A new national framework has been introduced to strengthen and standardise advanced therapy clinical trials across the UK. Developed collaboratively by the Advanced Therapy Treatment Centre (ATTC) network, the Cell and Gene Therapy Catapult, and Skills for Health, the Advanced Therapy Clinical Trials Capability Framework is designed to support the growing demand for specialist skills, governance, and infrastructure in this rapidly evolving area of healthcare.
Funded by the National Institute for Health and Care Research (NIHR) and Innovate UK, the framework aims to improve readiness for advanced therapy clinical trials while helping the UK remain an attractive destination for innovative medical research. It provides a structured approach for workforce development, service planning, knowledge sharing, and quality improvement across NHS organisations and research teams.
Advanced therapies, including cell and gene therapies, are increasingly being used to treat conditions such as cancer, sickle cell disease, and spinal muscular atrophy. Industry leaders say the framework will help address gaps in specialist training and support the expansion of the workforce needed to deliver these complex treatments safely and effectively.
The framework is organised around five key stages of clinical trial activity: sponsor engagement, trial set-up, trial delivery, trial close-out, and long-term follow-up. It is intended to complement existing regulatory and sponsor requirements while encouraging stronger multidisciplinary collaboration across the sector.
