임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

국내 의약품 임상시험 실시기관에서의 임상시험 관리약국 운용 현황

A Study on Current Status of Clinical Trial Pharmacy in Domestic Clinical Trial Institution

  • 장유정 (경북대학교병원 임상시험센터) ;
  • 강원구 (영남대학교 약학대학) ;
  • 이주미 (경북대학교병원 임상시험센터) ;
  • 이혜원 (경북대학교병원 임상시험센터) ;
  • 박민수 (연세대학교 의과대학 세브란스병원 임상약리학과) ;
  • 윤영란 (경북대학교병원 임상시험센터)
  • Jang, Yoo-Jeong (Clinical Trial Center, Kyungpook National University Hospital) ;
  • Kang, Wonku (College of Pharmacy, Yeungnam University) ;
  • Lee, Joomi (Clinical Trial Center, Kyungpook National University Hospital) ;
  • Lee, Hae Won (Clinical Trial Center, Kyungpook National University Hospital) ;
  • Park, Min Soo (Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine) ;
  • Yoon, Young-Ran (Clinical Trial Center, Kyungpook National University Hospital)
  • 투고 : 2012.12.12
  • 심사 : 2013.06.01
  • 발행 : 2013.06.30
⟨ 이전 논문 다음 논문 ⟩

초록

Background: There is a lack of research on the status of clinical trial pharmacy and clinical trial pharmacist (CTP) in Korea. This study was aimed to investigate the current status of clinical trial pharmacy and clinical trial pharmacists. Methods: The survey was performed using the 41-item questionnaire designed to investigate information on the following; (1) current status of clinical trial pharmacy designated by Korea Food and Drug Administration, (2) current status of working condition, management, and satisfaction index of CTP. Data collected was analyzed by t-test and $x^2$. Results: Among the CTPs who responded, 92.7 % belonged to department of pharmacy, and 7.3 % to clinical trial center. 90.2 % of the respondents were women. Forty-two point seven percents of the respondents had more than 3 years of experience in the clinical trial field. 36.6 % answered that the current number of CTPs in the institution was '2'. Sixty-three point four percents answered that they subsumed an additional post. Regarding the question on "whether the equipment and working environment of your clinical trials pharmacy is adequate", 65.1 % of the respondents answered as 'Inadequate'. Ninety-eight point eight percents answered that work-related education is needed. Ninety-three point nine percents answered that the quality of clinical trials is related to the improvement of the working environment of CTP. Conclusion: Clinical trial pharmacy's facility and number of actually working CTP were insufficient. Proper and continuous education and training for CTPs are needed to improve the quality of clinical trials conducted in Korea, with strong institution support and timely regulation change.

키워드

과제정보

연구 과제 주관 기관 : 보건복지부

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