A Clinical Data Management System for Diabetes Clinical Trials

Abstract

Background. The use of novel medications and methods to prevent, diagnose, treat, and manage diabetes requires confirmation of safety and efficacy in a well-designed study prior to widespread adoption. Diabetes clinical trials are the studies that examine these issues. The aim of the present study was to develop a web-based system for data management in diabetes clinical trials. Methods. The present research was a mixed-methods study conducted in 2019. To identify the required data elements and functions to develop the system, 60 researchers completed a questionnaire. The designed system was evaluated using two methods. The usability of the system was initially evaluated by a group of researchers (n = 6) using the think-aloud method, and after system improvement, the system functions were evaluated by other researchers (n = 30) using a questionnaire. Results. The main data elements which were required to develop a case report form included “study data,” “participant’s personal data,” and “clinical data.” The functional requirements of the system were “managing the study,” “creating case report forms,” “data management,” “data quality control,” and “data security and confidentiality.” After using the system, researchers rated the system functions at a “good” level (6.3 ± 0.73) on a seven-point Likert scale. Conclusion. Given the complexity of the data management processes in diabetes clinical trials and the widespread use of information technologies in research, the use of clinical data management systems in diabetes clinical trials seems inevitable. The system developed in the current study can facilitate and improve the process of creating and managing case report forms as well as collecting data in diabetes clinical trials.

Data management system for diabetes clinical trials: a pre-post evaluation study

“…In the present study, quality and usability of a previously developed clinical data management system for diabetes clinical trials were evaluated [32]. The results revealed that there was no statistically significant differences between the users' expectations of "information quality", "service quality", "achievements" and "communications" before and after using the system and their expectations were met.…”

“…Data management of clinical trials is a complex process that can be facilitated by using information and communication technologies (ICT) [35]. Clinical data management systems are technologies that can play an effective role in clinical data management, especially in multicenter clinical trials [32]. These systems support various aspects of data management, reduce financial and manpower costs, and facilitate data collection and management by eliminating manual processes and reducing workload [32,35,36].…”

“…Clinical data management systems are technologies that can play an effective role in clinical data management, especially in multicenter clinical trials [32]. These systems support various aspects of data management, reduce financial and manpower costs, and facilitate data collection and management by eliminating manual processes and reducing workload [32,35,36]. However, many systems have not been properly evaluated in terms of quality, usability, and impact [21,[37][38][39][40][41][42].…”

“…Previously, a clinical data management system was designed for diabetes clinical trials in Iran [32]. The purpose of this system was to provide a regular and electronic process for data management in diabetes clinical trials.…”

“…1 shows, the main functions of the system were designing clinical trials, defining users' roles, creating case report forms, auditing, documenting clinical data management process, reviewing participants' records, generating reports and statistics, locking databases, and backing to the profile. In addition, a clinical trial manger was able to define a clinical trial setting, design case report forms, annotate forms, create databases, validate data, manage data discrepancies, resolve data disputes, and maintain data security [32]. The purpose of this study was to evaluate the quality and usability of this system from the users' perspectives.…”