Conduction of a Large-Scale Clinical Trial for a HMG-CoA Reductase Inhibitor / 薬剤疫学

ABSTRACT

A large-scale randomized prospective intervention study (Mega Study) was initiated by Ministry of Health and Welfare (MHW) Japan in 1993, and is on going with support from Sankyo Co., Ltd. This study is designed to test the hypothesis that reduction of serum cholesterol with pravastatin (a HMG-CoA reductase inhibitor) over an average of 5 years will reduce the incidence of fatal and nonfatal CHD (Coronary Heart Disease).<BR>As a CRO (Contract Research Organization), we have set up a data center that is responsible for the conduction of this study. The main functions of the data center are to do patient registration, treatment randomization, clinical monitoring, data management, and statistical analysis.<BR>This report outlines our some experiences with conduction of the data center, particularly relating to clinical monitoring, clinical data management, QA (Quality Assurance), and computer systems for such a data center.