臨床試験に付随した医療経済評価の統計解析法

─生存時間解析に重点を置いて─

抄録

It has been accepted worldwide that the cost as well as the effectiveness and toxicity is an essential part in the assessment of medical interventions. Following several countries, in Japan, the evaluation of cost-effectiveness was put into effect in 2019 . There are mainly two methods in cost-effective analysis: cost-effectiveness analysis alongside clinical trials and analysis using decision analytic modeling. Cost-effectiveness analysis alongside clinical trials, where utility and cost data are obtained from individual patients, has the advantage of high internal validity. In economic evaluation alongside trials, censoring frequently occurs in acquiring utility and cost data from individual patients and techniques of survival analysis is necessary to consider censoring into account. Methods using Kaplan-Meier survival estimator and inverse-probability weighting estimator are frequently used to account for censoring in the estimation of effectiveness and cost. In this paper, we provide an outline of the statistical methods on economic evaluation alongside trials, stressing especially the estimation of effectiveness and cost using survival analysis techniques to account for censoring