Clinical research is key to the vision of building a health and social care system fit for the future and to drive economic growth for this country, as laid out in the Health and Growth missions of the government. Research has already driven widespread improvements in care and outcomes for patients and the public and will continue to be a pivotal part of reform plans, together with supporting the wider life sciences sector via innovation and investment. 

Latest figures in the UK Clinical Research Delivery Performance Indicators Report (UK KPI) suggest most commercial studies still face delays in setting up once regulatory approvals are obtained. Two new commercial performance indicators were agreed in November 2023. These indicators have been carefully monitored throughout 2024 and despite limitations in the availability of site-level data, there is significant progress to be made to achieve the 90% target for each of these. The February 2025 UK KPI report stated: 

• 25% of studies opening to recruitment within 60 days of receiving HRA and HCRW Approval and equivalent

• 50% of studies recruit the first participant within 30 days of opening to recruitment

All four UK nations are fully committed to working with partners across the clinical delivery system via a newly recharged UK Clinical Research Delivery (UKCRD) programme to make the UK a world leader in clinical research and streamlining and reforming the set-up and delivery of clinical trials is a key priority for the programme.

To drive this, a new Study Set-Up Plan, co-led by the Department of Health and Social Care (DHSC) and NHS England on behalf of the four UK nations as part of the UKCRD programme will be delivered through UKCRD to rapidly address the delays affecting clinical research through digitalisation and reducing unnecessary bureaucracy. This plan will need the whole research community to act together to achieve the necessary improvements.

We are working at pace with system partners towards delivering key interventions across milestones in April through to June 2025 (and beyond). 

Study Set-Up Plan Workstreams

UKCRD partners worked closely with stakeholders across the clinical research system through extensive consultation and engagement to identify barriers contributing to study set-up delays. This informed and shaped the prioritisation of 4 key workstreams with emphasis on rapid deliverable actions to significantly improve study set-up times for all sponsored clinical research studies. These workstreams, which will be taken forward in partnership with the research community, are the initial steps to reduce negotiation and duplication of effort during study set-up to free up workforce capacity and drive efficiencies: 

1. Develop and mandate an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation and remove duplication of activity that can be done once on a per study basis during study set-up.

2. Remove duplication of activity that can be done once on a per study basis during study set-up by making it easier to understand and accept assurance from UK Pharmacy and Radiation Technical Assurances and Information Governance study-wide reviews. 

3. Enhance the granularity of study set-up performance data by including the site-level study set-up data behind the two key performance indicators (KPIs) currently published for commercial clinical study set-up.

4. Develop a single UK-wide costing and contracting model for non-commercial sponsored studies to reduce bureaucracy across the system.

These workstreams will be supported by a wider suite of complementary activities and designed to support longer-term developments to streamline and reform clinical trials.

Contact

UK Clinical Research Delivery

UKCRDprogramme@dhsc.gov.uk