A new national framework designed to support the standardisation and expansion of advanced therapy clinical trials in the United Kingdom (UK) has been launched.
The Advanced Therapy Clinical Trials Capability Framework has been produced jointly by the Advanced Therapy Treatment Centre (ATTC) network, the Cell and Gene Therapy Catapult, and Skills for Health.
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The new framework establishes a structured route map to assist sponsors in understanding service design, governance planning, workforce development and quality improvement in cell and gene therapy (CGT) trials in the UK.
It is planned 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 safe and effective practice and is intended to complement existing sponsor and regulatory governance arrangements rather than introduce new obligations.
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 the 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.”
The initiative follows similar advancements undertaken in the US advanced therapies sector. In September 2025, the US Food and Drug Administration (FDA) launched new guidance for CGTs, setting out six alternative trial designs that sponsors can utilise to assist with the development of products.
For years, sponsors have been utilising innovative trial designs in CGT. Analysis by Clinical Trials Arena in May 2024, using GlobalData’s Pharmaceutical Intelligence Center, found that the single-group assignment trial design was by far the most used approach for CGTs. The type of trial should be determined by the patient population and the indication.
According to GlobalData, parent company of Clinical Trials Arena, the global CGT market was estimated to be worth $5.88bn in 2023, and is set to grow at a CAGR of more than 43% from 2023 to 2030.
This new framework also launches at a time when it is predicted that the UK biotech sector could be bound for recovery, according to a report by the UK’s BioIndustry Association (BIA). In the BIA’s Q1 2026 biotech financing report, the trade body noted that the total equity financing raised by UK companies was £552m ($746m) – marking a 18% uptick from the £466m ($632m) raised in Q4 2025.
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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