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KMID : 0391020100180020096
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2010 Volume.18 No. 2 p.96 ~ p.108
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The Investigator Initiated Clinical Trial in Japan
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Ahn Byung-Jin
Lim Chi-Yeon
Nagata Ryu-Ji
Choi Min-Joung
Kim Hee-Jung
Lee Jong-Tae
Yim Hyeon-Woo
Kim Seong-Muk
Jeun Sin-Soo
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Abstract
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Non-commercial investigator-initiated clinical trials are different from commercial trials sponsored by company according to trial purpose. Irrespective of Korean government’s efforts there are no definite guidelines for investigator-initiated clinical trials using unapproved drugs such as gene materials except clinical research using cell products and market-approved drugs. In USA and EU, the clinical trial results from non-commercial process could be used for marketing approval, if it is proven that the clinical trial has been done according to ICH-GCP guideline. However, In Japan, "chiken (clinical trial)" and "clinical research" are separated. In the clinical research except stem cell and gene therapy, the scientific and ethical aspects of new technology or therapeutics are reviewed only by the institutional review board (IRB), not by the regulatory agency. In the case of "chiken", the applicant has to submit a clinical trial application to the Pharmaceuticals and Medical Devices Agency (PMDA). To reduce administrative burdens and encourage the investigator-initiated trials, investigator-initiated chiken process was developed in Japan. Therefore, to improve and promote the clinical trials initiated by investigator in Korea, it is time to focus on Japan’s investigator-initiated chiken process.
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KEYWORD
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Investigator- initiated, Clinical trial, Clinical research, Chiken, Japan
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