FDA Guidance Adjusting for Covariates in Randomized Clinical Trials

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The importance of a strong statistical analysis continues to be a crucial part of drug and device development programs. Industry guidance highlights the importance of statistical power in proving efficacy and safety.  A randomized trial can benefit from covariate adjustments in order to protect against chance imbalances for important baseline covariates, thereby increasing study power.

In this guidance, the FDA discusses how to adjust for covariates in statistical analyses in randomized clinical trials in drug development programs. These recommendations apply to the use of covariates in the analysis of randomized, parallel group clinical trials and are applicable to both superiority trials and noninferiority trials. Rather than using predictive biomarkers to identify groups most likely to benefit from treatment, the guidance focuses on prognostic baseline factors to improve precision for estimating treatment effects.

Click here for the full guidance document.


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