Drug Evaluation Committee Literature Review Related to Estimand and Sensitivity Analysis in Clinical Trials
Data Science Subcommittee
June 2019
The Drug Evaluation Committee's Data Science Subcommittee's Task Force 4 in 2018 will focus on issues strongly related to estimand and sensitivity analysis, which are considered in ICH E9 (R1): 1. Effects of treatment strategy and other treatment effects based on ITT principles, 2. Data handling and missing data. The report summarizes the results of the literature review on the following four topics: (1) effects of treatment strategies based on ITT principles and other treatment effects, (2) data handling and issues considered for inclusion in missing data, (3) the definition and role of the analysis population, and (4) stability and sensitivity analysis.
This literature review was conducted primarily through an exhaustive survey of literature published or released between 1998 and 2018, totaling approximately 400 references. Therefore, we believe that this report will enable us to organize the various discussions that have been made so far and to deepen our understanding of estimand and sensitivity analysis. Therefore, we hope that not only statisticians but also all persons in charge of drug development will read this document.
We hope that this report will help you plan and conduct clinical trials more appropriately in the future.
Literature review related to Estimand and sensitivity analysis in clinical trials_Ver1 (1.2MB)
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