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Current Status and Future Directions for Clinical Trials Pharmacy

机译：临床试验药学的现状和未来方向

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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 overallCTP work execution rate was significantly higher in the 'needs reinforcement5 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.
机译：这项调查旨在调查韩国的现状并为临床试验药房提出未来的建议。向进行临床试验的96家医院药房分发了32项调查。该问卷旨在获取以下方面的信息：（1）每家医院的一般临床试验状态;（2）研究药物服务（IDS）的运行状态。回应率为59.4％，而61.8％的回应者进行了所有规管IDS。独立于IDS的绩效，当活动研究的数量超过35时，受访者就开始感到需要加强人力资源。基于主观需要CTP的工作量进行分析，在CTP中总体CTP工作执行率明显更高。 “需要加强5组（p <0.05）”，尽管该组的工作量比“当前CTP数量足够”组的工作量高2.3倍。 “需求加强”小组在更好地了解IDS的情况下更有效地开展工作，尽管该小组由于CTP短缺而遇到困难。可以认为“当前CTP数量足够”组中较低的执行率是由于缺乏对IDS范围的了解。 CTP的工作应演变为医院专业药剂师的角色之一，并且试验机构应每40个方案至少指定一个CTP。此外，CTP的教育应根据各医院IDS的表现分为基础课程和高级课程。

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