Changes in Clinical Trial Practice and the Working Environment in the Korean Pharmaceutical Industry since the Implementation of Good Clinical Practice

Abstract

Since Good Clinical Practice (GCP) was enacted in Korea in 1995, many noticeable changes occurred in the pharmaceutical industry. GCP prompted pharmaceutical companies to introduce and maintain quality clinical research systems. This paper presents the results of two surveys (in 1995 and 1998) to evaluate how the implementation of GCP has improved clinical trial practice and the working environment in the Korean pharmaceutical industry. Improvements were most evident in local companies, but organizational support was not as consistent as necessary. With the scheduled upgrade of the Korean GCP to the International Conference on Harmonization (ICH) standard in 2000, the authors expect that more global trials will be performed in Korea.

Keywords

Good Clinical Practice Clinical trial Clinical research system Standard operating procedure Monitoring

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