Good Practice for Biomarker discovery and development in assessing treatment effect heterogeneity in new drug development

Xin Huang Co-Author
AbbVie Inc.
 
Xin Huang Speaker
AbbVie Inc.
 
Monday, Aug 4: 9:35 AM - 9:55 AM
Topic-Contributed Paper Session 
Music City Center 
In drug development, the exploration of treatment effect heterogeneity (TEH) within the treated population is important for advancing precision medicine. Drugs may exhibit varying effects across disease subtypes and patient subgroups, often identified through biomarker signatures. Investigating TEH is a continuous scientific process that needs interdisciplinary collaboration throughout the drug development pipeline. Statisticians play a critical leadership role in this process, ensuring robust analysis and interpretation for the study team to make informed decisions. This talk will explore best practices for statisticians in collaborating with interdisciplinary teams to identify TEH in precision drug development.

Keywords

treatment effect heterogeneity

biomarker

predictive biomarker

prognostic biomarker

biomarker signatures

subgroup identification