News & Media

Strengthening Quality and Capacity in UK Clinical Trials

The UK Clinical Research Collaboration (UKCRC) Clinical Trials Unit (CTU) Network was created in 2007 in response to a shared recognition among researchers and funders that the UK needed greater capacity and consistency in the design and delivery of high‑quality academic clinical trials. Established alongside the growth of the National Institute for Health and Care Research (NIHR), the Network provides a coordinated, nationally accessible system that connects CTUs with funders, regulators and other key stakeholders, while supporting best practice through shared expertise and independent review.

Central to this mission is the Network’s registration process. Registration serves as a visible and trusted benchmark of quality for non‑commercial academic clinical trials, enabling funders, collaborators and participants to identify CTUs with the expertise, infrastructure and systems required to deliver robust and ethical research. In our current rapidly evolving trials landscape, clear and credible standards remain as essential as ever.

This review placed strong emphasis on engagement with a broad range of stakeholders, including CTU staff, research participants, funders and regulators. Their input was vital in testing whether the existing criteria continued to reflect quality and competence, and in identifying opportunities to future‑proof the process.

Stakeholders were invited to review how clear and effective the current criteria are, covering areas such as portfolio, staff expertise, infrastructure, quality assurance, information systems, research strategy, national standards (e.g. PPI&E), and statistics. Patient and public contributors took part in several workshops, allowing more detailed feedback to be gathered. Views were also sought on renewal timelines for existing members and on the approach to open calls for new CTUs. All feedback was considered by the Criteria Review Group, set up to oversee the process, as well as by the Executive Group and the independent International Registration Review Committee.

Overall, respondents supported the current approach, with no major structural changes recommended. However, several thoughtful refinements were agreed. These included clarifying expectations around the completion and publication of randomised controlled trials, broadening the way CTUs can evidence contribution beyond named authorship, strengthening PPI&E criteria, introducing an Equality, Diversity and Inclusion element, updating language in the Information Systems and Statistics sections to reflect current practice, and making the frequency of open calls clearer and more predictable.

This review has reaffirmed the strength of the existing registration framework and highlighted its continued value. By maintaining a clear marker of excellence across all stages of non‑commercial trials, the CTU Network continues to play a vital role in supporting high‑quality research and safeguarding the UK’s global reputation for clinical trials excellence.

Of the registration process, Otavio Berwanger, Chair of the International Registration Review Committee said:

“Being part of the UK Registered Clinical Trials Unit (CTUs) Network isn’t just about recognition; it genuinely strengthens how CTUs design and deliver trials. The registration criteria help ensure the right expertise, processes, and governance are in place to run studies that are both robust and reliable, ultimately improving the quality of the evidence we generate.”

To view the updated criteria, and the associated guidance, please click here.