The Challenge 

Following the publication of Commercial clinical trials in the UK: the Lord O’Shaughnessy review in May 2023, the UK Government committed to reducing clinical trial set up times and introduced new performance metrics for clinical trial activity. Advanced Therapy (ATMP) trials are often complex with a lengthy onboarding time and can require completion of additional trial set-up processes such as approvals from local Genetically Modified Safety Committees.  

Since April 2025, the UK government has been committed to reducing the clinical trial set up time from over 250 to 150 days by March 2026*. 

*DHSC Policy statement sets out details of the150 days metric (published 2 Oct 2025). 

 

The Solution 

NHS Tayside, a funded partner of the ATTC Network, has implemented a range of improvements to accelerate the review process and so reduce the onboarding time for ATMP trials and meet national targets. The streamlined model is described below. 

 

Feasibility 

  • Clinical Research Facilitators, responsible for feasibility and study start up, attend Site Selection Visits (SSV) and complete an internal Site Information Sheet detailing the study requirements.  
  • For complex studies, including ATMP trials, the Tayside NHS Research & Development (R&D) reviewers, responsible for governance, budget, and contract negotiations also attend the SSV and gathers information, asks questions, and builds relationships with key stakeholders. 

 

Early Engagement for Faster Approvals 

  • Once Tayside is confirmed as a trial site, Tayside NHS R&D reviewers send an introductory email to the sponsor or CRO which includes a concise set of standard questions designed to accelerate the review process  
  • If the study team intends Tayside to be the first site to open or recruit, this priority is flagged early. 
  • To maintain momentum, an early ‘kick-off’ meeting with the study team and sponsor resolves queries, reduces email traffic, and strengthens communication channels. 
  • Sponsors are encouraged to hold post site selection calls with the study teams and R&D to resolve queries quickly, reduce email traffic, and build strong communication links 

 

Parallel Local Review 

  • A comprehensive local review by a team of experienced, multiskilled reviewers runs in parallel with the regulatory and ethics combined review.  
  • Adequate reviewer resource ensures continuity and prevents time lost during periods of absence.  

 

Contracts and Finance 

  • The final UK study budget is reviewed locally in parallel with the regulatory and local reviews.   
  • Sign-off authority is delegated to the Senior R&D Manager. 

 

Timeline Management 

  • Sponsor timelines (including the recruitment window) are agreed and revisited frequently, timelines are monitored daily using the national clinical research reporting capability, NHS Research Scotland (NRS) Power BI reports, with review activities re-prioritised accordingly. 
  • Electronic signatures are used to speed the approvals process. 
  • An internal tracker is created to log proposed studies and track performance, and emerging issues are escalated early to the commercial team lead. 

 

 Governance and Information 

  • Top-level information governance (IG) review is delegated to R&D colleagues. 
  • The Tayside Senior R&D Manager and R&D Director can provide valuable clinical input, where required. 
  • Defined roles, delegated authority, and escalation routes are established early. 

 

Advanced Therapy Governance 

  • Biological Safety Officers (BSOs) are embedded within the commercial and oncology teams; the Advanced Therapy Genetically Modified Committee (ATGMC) can include two BSOs. The additional BSO resource provides back up in periods of absence. 

 

The Results 

Over the past year, the Tayside model has delivered measurable improvements in start-up efficiency, with sustained reductions in review timelines. Through having dedicated roles at the early stages of feasibility and site selection NHS Tayside have created a point of contact for Sponsors and Contract Research Organisation (CROs) 

  • The local combined review process turnaround times have reduced from 73 days in 2023/24 to 53 days in 2024/25 (Calculated from sponsor submission of regulatory documents and to completion of the UK Study Wide Review).  
  • While full data for 2025/26 will not be available until end of March 2026, current performance monitoring indicates a further significant reduction in turnaround times.  
  • Faster timelines maximise the time available for study teams to recruit participants, supporting researchers in meeting recruitment targets. Faster approvals mean participants can access potentially beneficial treatments sooner. 

 

Wider Impact 

Adoption Through the ATTC Network – Strengthening the NHS 

This model could be shared and adopted by other Health Boards and Trusts and so benefit the wider research community.  

By improving start up times, more sites could have the opportunity to participate in research, enabling patients to have access to innovative treatments and trials locally. As experimental medicinal products and devices are supplied by commercial companies at no cost to the NHS, commercial research delivers significant cost savings to the health service by delivering no-cost therapeutic options to patients who may otherwise require on-going centrally funded treatments.   

Faster trial set-up enables more studies to open each year, increasing research capacity and creating additional opportunities for NHS staff to participate in high-quality research. This contributes to staff development, recruitment, and retention across the UK, and increases patient opportunity to receive life-changing and life-saving treatments.