Bringing the early-phase cancer research community together to tackle shared challenges

Behind the Early Phase Regulatory Forum and Trial Operational Delivery Forum is a growing programme of work designed to increase efficiency and innovation within early-phase cancer research in the UK.

These forums were established by our experimental cancer medicine centres (ECMC) network’s programme office. Both forums draw on the collective experience of clinical and operational experts within our network, Cancer Research UK, UK regulators, government, industry and patient advocates. Their role extends beyond discussion forums touching on shared challenges. Members contribute to wider national improvement initiatives, provide evidence based case studies to highlight barriers and help develop practical improvements to the regulatory and operational landscape.

While the Trial Operational Delivery Forum focuses on the operational aspects of set-up and delivery of trials, the Early Phase Regulatory Forum examines regulatory challenges that can influence whether innovative studies are placed in the UK. Together, they aim to create a more efficient and attractive environment for early-phase oncology research and help patients access novel treatments sooner.

The Trial Operational Delivery Forum brings together Centre Business Leads and operational experts from our adult and paediatric centres. By comparing experiences across the network, the forum can identify common priorities and ensure that the early-phase perspective informs national initiatives.

This has included contributing to the National Contract Value Review process for early-phase oncology and advanced therapy medicinal product (ATMP) trials. The forum’s collective expertise helped highlight the specific requirements of complex studies, inform an adapted costing approach and ensure that guidance reflects how these trials are delivered in practice.

The Trial Operational Delivery Forum also supported work with the Health Research Authority to explore how processes involving pharmacy and imaging services can become more efficient. Insights from across the network highlighted where duplication, inconsistent requirements and local variation can delay study set-up, as well as where there are opportunities to improve clarity and consistency.

The forum is currently considering the wider pathway for early-phase trials, including clearer roles and responsibilities, more consistent processes, an effective site delivery model and better access to operational information and expertise. Through these activities, the Trial Operational Delivery Forum provides a strong national voice for people delivering early-phase trials and turns shared challenges into opportunities for practical improvement.

The Early Phase Regulatory Forum brings together experts within the ECMC network, Cancer Research UK, regulators, government, industry and patient advocates to improve efficiency and address regulatory challenges that can affect whether innovative early-phase oncology trials come to the UK.

Through engagement with the ECMC network and industry partners, the forum identified recurring challenges relating to modifications, bureaucracy, conditional approvals, expertise, non-OECD data, and in vitro diagnostic regulation. Real trial examples showed how these issues can cause delays, create uncertainty and lead sponsors to place studies elsewhere.

When this happens, the impact extends beyond processes and timelines. The UK risks becoming less competitive internationally and patients may lose opportunities to access promising treatments when few established options remain.

The forum is helping turn this evidence into action. Following concerns about the acceptance of preclinical data generated in non-OECD countries, such as China, regulators established a dedicated working group to examine the issue. Positive developments have emerged in discussions around how evidence generated by selected international laboratories may be considered by regulators, helping to address a key challenge raised through the forum.

ECMC clinical leads along with regulatory experts at Cancer Research UK's Centre for Drug Development are also contributing to work to update regulatory guidance. This helps ensure that the distinct characteristics of early-phase oncology trials are understood and appropriately represented.

Alongside this, the forum is looking to collaborate on an early regulatory advice pilot with regulators working with industry partners to identify a suitable study. The proposed approach will involve clinical experts and patient advocates, helping identify potential issues earlier and ensuring specialist and patient perspectives inform regulatory decisions from the outset.

No single organisation can resolve every challenge affecting early-phase research. However, through these forums, the ECMC network shows how individual experiences can be brought together as evidence and used to shape national improvements.

As the forums develop, their focus will remain on creating a more efficient, and responsive research environment, supporting the UK to attract innovative trials and helping new treatments reach patients sooner.