-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 datermine 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) reportiong 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 becaues
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.
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