|
In early July the HRA and the devolved administrations will launch a two-week call for comments from NHS organisations, commercial sponsors and CROs. We'd like your feedback on a draft unmodifiable financial appendix, which will be added to the UK’s existing suite of model agreements for Commercial contract research studies.
Following the publication of Lord O’Shaughnessy’s independent review of commercial clinical trials, the government has committed to implementing an unmodifiable financial appendix that will remove local contract and contract-value negotiation from the National Contract Value Review (NCVR) process from 1 October 2023. The new appendix will have standard clauses, incorporated into each of the UK model agreements and a finance schedule, generated for each study by the interactive Costing Tool (iCT), following conclusion of the national study resource review.
Streamlining study set-up processes is vital to ensuring patients have access to research and is a top priority of the UK’s vision for clinical research. The NCVR reduced study set-up timelines by 45% since it was brought in in October 2022.
When it's implemented, the unmodifiable financial appendix will contribute to setting-up studies faster. This means earlier access for patients to new and innovative treatments via research. It will also maximise opportunities for NHS organisations to recruit participants, enhancing the UK’s status as a global destination of choice for pharmaceutical research and unlocking opportunities for innovation and investment in our health service.
The UK Four Nations Contracting Leads Group (CLG) has been tasked with developing this financial appendix and will share a draft with NHS organisations and companies for comment in early July. Comments on the draft must be returned within two weeks so we can deliver this enhanced NCVR process from October. We encourage organisations to focus their comments on ‘red-line’ issues that would substantively affect their ability to deliver commercial contract research.
The call for comments will not be your only opportunity to give feedback. The CLG will continue to engage with NHS organisations and companies over the summer as it works through your comments to refine the financial appendix.
The call for comments from NHS organisations will be shared in early July, via HRA Now.
Please let relevant staff in your organisation know now so that you can meet this tight turnaround time.
|
