Drug Evaluation Committee Covariate Adjustment of Randomized Controlled Trials Based on FDA Guidance
Data Science Subcommittee
June 2025
In 2023, the FDA issued the guidance "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products. The guidance focuses on the treatment of baseline prognostic covariates, primarily to improve statistical efficiency in estimating and testing treatment effects. Improving statistical efficiency is an important topic, as it can contribute to increasing the probability of trial success through increased power and reducing the number of subjects required. Therefore, an understanding of this guidance will be beneficial not only to statisticians, but also to all development personnel involved in either planning, conducting, analyzing, or reporting clinical trials.
In this report, the FDA Guidance is explained in the context of the ICH E9 and EMA guidelines that have been referenced in the past regarding covariate adjustment. In addition to the commentary including the Japanese translation of the guidance in the main body of the report, we have also prepared an Appendix with excerpts from the Japanese translation only. We hope that this report will help to improve the efficiency of clinical trials in the future.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee Task Force 3-1 for FY 2024
Report
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