Commercial Research update

From Mid-October as part of work to improve the set-up of commercial studies in the UK, local contract negotiation is changing in Stage 2 of the National Contract Value Review (NCVR) which was implemented in response to Lord O’Shaughnessy’s independent review of commercial clinical trials

What is changing?

For all studies submitted from Sunday 1 October 2023:

• Regulatory and costings submissions will be made at the same time
• The budget will be shared with the lead applicant (lead NHS site) for national costing. This finance schedule will be put into a new template contract appendix, to be shared with sites
• There is no local site budget negotiation as the financial appendix is mandated for use, unmodified.
• From 18 October, any contract not already agreed will need to follow NCVR stage 2.
• The aim is to speed up commercial trial setup so sites can concentrate on assessing resource to provide capacity and capability to deliver the trial.
• Further information available here.  

Which studies are affected?

All commercial contract research to take place in the NHS across the UK is planned to be in scope of NCVR. There are some exceptions for stage two: phase I-IIa, advanced therapy medicinal product (ATMP) studies and studies carried out in independent contractor primary care.

Studies excluded from stage two in the NCVR process will be included as soon as possible.