A new framework designed to support the standardisation and expansion of advanced therapy clinical trials has launched in the UK.
The Advanced Therapy Clinical Trials Capability Framework, produced jointly by the Advanced Therapy Treatment Centre (ATTC) network, the Cell and Gene Therapy Catapult and Skills for Health, provides a shared strategic resource to support decision making across advanced therapy clinical trials services.
As a rapidly evolving field in healthcare, the new framework establishes a structured route map to enable coordinated knowledge and learning planning, service design, governance planning, workforce development and quality improvement activities across the sector.
Funded by the National Institute for Health and Care Research (NIHR) and Innovate UK, the framework builds on the ATTC network’s programme of activity to improve advanced therapy clinical trial readiness and help ensure that UK maintains its position as a globally attractive destination for advanced therapy clinical research.
Matthew Durdy, chief executive of the Cell and Gene Therapy Catapult, said: “Advanced therapies treat the root cause of a range of diseases and disorders, including cancer, sickle cell disease and spinal muscular atrophy. The creation of an advanced therapy capability framework, as part of a national advanced therapy medicinal product training and education programme, will help address the existing challenge around a lack of therapy specific knowledge across trial delivery, research and support service workforces.
“Having this framework in place represents a significant step towards expanding the workforce dedicated to advanced therapy clinical trials and scaling up the delivery of cell and gene therapy treatments across the NHS.”
Fiona Thistlethwaite, medical oncology consultant and iMATCH director at The Christie, said: “As a principal investigator delivering advanced therapy clinical trials, I see first-hand how essential training and education are as NHS workforce enablers. They underpin our ability to translate innovation safely and effectively into patient benefit.
“This framework provides a much-needed, standardised reference point to support the training and development of the future advanced therapies workforce, ensuring we can meet the needs of patients, trial sponsors and NHS organisations across the UK.”
Vicky Yearsley, principal consultant – Education and Standards at Skills for Health, said: “This framework is intended to be a platform for dialogue that supports the planning and delivery of advanced therapy clinical trials into the future.
“It offers a structured way to consider the role relevant capabilities, responsibilities and development needs of individuals and provides a shared language to explore capability dependencies, supporting multidisciplinary coordination and governance.”
The Advanced Therapy Clinical Trials Capability Framework is organised around the typical lifecycle of advanced therapy medicinal products clinical trial activity and comprises five interconnected dimensions: initial sponsor engagement, trial set-up, trial delivery, trial close-out and long-term follow-up. It also supports understanding of safe and effective practice and is intended to complement existing sponsor and regulatory governance arrangements rather than introduce new obligations.