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J Korean Med Assoc > Volume 53(9); 2010 > Article
Han and Yim: Current state of clinical trials in Korea

Abstract

The number of clinical trials sponsored by global pharmaceutical companies performed in countries other than the U.S. and Western Europe has been steadily increasing over the past decade. Among those emerging countries, Korea deserves attention for its rapid growth in the number of trials and sites. As of 2009, Korea was ranked the tenth country in the number of clinical trials registered at http://clinicaltrials.gov. This is remarkable growth given that it was not included in the top 30 countries in 2005. High population density, qualified medical professionals, regulatory changes including Investigational New Drug-New Drug Application (IND/NDA) separation, acceptance of International Conferences on Harmonization-Good Clinical Practices (ICH-GCP) by Korea Food&Drug Administration (KFDA), and governmental policies to boost clinical trials were the most influential factors that caused such an outstanding achievement. The Korean National Enterprise for Clinical Trials (KoNECT), an organization founded to lead initiatives to improve the milieu for clinical trials, has been playing a pivotal role in the steering of 15 regional clinical centers designated by the government. Based upon improvements in infrastructure so far, diversity in therapeutic areas and the proportion of early phase trials are expected to grow. Korea has grown to be one of the major countries in the clinical trial market, which was made possible by the cooperation of industry, academia and government. Further investment and efforts to solve current challenges will allow such growth to continue into the next decade.

References

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Figure 1
Number of clinical trials approved by KFDA [7].
jkma-53-745-g001-l.jpg
Figure 2
R&D investment by global pharmaceutical companies in Korea[10].
jkma-53-745-g002-l.jpg
Figure 3
Numbers (A) and densities (B, institutions per 100,000 residents) of clinical trial institutions by region.
jkma-53-745-g003-l.jpg
Table 1
Accredited institutions and recognized IRBs in Korea[12, 13]
jkma-53-745-i001-l.jpg
Table 2
Number of clinical trials (world) classified by phases and their annual growth rates in 2008 and 2009 (Dialog Corporation[7])
jkma-53-745-i002-l.jpg
Table 3
Company-sponsored clinical trials-North America, Europe and Korea in 2009 (www.clinicaltrials.gov)[7]
jkma-53-745-i003-l.jpg
Table 4
Therapeutic areas of clinical trials: INDs submitted to U.S. FDA vs. KFDA IN 2009[16]
jkma-53-745-i004-l.jpg


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