Good Practice for Biomarker discovery and development in assessing treatment effect heterogeneity in new drug development
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.
treatment effect heterogeneity
biomarker
predictive biomarker
prognostic biomarker
biomarker signatures
subgroup identification
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