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