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- E-ISSN 2288-3339
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- E-ISSN2288-3339
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Current Status of Institutional Review Boards and Approvals of Clinical Research in Oriental Medical Hospitals in Korea: A Survey
Journal of Korean Medicine / Journal of Korean Medicine, (P)1010-0695; (E)2288-3339
2010, v.31 no.1, pp.122-129
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(2010). Current Status of Institutional Review Boards and Approvals of Clinical Research in Oriental Medical Hospitals in Korea: A Survey. Journal of Korean Medicine, 31(1), 122-129.
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Abstract
Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics,institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board’s staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49%said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79%of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.
- keywords
- Institutional review board, clinical trial, IRB
Reference
1
1 식품의약품안전청. 의약품임상시험관리기준. 제2008-39호.
2
2 Shin SG. Current status of clinical trials in the Republic of Korea. Drug Inf J. 1997; 31(4):1079- 1087.
3
3 Park JE, Kang KW, Choi SM. Assessing Methodological Quality of Acupuncture Clinical Trials of Korea. The Journal of Korean Acupuncture & Moxibustion Society. 2007;24(1):127-135.
4
4 Korean Standard Classification Of Disease. Available at URL: http://www.nso.go.kr/std2006/k07c__0000/k07cb_0000/k07cb_0000.html.Accessed November 27, 2009.
5
5 Lee DH. Investigational New Drug Application in Korea. Kor J Clin Pharmacol Ther. 2002;2 (2):184-186.
6
6 International Conference on Harmonization(ICH). Good Clinical Practice: Consolidated Guideline. 1996.
7
7 Park BJ, Kim OJ, Lee SM, Shon DR, Shin SG. The Current Problems and Proposed Solutions for the Institutional Review Boards in Korea. Kor J Clin Pharmacol Ther. 2004;12(2):137-146.
8
8 Ko SG, Jun CY, Park JH, Han CH, Jung WS, Moon SK, et al. Establishment of Efficient Organization for Coordination Center on Clinical Research in Traditional Korean Medicine. J Korean Oriental Med. 2006;27(1):196-203.
9
9 Lee YJ. The direction of clinical management. 약의 날 학술대회. 2008.
10
10 경희대학교 한의과대학. 한방의료 및 한의약 관련제품에 관한 임상시험을 위한 한의학임상센터 운영 및 지원방안 연구. 경희대학교 한의과대학. 2004:208.
11
11 한국보건산업진흥원. 연구보고서 중.장기 한방 육성대책 수립 연구. 한국보건산업진흥원. 2002:23-24.
12
12 Seo JC, Kim SH, Rah JD, Jung SK, Kwon YK. Survey on the Demand for Clinical Trial Centers for Oriental Medicine. J Korean Oriental Med. 2005;26(2):85-94.
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