Drug Evaluation Committee Handling of Missing Data in Clinical Trials
February 2025
This document was published in 2014 by Task Force 2 of the Data Science Subcommittee. It provides an easy-to-understand explanation of the discussions regarding missing data, including the concept of the “estimand” (used to clarify the purpose of a trial), analytical methods, sensitivity analysis, and strategies for minimizing the occurrence of missing data.In addition, the appendix includes the results of a survey on cases where missing data were discussed during the approval review processes at the FDA, EMA, and PMDA. Since these materials continue to serve as a valuable reference for many clinical trial professionals, we have decided to republish them.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Data Science Subcommittee FY2013 Task Force 2