The evolution of statistical analysis framework in clinical trials:taking the development of GLP-1 drugs as an example

主讲人：李莉

美国佛罗里达大学生物统计学博士，现任信达生物制药公司生物统计与信息部生物统计总监。

曾供职于法国赛诺菲制药公司，中国百济神州生物制药公司，美国耶鲁大学成果研究与评价中心。在制药行业及临床科研机构工作17余年，参与制药公司及美国国家肿瘤协会发起或资助的近百项临床研究，包括实体肿瘤、血液肿瘤、糖尿病，心脑血管、肾病、多发硬化症、眼病、自免类等多疾病领域。

发表于Statistics in Medicine, New England Journal of Medicine, Nature Communications等统计学方法论及科研学术国际论文20+篇。

1  报告信息

时间 

2025年10月30日（周四）

14:00-15:00

地点 

中国人民大学通州校区

商学楼109

2  报告摘要

In pharmaceutical industry, the statistical analysis methods and modeling that are required by health authorities or preferred by sponsors are constantly evolving, and this is particularly evident in the development of GLP-1 drugs. The evolution is manifested in aspects such as the continuous optimization of trial design, the continuous enrichment of data analysis methods, and the increasing popularity of applying estimand framework to answer the clinical question of interest and smooth interaction between health authorities and sponsors in respect of what to be estimated and how to interpret the study results.

In this report, I will walk you through the development of several GLP-1 drugs so we can take a glimpse of how the statistical analysis-related aspects are evolving in a time span of 15 years or so. Lastly, we could talk about some small topics like new trend in modern clinical trials, what could be potential research topics and how statisticians should be advancing with the times in the era of AI.