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Key changes to costing commercial research

23 October

As part of work to improve the set up of commercial studies and in response to the Lord O’Shaughnessy’s review of commercial clinical trials in the UK, some aspects of the way costing is negotiated, through the process known as National Contract Value Review (NCVR), are changing.

What is changing with NCVR stage two during the month of October?

From the 1st October 2023

For all studies submitted in the Integrated Research Application System (IRAS) or interactive costing tool (iCT) from Sunday 1st October 2023:

  • there will be no local NHS site price negotiation;

  • all commercial UK template agreements will include the new financial appendix;

  • the financial appendix is mandated for use, unmodified;

  • the IRAS and iCT submissions will be made at the same time;

  • study resource reviews will be managed under stage two principles;

  • 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:

  1. submit your iCT for study resource review at the same time as your IRAS submission;

  2. 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;

  3. when available, copy the iCT finance schedule into the financial appendix of the agreement to share with sites;

  4. 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:

  • new functionality, including tiered R&D set up, coordination and close down fees and revised time-based calculations, replacing some unit costs.

  • investigations will uplift based on price variation and outsourcing analysis, with changes visible in the iCT tariff workbook.

  • The Market Force Factor for Wales, Scotland and Northen Ireland are remaining the same. 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. 

  • 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. 

The owners of the iCT (NIHR) are currently updating the iCT user guide and NCVR resources to reflect stage two.

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.

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:

  • Phase I-IIa studies
  • 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 explored to bring more research settings into the full NCVR process.

Dr Helen Hodgson, Senior Research Funding, Portfolio and Directory Manager at Health and Care Research Wales said:

We have already seen benefits to this UK initiative. Stage one of this process saw the time taken from costing submission to first patient recruitment reduce by 45% and in addition to faster set up, NCVR has freed up resource in sites to carry out other research activity.

We’re looking forward to seeing how these new changes make it easier to conduct research here in Wales and ensure full cost recovery for the NHS.”

Your feedback is important to us.

For more information about the NCVR process, please visit our website Faster costing for commercial research in the UK | Health Care Research Wales (healthandcareresearchwales.org)

Please contact the Research Funding Team if you have any questions or queries - research-fundingsupport@wales.nhs.uk