Evaluation of Good Clinical Practice(GCP) Implementability at the Designated Clinical Trial Hospitals

Jang, Sun-Mee; Lee, Eui-Kyung; Park, Byung-Joo; Huh, Soon-Im

Journal of Korean Society Quality Assurance Health Care 1995;2(1): 86.
Published online May 30, 1995.

임상시험 지정병원의 "의약품 임상시험 관리기준(KGCP)" 수행 가능성 평가에 관한 연구

장선미¹, 이의경¹, 박병주², 허순임³

¹한국보건사회연구원
²서울대학교 의과대학 예방의학 교실
³서울대 보건대학원

Evaluation of Good Clinical Practice(GCP) Implementability at the Designated Clinical Trial Hospitals

Sun-Mee Jang¹, Eui-Kyung Lee¹, Byung-Joo Park², Soon-Im Huh³

¹Korea Institute for Health and Social Affairs
²Department of Preventive Medicine, College of Medicine SNU
³School of Public Health SNU

Abstract

Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.