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

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.

Rooibos™: Automated schedule broadcast software for clinical pharmacology studies

Pharmacokinetic blood sampling is a prerequisite for successful early clinical trials. It is essential to take samples at the precise designated times to ensure the reliability of the clinical trial data; however, investigators have encountered difficulties in conducting procedures with limited manpower. We have recently developed automated schedule broadcast software (Rooibos™) to manage the precise scheduling of procedures for clinical trial centers. Rooibos™ is platform independent because it is programmed in the Java language. It generates scheduled times based on a reference time. It alarms at the scheduled times and pages subjects and alerts staff to prepare for the upcoming procedures. Rooibos™ can also group subjects when multiple clinical trials are conducted simultaneously in one or more clinical trial wards. This software may be applied to any study involving procedures that must be performed at designated times.

A Study for Effective Gaze Fixation Induction Methods in PC-Based Visual Field Testing

PURPOSE: The present study explored novel methods in visual field tests that actively induce the gaze of the examinee to the fixation target in the center vision and compared their effectiveness. METHODS: Four gaze induction methods (dot-on, dot-off, number-on, and number-off) were prepared by combining 2 types of fixation targets (dot and number) and 2 conditions of sound presence (on and off). The gaze induction methods were implemented to a PC-based visual field testing system and the 24-2 visual field testing protocol was administered to 14 participants without glaucoma. The performance of the gaze induction method was evaluated in terms of fixation error rate, target detection rate, and subjective satisfaction (7-point scale, 1 for least satisfied and 7 for most satisfied). RESULTS: The fixation error rates of dot-on (5.7%) and number-on (6.4%) were relatively lower than the other methods; the target detection rates of the induction methods were very high (95-96%) without significant differences, and the subjective satisfaction levels of dot-on (5.7) and number-on (5.4) were significantly higher than the other methods. CONCLUSIONS: In the present study we determined number-on as the preferred effective gaze induction method compared to the conventional dot-off method when fixation error rates and subjective satisfaction were considered.