Advanced Therapy Clinical Trials Capability Framework
Capabilities Frameworks
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, helping to meet the needs of patients, trial sponsors and NHS organisations across the UK. As part of the development of the national Advanced Therapy Clinical Trials training programme, Newcastle upon Tyne Hospitals NHS Foundation Trust, on behalf of the ATTC network, commissioned Skills for Health to develop the Advanced Therapy Clinical Trials Capability Framework.
The newly created framework will help address existing gaps in advanced therapy-specific knowledge across trial delivery, research and support services workforces.
Purpose and scope
The Advanced Therapy Clinical Trials Capability 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 capabilities 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 was 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 comprised stakeholders and subject matter experts who informed the design and content of the Framework.