국내 임상시험 사전심사에서 임상시험심사위원회의 기능과 역할을 연구자적 입장에서 고찰

Abstract

Multinational clinical trials has required objective evidence to demonstrate success and results, recently. In particular, clinical testing has become a highly important part of the advanced countries where development of rare diseases and degenerative diseases that are difficult to treat with modern medical techniques or where development of new products is being developed competitively. Clinical trials performed on people are defined as tests to demonstrate the safety and effectiveness of medicines, medical devices, and so on. Since the subject is a human being, the issue of medical ethics as well as the results and validity of experiments must be confirmed also. Not only do researchers need to expect good results, they also need to check whether the test itself is legal or objective. In the research-oriented perspective, this complex process is perceived as an inconvenient and wasteful one, so even if they have good ideas, they are hesitant to conduct clinical trials. This paper summarizes the current state and the role of the clinical review board and institutional review board in Korea and this study tried to analyzes the problems of clinical review board systems in the research-oriented perspective. Environment to enable free clinical testing, as well as the quantitative expansion by industry-academic cooperation, is crucial for the rapidly changing circumstances of clinical trials for local researchers. We have analyzed the problems in the aspect of clinical trials and clinical review board so that Korean researchers may play a major role in the field of clinical testing, and we need to make efforts to develop clinical testing in the future.