Park Jin-Sol, Moon Seol Ju, Lee Ji-Hyoung, Jeon Ji-Young, Jang Kyungho, Kim Min-Gul
Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju 54907, Republic of Korea.
Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju 54907, Republic of Korea.
Transl Clin Pharmacol. 2018 Jun;26(2):86-92. doi: 10.12793/tcp.2018.26.2.86. Epub 2018 Jun 18.
A clinical trial management system (CTMS) is a comprehensive program that supports an efficient clinical trial. To improve the environment of clinical trials and to be competitive in the global clinical trials market, an advanced and integrated CTMS is necessary. However, there is little information about the status of CTMSs in Korea. To understand the utilization of current CTMSs and requirements for a future CTMS, we conducted a survey on the subjects related to clinical trials. The survey was conducted from July 27 to August 16, 2017. The total number of respondents was 596, and 531 of these responses were used. Almost half of the respondents were from hospitals (46%). The proportion of respondents who are currently using a CTMS was the highest for contract research organizations at 59%, whereas the proportion used by investigators was 39%. The main reason for not using a CTMS was that it is unnecessary and expensive, but it showed a difference between workplaces. Many respondents frequently used CTMSs to check the clinical trial schedule and progress status, which was needed regardless of workplace. While two-thirds of users tended to be satisfied with their current CTMS, there were many users who felt their CTMS was inconvenient. The most requested function for a future CTMS was one that could be used to manage the project schedule and subject enrollment status. Additionally, a systematic linkage to electronic medical records, including prescription and laboratory test results, and a function to confirm the participation history of subjects in other hospitals were requested.
临床试验管理系统（CTMS）是一个支持高效临床试验的综合程序。为了改善临床试验环境并在全球临床试验市场中具有竞争力，先进且集成的CTMS是必要的。然而，关于韩国CTMS的现状信息很少。为了了解当前CTMS的使用情况以及对未来CTMS的需求，我们对与临床试验相关的主题进行了一项调查。该调查于2017年7月27日至8月16日进行。受访者总数为596人，其中531份回复被采用。几乎一半的受访者来自医院（46%）。目前使用CTMS的受访者比例在合同研究组织中最高，为59%，而研究者使用的比例为39%。不使用CTMS的主要原因是认为其不必要且昂贵，但在不同工作场所存在差异。许多受访者经常使用CTMS来查看临床试验时间表和进展状态，无论工作场所如何，这都是需要的。虽然三分之二的用户倾向于对他们当前的CTMS感到满意，但也有许多用户觉得他们的CTMS不方便。对未来CTMS最需求的功能是可用于管理项目时间表和受试者入组状态的功能。此外，还要求与包括处方和实验室检查结果在内的电子病历进行系统链接，以及确认受试者在其他医院参与历史的功能。
