The Challenge:

Complex Advanced Therapy Medicinal Product (ATMP) clinical trials increasingly require expertise that is distributed across specialties, services and NHS organisations. For a Chimeric Antigen Receptor T-cell (CAR T) autoimmune trial, two iMATCH partners – Northern Care Alliance NHS Foundation Trust (NCA) and Manchester University NHS Foundation Trust (MFT) – needed to deliver one participant pathway across clinical specialties and NHS organisations, because the required expertise was not located within a single Trust.

The protocol required NCA to identify, consent and recruit participants; MFT to deliver specialist CAR T-cell treatment and acute monitoring; and participants to return to NCA for ongoing follow-up. This created a shared care model with practical challenges around handover, communication, safety monitoring, data capture, escalation and continuity of participant care.

A key challenge was to give the sponsor confidence that trial delivery could be managed safely, consistently and with accountability across organisational boundaries.

The Solution:

The iMATCH partners developed a shared care approach that set out how trial activities would be coordinated across NCA and MFT. The model defined the participant pathway from recruitment through to follow-up and ongoing care. It also clarified handover points, information sharing, escalation routes and responsibility transfer between the two organisations.

Supporting templates and process materials were created to provide a practical framework for coordinating set-up activity, documenting responsibilities, managing operational oversight and to maintain consistent communication across the shared care pathway.

The approach also highlighted the importance of contractual arrangements and Principal Investigator oversight when delivering interventional advanced therapy research across more than one trial location. By aligning the model with Health Research Authority (HRA) and IRAS guidance, the partners clarified governance requirements with the sponsor and strengthened confidence in the delivery model.

Learnings from NCA and MFT were captured through a local working group, which produced practical guidance, a process flowchart and supporting templates covering key steps from pre-set-up through to close-out.

The Results:

• Cross-Trust trial set-up enabled

NCA and MFT delivered recruitment, specialist CAR T-cell treatment and follow-up through one shared participant pathway

• Governance and contracting strengthened

NCVR, documentation, biosafety governance, contracting and oversight requirements were clarified across both NHS organisations

• First European recruitment achieved

Early alignment between clinical, research, governance and sponsor teams supported effective feasibility and set-up and delivery

• Participant safety supported

Responsibilities, handover points, communication routes and escalation processes were defined across recruitment, treatment and follow-up, reducing ambiguity and supporting patient safety

• Supported wider ATMP trial delivery

The same model has subsequently been used to successfully set up further ATMP clinical trials, showing its scalability beyond the original study

• Reusable model and standardised resources produced

The collaborative approach generated guidance, a process flowchart, participant pathway, templates and materials to support a structured approach for future adoption of shared care ATMP trials by other NHS organisations

Wider Impact:

The ATTC network has identified the establishment of shared care arrangements as a key challenge in ATMP trial set-up, highlighting it as a broader barrier across ATMP clinical trials.

Learning from the development of this local guidance was used to inform a wider ATTC network consultation, enabling experience from iMATCH NHS organisations to be tested, broadened and strengthened through input from subject matter experts and delivery teams across the network.

This collaborative review translated local practice into UK-wide guidance that can be adapted by other organisations planning shared care arrangements for complex advanced therapy studies across disciplines, services or NHS organisations.

The UK-wide guidance, Establishing shared care Advanced Therapy Medicinal Product (ATMP) trials, within or across NHS Trusts & Health Boards, is available through the ATTC network NHS Readiness Toolkit. By creating a reusable resource, the work has contributed to the ATTC network’s wider aim of accelerating safe and efficient advanced therapy trial delivery across the UK.

The shared care model has already supported further ATMP clinical trial set-up by NCA and MFT, demonstrating lasting system value for more consistent, scalable and participant-centred delivery of advanced therapy research.