New Report from InSilicoUK, MHRA, PHG Foundation and the Royal Academy of Engineering: Journeys, experiences and best practices on computer modelled and simulated regulatory evidence.

Evidence generated by computer modelling and simulation methods (CM&S) have the potential to reduce, refine or even replace late-stage human testing, benefiting patient safety, the economy and sustainability. However, an identified barrier to their further scaling is uncertainty about regulator’s expectations and requirements for CM&S evidence. InSilicoUK, MHRA, PHG Foundation and the Royal Academy of Engineering, therefore co-convened a cross-regulator workshop, which brought together six regulators from different industries, to find out what barriers remain to increased regulatory acceptance of computer modelled and simulated evidence. 

On 1 December 2023, the workshop report, ‘Journeys, experiences and best practices on computer modelled and simulated regulatory evidence.’, was published. Prof Alex Frangi, Pankhurst Institute Director, is one of the leading authors.

This report reflects on the best practices, experiences and journeys of different regulators to explore what barriers remain and what next steps are needed to improve their regulatory acceptability. 

Key findings include:

• Consensus statement: Industrial, academic, and wider stakeholders’ uncertainty could be ameliorated by a high-level consensus statement by regulators signalling their openness towards CM&S generated evidence and its associated methods and undertaking health economic analysis in the medium-to-longer term to highlight their value and encourage further industry adoption.
• Public engagement:A top priority is exploring public acceptance and trust within regulatory pathways. Increased public engagement initiatives such as Citizen’s Jury events are needed to understand the public’s concerns, to ensure transparency and to earn trust.
• Development of generalisable principles:The development of good simulation practices and standards that support sound regulatory evidence with an emphasis on CM&S methods at both generalised and sector-specific levels are needed, and initial steps have been made by looking at adapting HM Treasury’s Aqua Book to keep pace with ever-changing technology in the AI and digital innovation space.
• International standard-setting and harmonisation:A need to look at developing mock or pre-submission processes for CM&S methods and at harmonising international standards in the medium to long term.
• Encouragement of future cross-sector discussions:There is a good, cross-sector appetite to continue collaborative efforts to maintain momentum generated by the July workshop and to use such dialogues to continue to learn from each other’s experiences, including with the addition of further stakeholders in future collaborative discussions.

Report Link: Redrup Hill, E., Mitchell, C., Myles, P., Branson, R., & Frangi, A.F. (2023). Cross-Regulator Workshop: Journeys, experiences and best practices on computer modelled and simulated regulatory evidence— Workshop Report. InSilicoUK Pro-Innovation Regulations Network. https://doi.org/10.5281/zenodo.10121103 [doi.org]