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Lei Nie

FDA



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Zhiwei Zhang

FDA/CDRH



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Jialu Zhang

FDA



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254 – Early-Phase Clinical Trials: Setting the Stage for Success

Randomization Does Not Prevent Bias When We Assess Treatment by Covariate Interaction

Sponsor: Biopharmaceutical Section
Keywords: Bias;, Treatment by covariate interaction;, subgroup analysis

Lei Nie

FDA

Zhiwei Zhang

FDA/CDRH

Jialu Zhang

FDA

Inference for the overall treatment effect resulted from a randomized clinical trial has the best credibility. In a traditional paradigm, where a clinical trial is primarily designed to answer a single question regarding the average (overall) treatment effect, randomization effectively prevents systematic confounding and bias when we assess the overall treatment effect. In an increasingly important new paradigm, inference of treatment heterogeneity is key to comparative effectiveness. In this new paradigm, randomization does not prevent systematic bias when we assess treatment by covariate interaction. Through a case study, this paper explains how this phenomenon occurs and examines whether and how this problem could be solved.

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