PS07: Assumptions, Modelling and Risks: Utilization of ICH-M15 beyond MIDD

Clinical trials and statistical analyses aim to inform decisions, but their credibility depends on the validity of underlying assumptions and the properties of the models used. Many innovative approaches improve efficiency by introducing assumptions that are difficult-or impossible-to test. While such assumptions may pose risks compared to conventional methods, they can be acceptable in specific contexts where benefits outweigh potential downsides. The draft ICH M15 Guideline, released in November 2024, provides a structured framework for assessing model risks and benefits in Model-Informed Drug Development (MIDD). Although focused on mechanistic models, its principles apply broadly to other methodologies, including Bayesian approaches, external data integration, and parametric longitudinal analyses. This session will explore systematic strategies for evaluating assumptions and model credibility under ICH M15 and related frameworks. We will discuss how these approaches enhance transparency, support cross-functional alignment, and inform decision-making for innovative modelling strategies in defined contexts of use. Session structure: 3 presentations + Panel discussion • Regulatory perspectives (TBC): Introduction to ICH-M15 and considerations on it's application for statistical modeling. • Industry representative: Experience on using ICH-M15 for MIDD projects • Industry representative: Application to statistical functions - How would ICH-M15 support discussion of innovative modelling approaches?