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지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록· 키워드
오류제보하기
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.
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.
목차
서론
연구방법
연구결과
고찰
감사의 글
참고문헌
참고문헌 (12)
참고문헌 신청
1. [기타자료] - 식품의약품안전청 / 2008 / 의약품임상시험관리기준
2. [학술지(정기간행물)] - Shin SG / 1997 / Current status of clinical trials in the Republic of Korea / Drug Inf J. 31 (4) : 1079 ~ 1087
3. [학술지(정기간행물)] - 박지은 / 2007 / 한국 침 임상시험의 질 평가 및 분석 / 대한침구학회지 24 (1) : 127 ~ 135
4. [인터넷자원] - / / Korean Standard Classification Of Disease
5. [학술지(정기간행물)] - 이동희 / 2002 / 새로운 IND(Investigational New Drug Application) 제도 / 임상약리학회지 10 (2) : 184 ~ 186
2. [학술지(정기간행물)] - Shin SG / 1997 / Current status of clinical trials in the Republic of Korea / Drug Inf J. 31 (4) : 1079 ~ 1087
3. [학술지(정기간행물)] - 박지은 / 2007 / 한국 침 임상시험의 질 평가 및 분석 / 대한침구학회지 24 (1) : 127 ~ 135
4. [인터넷자원] - / / Korean Standard Classification Of Disease
5. [학술지(정기간행물)] - 이동희 / 2002 / 새로운 IND(Investigational New Drug Application) 제도 / 임상약리학회지 10 (2) : 184 ~ 186
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UCI(KEPA) : I410-ECN-0101-2014-519-000280990