국내 항암제의 임상현황 및 항암제 임상시험 가이드라인

Current Status of Clinical Trials for Approval of Anticancer Drugs in Korea and Some Guidelines

The enormous cost, intensive time, and constant efforts are required the drug discovery and development of bringing new drug products to the marketplace. The past several years, KFDA approved new drugs developed by local pharmaceutical industries; that is Sunppla, Factive etc. In addition to, investigational new drug application (IND) was established to accelerate new drug development and harmonize with international standards in 2002. At this point of time it is urgent problem to develop ability of reviewing new drug applications (NDAs) scientifically and appropriately to ensure that new drugs are safe and effective. There are many scientific issues embedded in new drug approval process from non-clinical studies to phase 3 clinical trials; 1) sample size, 2) application of end point, 3) statistical method, and etc. However the overall relation between protocols/reports of clinical trials and the characteristics of domestic medical system has fully not been studied. There is also, no references or data for the point to be considered in drug approval process. On this background, the objectives of this study are introduction of guidelines for the requirement for approval or evaluation of safety/efficacy in other countries and presentation how to practice clinical trial for new oncologic products in the present situation of clinical trial. We hope that the guidelines contribute to providing methods of clinical trials and procedures, and evaluating method to develop chemotherapeutic agents.