|
Lord O'Shaughnessy’s review of commercial clinical trials in the UK makes it clear that we must improve study set-up to attract more commercial contract research to safeguard opportunities and better treatments for patients.
National Contract Value Review (NCVR) is one important UK initiative to improve the set-up of commercial studies. The government’s response to the O’Shaughnessy review recognised the value of our consistent approach to study resource review, pricing and contracting, with an action to accelerate the impact of NCVR.
From October 2023 some aspects of NCVR will change as it enters stage two of its roll-out, following the implementation of NCVR stage one in October 2022.
All commercial contract research studies to be undertaken in the NHS throughout the UK will continue to benefit from a single study resource review, through submission of the interactive Costing Tool (iCT), regardless of whether they are included in the scope of stage two of NCVR.
Which studies are in scope of NCVR stage two?
The scope of NCVR remains unchanged. All commercial contract research to take place in the NHS is in scope, with the following exceptions: phase I-IIa, advanced therapy medicinal product (ATMP) studies and studies carried out in independent contractor primary care.
It is our intention that the studies excluded from stage two will be in receipt of the full NCVR process as soon as possible.
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 of NCVR.
This means that organisations are no longer able to apply their own local prices for commercial contract research (excluding phase I-IIa, ATMP and studies carried out in independent contractor primary care).
For those studies excluded from stage two of NCVR (phase I-IIa, ATMP, and studies in independent contractor primary care), all NHS organisations are strongly encouraged to accept the outcome and iCT generated prices.
A new finance appendix for UK commercial model agreements must be used.
It is currently mandated that only the appropriate UK template agreement is used and that it is used without modification. From October 2023, each commercial UK template agreement will include a new finance appendix and the obligation of unmodified use will extend to this appendix.
The sponsor will use the outcome of the NCVR negotiation process to populate each organisation’s finance appendix with the study budget. Modification will not be permitted by sponsor or NHS organisation.
Each organisation’s study budget will include site-specific multipliers, designed to ensure full organisational cost recovery.
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 updates to these multipliers, already built into the iCT, will be based on NHS-wide insights and data gathered by NHS England. This data 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 built within the iCT 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.
Please ensure this information is shared with relevant people within your organisation.
|
