently being implemented to bring more research settings into the full NCVR process.
Where can I get more information and support with the NCVR process?
In Wales, NCVR is being delivered by Health and Care Research Wales in partnership with the NHS organisations across Wales.
For more information and support please email the Health and Care Research Wales support and delivery service.
There are a number of useful UK NCVR resources available on the NIHR website.
While processes will be aligned across Wales, England, Scotland and Northern Ireland there are some slight differences within each nation to how the programme is being implemented. More information can be found on each nation’s website:
Health and social care research in Northern Ireland
What is the escalation process for NCVR?
There is an NCVR escalation pathway to understand when and how to escalate issues or errors with the NCVR review, or wider NCVR programme. Escalations are managed by a nation-specific ‘one point of contact’ approach to prevent reviewers being contacted by multiple sites. For Wales, this is being managed by Health and Care Research Wales Research Funding Team who can be contacted via email.
An infogram has been co-created by the four UK nations which provides information on the UK NCVR escalation pathway.