Development of a Mobile Application for Smart Clinical Trial Subject Data Collection and Management

Wearable devices and digital health technologies have enabled the exchange of urgent clinical trial information. We developed an application to improve the functioning of decentralized clinical trials and performed a heuristic evaluation to reflect the user demands of existing clinical trial workers. The waterfall model of the software life cycle was used to guide the development. Focus group interviews (N = 7) were conducted to reflect the needs of clinical research professionals, and Wizard of Oz prototyping was performed to ensure high usability and completeness. Unit tests and heuristic evaluation (N = 11) were used. Thematic analysis was performed using the focus group interview data. Based on this analysis, the main menu was designed to include health management, laboratory test results, medications, concomitant medications, adverse reactions, questionnaires, meals, and My Alarm. Through role-playing, the functions and configuration of the prototype were adjusted and enhanced, and a heuristic evaluation was performed. None of the heuristic evaluation items indicated critical usability errors, suggesting that the revised prototype application can be practically applied to clinical trials. The application is expected to increase the efficiency of clinical trial management, and the development process introduced in this study will be helpful for researchers developing similar applications in the future.