국내 의약품 임상시험 실시기관에서의 임상시험 관리약국 운용 현황
- 국내 의약품 임상시험 실시기관에서의 임상시험 관리약국 운용 현황
- Other Titles
- A Study on Current Status of Clinical Trial Pharmacy in Domestic Clinical Trial Institution
- 강원구; 장유정; 이주미[이주미]; 이혜원[이혜원]; 박민수[박민수]; 윤영란[윤영란]
- Clinical trial pharmacist; Clinical trial pharmacy; Current status; Education
- Issue Date
- Translational and Clinical Pharmacology, v.21, no.1, pp.71 - 81
- 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 χ².
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.
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