A new, standardised, national approach to costing and contracting for commercial contract research (CCR) is being introduced across NHS sites in England to improve consistency and reduce unnecessary delays to study set-up.
The new arrangements will introduce greater certainty for NHS providers and industry. The scope of the new arrangements includes multi-site studies and excludes phase 1, phase 2a, ATIMPS and primary care studies at this stage.
The National Contract Value Review process brings together three key elements to improve commercial contract research set-up:
- Mandated use of an unmodified model site agreement and standard costing methodology from 1 October 2018 including the use of the new interactive Costing Tool (iCT) from June 2019
- Establishing standards for nationally defining and allocating commercial study resource and procedure requirements
- Introduction of a national coordinator role responsible for completing the National Contract Value Review for the study, ensuring that NHS providers recover all justified costs associated with delivering a commercial research study
A phased approach to implementation of the new process will be adopted to allow the model to be refined and tested with the engagement of stakeholders.
- Phase 1 February – June 2019 – complete.
- The first phase focused on understanding the intra-study variability in study costs and resource allocation across organisations to inform training requirements and National Coordinator models.
- Phase 2 & 3 July 2019 – April 2020 – in process
- The aim of phases 2 and 3 is to further test and refine the National Contract Value Review process using live studies. Study stakeholders will be closely supported by CRN staff, to ensure the process runs smoothly, collecting feedback which will shape the final process and the national coordinator role.
- All 34 NHS organisations involved in phase 1 have been invited to continue into phase 2. The first wave of training has been provided to volunteer National Coordinators from R&D teams, with further training sessions for R&D teams and Industry delivered throughout this period.