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UK CTU Network publishes practical guidance to support international clinical trials

The UK Clinical Trials Units (CTU) Network has published new guidance to support researchers considering running clinical trials beyond the UK, offering practical advice for navigating the complexities of international collaboration.

The document takes the form of a “Things to Consider” guide, reflecting the wide variation in experiences across UK-based CTUs involved in international studies. It aims to provide a flexible and practical list of important areas for trial teams to bear in mind at the planning stage of multi-national research.

Supporting global trial delivery

Interest in conducting clinical trials across borders has grown significantly in recent years, driven by the need for larger, more diverse participant populations and the opportunity to address global health challenges. However, running trials outside the UK introduces a range of operational, regulatory, and cultural considerations.

The CTU Network highlights that experiences of international working differ considerably depending on the country, the trial design, and the timing of the work. As a result, producing rigid, one-size-fits-all guidance was seen as neither feasible nor helpful.

A practical approach

The new document draws on the shared experience of the UK CTU community to outline key areas that research teams should consider when planning international activity. These include costing and funding arrangements, understanding cultural and local contexts, navigating contracts and legal frameworks, and managing ethics and regulatory approvals across different jurisdictions.

The guidance also provides signposts to a range of existing resources developed by other organisations, helping researchers access more detailed or country-specific information where needed.

Developed through shared expertise

The guidance has been developed by a group of senior trialists from across the UK CTU Network, bringing together experience of designing and delivering trials in a wide range of international settings. This collaborative approach reflects the Network’s commitment to sharing knowledge and promoting best practice across registered CTUs, ensuring that collective learning benefits the wider trial community.

Learning from shared experience

A key message is the value of learning from colleagues. The CTU Network encourages researchers to connect with teams who have direct experience of working in particular countries, recognising the practical insights this can provide when navigating unfamiliar systems.

Researchers interested in speaking with colleagues from other CTUs can contact the Network, which will seek to connect them with individuals who have relevant international experience.

A living resource

By taking a principles-based approach, the Network hopes that the document will remain useful over time in a rapidly evolving landscape for global clinical research. Rather than attempting to keep pace with changing regulations and processes in every country, it provides a framework for thinking through key issues and making informed decisions.

The guidance is intended for anyone involved in trial design and delivery, including trial managers, statisticians, and chief investigators considering international expansion.

You can download the guidance here.