2011 年 131 巻 6 号 p. 969-975
This survey was conducted to investigate the current status and suggest future directions for clinical trials pharmacy in Korea. A 32-item survey was distributed to 96 hospital pharmacies conducting clinical trials. The questionnaire was designed to elicit information on the following: (1) general clinical trial status of each hospital, (2) Investigational Drug Service (IDS) performance status. The response rate was 59.4% and 61.8% of the respondents carried out all the regulatory IDSs. Independent of the IDS's performance, the respondent started to feel the need for reinforcement in human resources when the number of active studies crossed 35. Analyzing the workload based on the subjective need for reinforcement in CTP, the overall CTP work execution rate was significantly higher in the ‘needs reinforcement’ group (p<0.05), even though this group had a 2.3 times higher workload than that in the ‘current number of CTPs is adequate’ group. The ‘needs reinforcement’ group performed more efficiently with a better understanding of IDSs, even though the group was having difficulties due to the shortage of CTPs. The lower execution rate in the ‘current number of CTPs is adequate’ group can be assumed to be due to the lack of understanding of the scope of IDSs. The work of CTPs should evolve into one of the specialized hospital pharmacists’ roles, and a trial institution should designate at least one CTP per 40 protocols. Furthermore, the education for CTPs should be diversified into basic course and advanced course based on the IDS's performance of each hospital.
