초록 close

Objectives : The aim of this study is to investigate how does the methods of treatment and diagnosis of Traditional Korean Medicine (TKM) get the evidence of efficacy and safety and what type of efficient body and appropriate facility of the coordination center for clinical trial in TKM. Methods : We have got the information of clinical trial center or clinical collaboration center by site invitation, search of paper and reports and internet exploration for the domestic or foreign site.Results : Coordination center for clinical trial usually involves every steps of clinical trials. such as development of Case Report Form (CRF), design of study, calculation of sample size, randomization, maintenance of blinding, monitoring and audit of the resource document, data and CRF, data entry, quality control of data, analysis and report. Conclusions : The body needs several areas of experts, which are epidemiologists, biostatisticians, research nurses for coordination, data manager and programmer, and administrator. This body would be enhance and help the clinical researches including clinical trials in TKM.