Study Set-Up

Study Set-Up Plan

The Study Set-Up Plan’s aims are to streamline and reform the set-up and delivery of clinical trials through digitalisation and reduction of unnecessary bureaucracy freeing up workforce capacity to deliver clinical trials.

This plan is co-led by the Department of Health and Social Care (DHSC) and NHS England, will be delivered through UKCRD – a cross-sector programme of work that brings together key stakeholders to achieve the common aim to offer a world-leading environment for life sciences to undertake research across the UK.

Workstreams

The Study Set-Up Plan will deliver 4 key workstreams with emphasis on rapid deliverable actions to significantly improve study set-up times and to take initial steps to reduce negotiation and duplication of effort during study-set up to free up workforce capacity: 

• Develop and mandate an efficient streamlined UK-standardised commercial contracting process. 

• Remove duplication of activity that can be done once on a per study basis during study set-up with Pharmacy and Radiology Health Research Authority (HRA) Technical Assurances and introducing new information to reduce queries to HRA central reviewers for Information Governance. 

• Enhance the granularity of study set performance data by including the site-level study set-up data behind the two key performance indicators currently published for commercial trial study set-up.  

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

The power of partnership

DHSC established the Study Set-Up as a key priority for system partners across the sector to deliver, ensuring the UK’s clinical research ecosystem can thrive. As a result, UKCRD has worked closely with stakeholders across the clinical research system through intensive consultation and engagement to identify barriers contributing to study set-up delays. Feedback from industry representatives and UK R&D has also shaped the prioritisation of the Study Set-Up Plan’s actions. 

DHSC would like to thank system partners for all of their thoughtful contributions: National Institute for Health and Care Research (NIHR), NHS England (NHSE), Health Research Authority (HRA), Devolved Administrations Health Departments, the UK Clinical Research Delivery (UKCRD) Programme Committees, UK R&D and The Association of the British Pharmaceutical Industry (ABPI) fora to determine the root causes of set-up and also incorporating the success of the UK Vaccine Innovation Pathway (VIP) accelerated delivery pilot learnings.

Measuring Success

No single action will resolve delays in study set-up, these workstreams will be supported by a wider suite of complementary activities. The work of the Study Set-Up Plan will be looking closely at both commercial and non-commercial studies. Set-up activities happen in parallel and to make the biggest impact we must drive efficiencies and improvements to the whole process across the portfolio.

The Study Set-Up plan is an ongoing priority for UKCRD, and we will continuously measure the progress and impact of the plan’s workstreams. As with all of UKCRD’s performance indicators, delivery partners know how important it is to transparently share the latest progress, all of which can be found in UKCRD’s monthly UK Clinical Research Update.