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 explanations of estimand, a concept used to organize trial objectives, analysis methods, sensitivity analysis, and measures to minimize the occurrence of missing data. 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, Committee on Drug Evaluation
Data Science Subcommittee 2013 Task Force 2
Deliverables of the Drug Evaluation Committee Return to list of all deliverables