Give us a snapshot of the context here – how does the UK sit in terms of a good place to run a clinical trial?

The UK is an ideal location for running complex oncology trials, supported by a unique infrastructure that enables world class research.

With the NHS providing access to a diverse patient population and rich health data, and recent regulatory reforms by the MHRA streamlining approvals, the UK offers an environment that fosters collaboration between academia, industry, and healthcare. This, alongside the strong framework in place to ensure clinical trial safety and ethics, makes it highly attractive for early phase trials, particularly in oncology and advanced therapies.

However, as highlighted in Lord O’Shaughnessy’s review in 2023, the UK has faced significant challenges in recent years in scaling its clinical trial capacity, streamlining regulatory processes, and ensuring the infrastructure can support faster, more efficient research delivery. And there are other reviews from the ABPI, Faculty of Pharmaceutical Medicine and the UKRD R&D Leaders in the NHS  which also point to slower trial initiation compared to countries like the US, Australia, and Spain.

This really underscores the need for continued improvement to maintain the UK’s global leadership in clinical research. The UKCRD programme has set an ambitious 150-day target for trial set-up to address these delays and restore global competitiveness.

So, if the UK’s position in running cancer trials has slipped in recent years, what do you think are the main reasons behind this, especially when it comes to setting up early-phase studies?

I think this has primarily been due to systemic and operational challenges that slow the initiation of studies.

Setting up early phase cancer trials is often disproportionately complex, involving multiple layers of regulatory approvals, contract negotiations and technical assurances for pharmacy and radiology. Of course, these processes are essential for patient safety, but they often introduce duplication and disproportionate regulatory burdens, creating inefficiencies that significantly delay trial start-up.

Despite the strong commitment and dedicated efforts of ECMC sites, initiating studies at the local level often takes longer than expected. These delays are driven by a combination of factors, including mounting pressures on the wider NHS, inefficiencies in study start-up processes, and the fact that research is still not fully embedded as a core clinical service within the NHS.

How has the ECMC Network been working with the regulators to improve things?

Other than all the previously mentioned work we do to improve processes, the ECMC Network has been amplifying the voice of investigators and patients.

Based on examples from across the network we compiled a detailed report for the Medicines and Healthcare products Regulatory Authority (MHRA) and the Department of Health and Social Care (DHSC). In it we highlight challenges in regulatory approval, including delays and, in some cases, exclusion of trials deemed safe and potentially beneficial to UK patients. We also outline concerns around timelines and decision-making transparency.

Following this, the network convened a high-level roundtable bringing together regulators, investigators, and other key stakeholders to address the root causes of trial rejections and delays. The goal was to co-develop solutions for a more efficient, transparent, and patient focused regulatory environment.

I’m really pleased to say that senior representatives from MHRA and DHSC were highly receptive and acknowledged the urgency of accelerating access to innovative treatments. There was also a commitment to work collaboratively with ECMCs to deliver these improvements swiftly and safely.

What were the key outputs from this meeting?

Regulators, investigators, and stakeholders aligned on the key barriers causing delays and rejections – such as overly complex regulatory pathways, inconsistent interpretation of safety requirements, and lack of proportionality in risk assessment. And it was incredibly positive to see the MHRA and DHSC commit to co-develop solutions with the ECMC Network, ensuring investigator and patient feedback informs future regulatory guidance.

Following the meeting, a clear roadmap emerged with both short-term and strategic steps A key priority is early engagement between researchers and regulators, ensuring that trials are designed with regulatory expectations in mind from the outset.

Improving patient and public involvement across MHRA processes is another cornerstone, ensuring that trial design and regulatory decisions reflect real world needs.

Transparency remains central to these reforms. MHRA has committed to clearer communication of timelines and metrics throughout the approval pathway, giving researchers greater certainty and accountability. Complementing this, the ECMC network is helping shape these improvements through its feedback and by fostering collaboration.

Perhaps the most influential voices at the table were those of patient representatives. They articulated the urgency of faster approvals in early-phase trials, where patients often have exhausted multiple lines of treatment and urgently need new options.

They also highlighted the need for a nuanced approach to risk, noting that those entering experimental studies often have a very different risk appetite compared to later-phase participants. Regulators unanimously agreed that embedding patient involvement earlier in the process alongside clinical expertise is essential to deliver faster, fairer, and more informed decisions.

Keeping momentum is now key, and we will continue to work with MHRA, DHSC, and other UK regulators to ensure these actions translate into meaningful improvements for patients and sponsors alike.