时 间：2025年3月20日 16:00 - 17:00
报告人：Mouna Akacha Novartis Pharma AG
地 点：普陀校区理科大楼A302
主持人：徐进 华东师范大学教授
摘 要：
Causal thinking and inference methods are increasingly important in global drug development, notably influenced by recent regulatory guidelines like the ICH E9(R1) guideline on estimands and sensitivity analysis (2019) and the FDA draft guideline on covariate adjustment (2024). These guidelines draw from foundational causal inference concepts – such as potential outcomes, principal stratification, non-collapsibility, and standardization – highlighting the paradigm shift towards causal thinking in drug development practices. This presentation leverages these significant advancements to explore how causal inference offers a robust mathematical framework and tools to formally establish causal relationships between key factors like drug interventions and their effects. Through examples, we underscore the critical importance and implications of deploying causal inference methodologies in global drug development. Specifically, we delve into the complex dynamics of chronic heart failure, wherein patients face recurrent hospitalizations alongside increased mortality risks. Addressing challenges in interpreting treatment effects when death interrupts further events, we explore various statistical analysis approaches and advocate for the explicit delineation of estimands with causal interpretations, aligning with principles outlined in the causal inference literature and the ICH E9(R1) guideline. By scrutinizing estimands for events terminated by death through a causal lens and evaluating the implications of common statistical analyses, we aim to illuminate the power and relevance of causal inference in shaping the future of drug development research methodologies.
报告人简介：
Mouna Akacha is the Global Group Head of the Statistical Methodology Group of Novartis Pharma AG, based in Basel, Switzerland. Mouna has a wide range of research interests including topics on estimands, missing data, causal inference, longitudinal data and recurrent event data. Before joining Novartis, Mouna studied mathematics at the University of Oldenburg in Germany and holds a PhD in statistics from the University of Warwick in the UK.