Drug Evaluation Committee The video clips of the symposium "Covariate Adjustment for Improving Statistical Efficiency in Randomized Controlled Trials" are now available for viewing.

Feb 19, 2026

Task Force 3-1 of the Data Science Subcommittee is studying methods of covariate adjustment with the goal of conducting randomized controlled trials more efficiently in the future. In May 2023, the FDA issued the guidance "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products". In June 2025, the Task Force released a Task Force Deliverable, "Adjusting for Covariates in Randomized Clinical Trials Based on FDA Guidance," which includes an overview and Japanese translation of the FDA guidance, as well as a comparison with previously referenced guidelines and guidance. (URL: ( https://www.jpma.or.jp/information/evaluation/results/allotment/DS_202506_CovAd.html)) In addition to promoting understanding of the contents of this deliverable, this symposium will discuss the future of clinical trials without limiting the discussion to the FDA Guidance. This symposium aims to promote understanding of the content of this work and, without limiting the discussion to FDA guidance, to identify issues that may arise in future clinical trial planning and the statistical properties and regulatory concerns of new statistical methods that may be used in the future.

We hope that interested parties will join us.

Date: Monday, March 16, 2026, 13:00-17:30
Location: online (WebEX)