Changes in Clinical Trial Practice and The Working Environment in The Korean Pharmaceutical Industry Since The Implement
- PDF / 704,594 Bytes
- 8 Pages / 504 x 719.759 pts Page_size
- 56 Downloads / 159 Views
0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
CHANGES IN CLINICAL TRIAL PRACTICE AND THE WORKING ENVIRONMENT IN THE KOREAN PHARMACEUTICAL INDUSTRY SINCE THE IMPLEMENTATION OF GOOD CLINICAL PRACTICE HOWARD LEE, MD, PHD Research Fellow, Center for Drug Development Science, Georgetown University Medical Center, Washington, District of Columbia
CHARLESJ. KIM, MD, PHD Vice President and Medical Director, Memcal Department, MSD Korea, Seoul, Korea
SANG-GOOSHIN,MD, PHD Professor, Department of Clinical Pharmacology. Seoul National University College of Medicine, Seoul, Korea
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 pharmuceutical 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. Key Words: Good Clinical Practice; Clinical trial; Clinical research system; Standard operating procedure; Monitoring
and experienced in clinical trial and monitoring-related activities than CRAs from foreign A SURVEY BY Kim and Lee et in 1995 subsidiaries or joint ventures (1). The survey showed that clinical research associates was conducted just prior to the enactment of (CRAs) from local Korean pharmaceutical the first Good Clinical Practice legislation in companies were less knowledgeable, trained, Korea. It also revealed that no local pharmaceutical companies had standard operating procedures (SOPS) for clinical trial manageReprint address: Howard Lee, MD. PhD, Center for ment and monitoring while 100% of foreign Drug Development Science, Georgetown University subsidiaries and 91% Of joint ventures did Medical Center, 3900 Reservoir Road m,Med-Dent
INTRODUCTION
Building NE 405, Washington, DC 20007. E-mail: HL8 @gunet.georgetown.edu.
(1).
203
Since the GCP Guideline was enacted in
Downloaded from dij.sagepub.com at GRAND VALLEY STATE UNIV LIB on June 10, 2015
Howard Lee, Charles J. Kim, and Sang-Goo Shin
204
Korea in October 1995 (2), there have been improvements in clinical trial practice and the environment, especially from the pharmaceutical industry’s viewpoint. To determine whether and how the GCP implementation has changed the industry’s clinical trial practice with respect to clinical trial SOPS, and CRAs’ active involvement in monitoring and their knowledge related to clinical trials, we performed a similar, but extended, survey in June 1998. In this second survey, we also tried to assess clinical researchers’ experience, competency, and working environment by company types
Data Loading...
