Advanced clinical therapy trial framework launched
A new national framework aimed at supporting the expansion and standardisation of advanced therapy clinical trials across the UK has been launched 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 as a strategic resource to support service planning, workforce development, governance and quality improvement activities linked to advanced therapy medicinal product (ATMP) trials.
Funded by the National Institute for Health and Care Research and Innovate UK, the framework builds on the ATTC network’s wider programme to improve readiness for advanced therapy clinical trials and reinforce the UK’s position as a destination for cell and gene therapy research.
The framework is structured around five key stages of advanced therapy trial activity: sponsor engagement, trial set-up, trial delivery, trial close-out and long-term follow-up. According to the organisations involved, it is intended to support safe and effective practice while complementing existing regulatory and sponsor governance systems rather than introducing additional obligations.
Matthew Durdy (pictured left), chief executive of the Cell and Gene Therapy Catapult, said advanced therapies are increasingly being developed to target the underlying causes of diseases including cancer, sickle cell disease and spinal muscular atrophy.
He said the framework would help address ongoing challenges linked to therapy-specific knowledge gaps across research, clinical trial delivery and support service teams.
The organisations behind the initiative say the framework is intended to create a shared language for capability planning and multidisciplinary coordination across NHS organisations and research partners.
It also aims to provide a more structured approach to identifying workforce responsibilities, training requirements and service dependencies as advanced therapy trials continue to grow in complexity and scale.
Fiona Thistlethwaite (pictured right), medical oncology consultant and iMATCH Director at The Christie NHS Foundation Trust, said workforce training and education were critical to translating advanced therapy innovation into patient benefit.
“This framework provides a much-needed, standardised reference point to support the training and development of the future advanced therapies workforce,” she said.
Vicky Yearsley, principal consultant - education and standards at Skills for Health, described the framework as “a platform for dialogue” to support future planning and delivery of advanced therapy clinical trials.
According to the project partners, the initiative represents a further step towards scaling up delivery of cell and gene therapies across the NHS while supporting increasingly complex clinical trial infrastructure requirements.
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