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Virtual

Mar 29, 2023 10:00 AM - Mar 31, 2023 4:15 PM

(US Eastern Standard Time)

DIA/FDA Biostatistics Industry and Regulator Forum

Join us virtually from the comfort of your home/office March 29-31 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 1: The Critical Role of Covariates in Clinical Trial Design and Analysis

Session Chair(s)

Dalong Patrick Huang, PhD

Dalong Patrick Huang, PhD

Lead Mathematical Statistician, CDER

FDA, United States

Li  Wang, PhD

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In May 2021, the US Food and Drug Administration (FDA) released a revised draft guidance for industry on “Adjustment for Covariates in Randomized Clinical Trials for Drugs and Biological Products”, which highlighted the critical role of covariates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)

Daniel B. Rubin, PhD

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

Hongjian  Zhu, PhD

Handling Covariates in the Analysis of Covariate Adaptive Randomized Clinical Trials

Hongjian Zhu, PhD

AbbVie Inc., United States

Director, Statistical Innovation Group

David  Miller

AI-Generated Digital Twins Power the RCTs of the Future

David Miller

UNLEARN, United States

Chief Science Officer

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