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Session 1: The Critical Role of Covariates in Clinical Trial Design and Analysis
Session Chair(s)
Dalong Patrick Huang, PhD
Lead Mathematical Statistician, CDER
FDA, United States
Li Wang, PhD
Senior Director, Head of Statistical Innovation
AbbVie , United States
In May 2021, the US Food and Drug Administration (FDA) released a revised draft guidance for industry on “Adjustment for Covariates in Randomized Clinical Trials for Drugs and Biological Products”, which highlighted the critical role of covariates in clinical development. This guidance provides recommendations for the use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to both superiority trials and noninferiority trials. The main focus of the guidance is on the use of prognostic baseline factors to improve precision for estimating treatment effects. Leveraging and adjusting covariates appropriately in clinical trial design and analysis can make clinical development much more efficient. In response to the FDA guidance on covariate adjustment, this session invites experts from regulatory, academia and industry to talk about various perspectives on the topic and to share the most recent innovative methodology development and cases in practice.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain the FDA guidance on covariate adjustmen
- Discuss the critical role of covariates adjustment in clinical trial development
- Identify the most recent methodology development
- Apply use cases leveraging covariates in clinical trial design and analysis to increase the efficiency of clinical development
Speaker(s)
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
Daniel B. Rubin, PhD
FDA, United States
Statistician, Office of Translational Science, CDER
Handling Covariates in the Analysis of Covariate Adaptive Randomized Clinical Trials
Hongjian Zhu, PhD
AbbVie Inc., United States
Director, Statistical Innovation Group
AI-Generated Digital Twins Power the RCTs of the Future
David Miller
UNLEARN, United States
Chief Science Officer
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