임상시험을 위한 연구계획서의 오류에 대한 고찰

Abstract

Statistics are essential for clinical trials, and it is very important to have an accurate understanding of the purpose of the study and to apply the appropriate statistical design or methodology. Prior to conducting a clinical trial, the research protocol requires approval from the IRB (Institutional Review Board) or regulatory agency approval, and contains a variety of contents. The research protocol conducts clinical trials according to GCP (Good Clinical Practice) and describe clinical design and statistical methodologies for demonstrate the efficacy and safety of new drug or new medical devices using the obtained data in clinical trials. At this time, statistical design is applied for the protocol based on the primary study objective. The primary study objective is to influence the selection of primary endpoint to evaluate this, the sample size, the technique of minimizing the bias, the statistical analysis and method of testing the statistical hypothesis. However, statistical errors and contradictions are easy to find in the study protocol and the same errors are repeated many times, so in this paper we aim to avoid these errors in clinical studies and apply them correctly in clinical trials, intended to be helpful in derives scientific design, validity, and reliable results