Drug Evaluation Committee Handling of Missing Data in Clinical Trials
Data Science Subcommittee
February 2025
This document was published by the Data Science Subcommittee Task Force 2 in 2014. It summarizes the content of discussions related to missing data and provides easy-to-understand Explanation of the concept of estimand, analysis methods, sensitivity analysis, and measures to minimize the occurrence of missing data in order to organize study objectives. In addition, a survey of cases in which missing data were discussed by the FDA, EMA, and PMDA during the approval review process is included in the Appendix. We decided to republish these materials because many people involved in clinical trials still refer to them.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee 2013 Task Force 2