지역사회 임상시험시 개인별 무작위배정과 군집 무작위배정의 효율성 비교

Comparison of Efficiency between Individual Randomization and Cluster Randomization in the Field Trial

Objectives . In large-scale field trials, randomization by cluster is frequently used because of the administrative convenience, a desire to reduce the effect of treatment contamination, and the need to avoid ethical issues that might of otherwise arise. Cluster randomization trials are experiments in which intact social unit, e.g., families, schools, cities, rather than independent individuals are randomly allocated to intervention groups. The positive correlation among responses of subjects from the same cluster is in matter in cluster randomization. This thesis is to compare the results of three randomization methods by standard error of estimator of treatment effect. Methods : We simulated cholesterol data varing the size of the cluster and the level of the correlation in clusters and analyzed the effect of cholesterol-lowering agent. Results : In intra-cluster randomization the standard error of the estimator of treatment effect is smallest relative to that in inter-cluster randomization and that in individual randomization. Conclusions : Infra-cluster randomization is the most efficient in its standard error of estimator of treatment effect but other factor should be considered when selecting a specific randomization method.