UK introduces framework for advanced therapy trials
The UK is set to introduce a national framework to boost advanced therapy clinical trials.
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.
The new framework provides 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 promises to build on progress already made by ATTC to ensure the UK maintains its position as a globally attractive destination for advanced therapy clinical research.
“Advanced therapies treat the root cause of a range of diseases and disorders, including cancer, sickle cell disease and spinal muscular atrophy,” said Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult.
“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.”
“This framework is intended to be a platform for dialogue that supports the planning and delivery of advanced therapy clinical trials into the future,” added Vicky Yearsley, Principal Consultant, Education and Standards at Skills for Health.
“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.”