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.
From 14 October 2024, NCVR will include Early Phase (phase I and IIa) and Advanced Therapeutic Medicinal Products (ATMPs) studies.
Early impact of NCVR
Improvements to date. Since 2023:
- NCVR has seen a 36% reduction in set-up time in the first 12 month analysis
- Over 1450 reviews completed to date and the median time of these for lead site review is 34 (1 October). The average time to complete the Study Resource Review phase is currently 35 days.
- The average number of NHS research sites per study is 10, and 80% of all studies complete the resource review without the need for site specific escalations.
- In addition to faster set up, NCVR has freed up resources in sites to carry out other set up activity.
- The UK commercial pricing structure, a key component of NCVR, is being incorporated into Medidata GrantsManager - a global commercial budget tool - helping build assurance and accuracy for global life sciences customers at the very start of creating UK country budgets.
National Contract Value Review
For all studies submitted in IRAS or interactive costing tool (iCT)
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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?
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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.
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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.
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 and a webinar hosted by The Research and Development forum, NHS England and NIHR.
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.