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National Directive on Commercial Contract Research Studies


Published: 09 May 2019

Version: 2.0 - August 2023

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What NHS Organisations need to know about operating National Contract Value Review Stage Two in October 2023

Lord O’Shaughnessy’s review of commercial clinical trials in the UK identifies the need to improve the set up of commercial contract research, in order to benefit patients.

The National Contract Value Review (NCVR) is one important UK initiative to address this and ensure full cost recovery for the NHS.

Stage one of the NCVR implementation is now established with over 700 reviews to learn from with an overall price variation of 2-3%. All commercial contract research studies in NHS organisations will continue to benefit from a single study resource review through submission of the interactive Costing Tool (iCT).

However, from October 2023 some aspects of NCVR will change. It will enter stage two of the roll out process aiming for no local adjustments.

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.

What is changing in this next stage of the NCVR from October?

Submission of studies must align with the submission process for regulatory review and approval

This means that Sponsors and Contract Research Organisations (CROs) must request study resource review in the 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.

All NHS organisations are required to accept the Lead NHS organisation review outcome and iCT generated prices for studies in scope of stage two NCVR

This means NHS organisations are no longer able to apply their own local prices for commercial contract research (excluding phase I-IIa, ATMP and Primary Care sites in any study).

To understand more about how the prices are calculated for your NHS Organisation explore our iCT guidance or take a look at our FAQs.

For those studies and site types excluded from stage two of NCVR, all NHS providers are strongly encouraged to accept the outcome and iCT generated prices. A new finance appendix for UK commercial model agreements must be used

This means that only the appropriate UK template agreement without changes should be used. This will also apply to this finance appendix from October 2023.

The iCT generated prices will populate the finance appendix for each site and modification will not be permitted.

Organisation specific prices generated by multipliers in the iCT described below, will be included in a standard template for the financial appendix of the model agreements.

NHS organisations must accept the site-specific multipliers in the iCT to ensure 100% cost recovery for all studies in scope of stage two NCVR

For English organisations these multipliers, already built into the iCT, are based on NHS-wide insights and data gathered by NHS England which is being reviewed to take account of additional need for a no local negotiation position from October for organisations in England. This means that organisations cannot negotiate or charge separately for anything additional where studies are within scope of stage two of NCVR.

For the Devolved Administrations, multipliers have previously been agreed and operationalised under existing processes.

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.

The October values will be road-tested over 6 months and there will be an opportunity to revise these as required to enable no local negotiation. Any changes will be made as part of the annual updates for the new financial year in April. This is overseen by the multi-stakeholder UK Commercial Costing Reference Group - they have looked after the iCT since its creation in 2008.