Advanced Therapy Clinical Trials Capability Framework
Introduction and background
Since establishment in 2018, the Advanced Therapy Treatment Centre (ATTC) network has been sharing knowledge and practice that has facilitated the NHS to deliver pioneering advanced therapies to more and more patients.
A current strategic initiative between the National Institute for Health and Care Research (NIHR), Innovate UK, Cell and Gene Therapy Catapult and the ATTC network aims to enhance the UK environment for Advanced Therapy Clinical Trials and to keep the UK as a location for advanced therapy research.
Training and education are critical NHS workforce enablers for the delivery of Advanced Therapy Trials to meet the needs of patients, trial sponsors and NHS organisations across the UK. The creation of a capabilities framework, as part of a national Advanced Therapy Clinical Trials training programme being developed by the ATTC network, will help address the existing challenge around lack of advance therapy-specific knowledge for trial delivery, research and support services workforces.
On behalf of the ATTC network, the Newcastle upon Tyne Hospitals NHS Foundation Trust has commissioned Skills for Health to develop an Advanced Therapy Clinical Trials Capabilities Framework to support this important work.
Purpose and scope
The delivery of the Advanced Therapy Clinical Trials Capabilities Framework will form an integral part of the national training programme being produced by the ATTC network.
The Framework will enable:
- The upskilling of the NHS Advanced Therapy Clinical Trials workforce nationally: by defining the knowledge and skills required by all clinical and non-clinical staff involved in advanced therapy trials, the Framework will improve the consistency of learning opportunities for NHS staff across the UK.
- More effective work with advanced therapy trial sponsors: roll out of the Framework in conjunction with the national training programme will allow clinical trial sites access to standardised training, enabling sponsors to focus on trial-specific training that will build on the comprehensive staff knowledge acquired through the national programme.
- Greater patient access to these innovative treatments: upskilling the workforce, thereby helping to improve the efficiency of trial delivery, will contribute to the UK’s attractiveness as a location to undertake commercial research, giving more patients the opportunity to participate in these trials.
Development of the framework
Development of the Framework is led by the Advanced Therapy Clinical Trials Expert Reference Group (the ‘ERG’) chaired by Uta Griesenbach, Professor of Molecular Medicine, Imperial College London and Fiona Thistlethwaite, Medical Oncology Consultant and iMatch Director, The Christie NHS Foundation Trust. Membership of the ERG comprises stakeholders and subject matter experts who will inform the design and content of the Framework.
The first stage of the project is focused on desk research to review existing source documents and working with the ERG to develop a draft Framework. The draft is anticipated to be ready for wider consultation in December 2025.
The Framework is due for completion by spring 2026.
Registration of Interest
Register here to receive updates about the development of the Advanced Therapy Clinical Trial Capability Framework and to receive notification of when it is ready for wider consultation.