Published: 19 May 2023
Data from the first six months of the National Contract Value Review process shows that, on average, commercial studies are achieving study set-up milestones 95 days quicker.
The National Contract Value Review process is the UK’s standardised, national approach to costing and contracting for commercial contract research. It went live on 1 October 2022.
Quicker set-up times
Prior to implementation, the average time from initial costing submission by the sponsor, to the date of the first participant consenting to participate in the study, was 213 days. Following implementation, that set-up time has decreased to 118 days, a 44.6% reduction.
The end of March marked the six months period since implementation of the National Contract Value Review and has enabled initial analysis of the impact of the new process. In the six months before implementation it was taking an average of 7 months to complete costing and contracting as part of the 'set-up' activities for a clinical trial or study. For studies completing the new process that average figure is now 4 months.
“Revolutionary change”
Laura Bousfield, NIHR Head of Feasibility and Start Up said:
“The process is still bedding in and, understandably, this data reflects the experiences of quite a small cohort of studies. However, we are collecting more data every day, and what we are seeing is an extremely positive indication this new approach can shave a significant amount of time off what has historically been a lengthy part of the process for life science companies and Contract Research Organisations setting up multi-site studies.
“This revolutionary change in the way we work is possible because the UK is unique, our health and research ecosystem is unique, and we are global pioneers in this space. More and more countries are reaching out to understand how the UK costing and contracting model works. It is an exceptional achievement which will make the UK a more attractive prospect for global commercial clinical trials, which will ultimately give NHS patients access to more innovative treatments through participation in those trials.”
Minister of State for Health Will Quince said:
“This initial data is very promising and shows our commitment to improving speed and efficiency in clinical research – not only benefiting patients but also making the UK a more attractive place for research.
“This will ensure a better quality of life for patients both now and in the future as new treatments will be delivered faster, enabling the NHS to continue providing high-quality care.”
The analysis
The initial analysis is based on six studies that have completed all three defined phases of set-up activities with 12 sites. These were compared to 64 studies across 196 study sites in the six months before the new process started.
The data points used in the analysis are:
- The time it takes for the sponsor’s initial costing submission to be reviewed by the lead site and agreed by both parties (Study Resource Review)
- The time it takes for cost and contract negotiations with all sites. From the date the first site receives agreed costs, to the date of the last contract signature (Site Confirmation)
- The time it takes from Site Confirmation to first participant consented.
Analysis of the data will continue. Over 500 commercial studies have now entered into the National Contract Value Review process. This equates to approximately 83 studies per month. Over 220 studies have completed the Study Resource Review phase of the process and are now in the site contract negotiation phase. This involves over 2000 sites.
The average number of days taken to complete the Study Resource Review phase is currently 29 days. This is within the target 30 day target set by the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) for issuing their Combined Review response for a study submission. Enabling completion of approvals and costing activities in parallel will further improve the speed and efficiency of study set-up and contribute towards achieving the Government's 10 year vision for the Future of UK Clinical Research Delivery.
The National Contract Value Review (NCVR) programme, is a UK wide programme led in England by NHS England in partnership with DHSC, NIHR Clinical Research Network and the Health Research Authority and the Devolved Administrations. The NCVR focuses on agreeing the resources and price needed to set up research within an NHS provider. This work forms part of a broader common goal to ensure clinical research continues to thrive in the UK, for the benefit of patients and the public.
Find out more information about the National Contract Value Review.