Transl Clin Pharmacol.  2018 Jun;26(2):86-92. 10.12793/tcp.2018.26.2.86.

The first step to the powers for clinical trials: a survey on the current and future Clinical Trial Management System

• Park JS
• Moon SJ
• Lee JH
• Jeon JY
• Jang K
• Kim MG

• KMID: 2413832
• DOI: http://doi.org/10.12793/tcp.2018.26.2.86

Abstract

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.

Keyword

Clinical trial; Clinical trial information system; Clinical trial management system (CTMS); Integrated management system

MeSH Terms

Appointments and Schedules
Electronic Health Records
Humans
Korea
Prescriptions
Research Personnel
Surveys and Questionnaires

Figure

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  Figure 1 Current utilization of CTMSs by workplace. The total number of responses was 531. Each percentage of stacked bars was calculated for the number of respondents of each workplace.

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  Figure 2 The difference between the reasons for not using CTMSs among respondents who were not currently using a CTMS according to past usage. The question addressed the respondents' reasons for currently not using a CTMS, and multiple responses were allowed. Because the percentages were calculated by the number of answers divided by the number of respondents, the sum of percentages is over 100.

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