Question: Could you explain how you approach the development of adaptive trial designs, and how you incorporate predictive modeling and simulations to forecast future outcomes or adapt treatment allocations in real-time, while maintaining ethical considerations and regulatory compliance?

William Tolmie answered on 27 May 2025:

This is a big and complex question, but I’ll do my best to explain, Owen.

The trials we run in our hospital are generally limited to simple, hands-on use of a device before purchase. Typically, this involves nurses, clinical scientists, or doctors trying the device with patients. Each trial is carefully designed and risk assessed by our team, following the relevant standards and regulations — specifically, ISO 13485, the Medical Device Regulations, and the General Data Protection Regulation (GDPR), which governs how we handle personal data.

We also assess how the device would affect current patient treatment pathways, considering both the potential benefits and any drawbacks of new features or changes in function. By taking a structured, evidence-based approach to evaluating risk and benefit, we aim to put patients first and improve diagnostic and therapeutic outcomes.

Modelling was covered during our university training and is used in some emergency departments to understand and improve patient flow. Simulation is also routinely used in radiotherapy for treatment planning and targeting cancerous tissue. However, I don’t carry out modelling or simulation in our Trust, as the number of variables involved makes it difficult to produce reliable or actionable results.