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Proposed Requirements for Clinical Trial Management Systems in Digital Therapeutics Trials
Moses Yook1, Soo Kyung Yoon1, Dai Jin Kim2
1The Catholic University of Korea, Department of Medical Informatics.
Studies in Health Technology and Informatics
|May 23, 2026
Summary
Conventional clinical trial management systems (CTMS) need upgrades for digital therapeutics (DTx). This research outlines essential requirements to lower costs and boost DTx adoption and market growth.
Area of Science:
- Health Informatics
- Digital Therapeutics
- Clinical Trial Management
Background:
- Conventional clinical trial management systems (CTMS) are not designed for digital therapeutics (DTx).
- This limitation hinders the effective management and scaling of DTx clinical trials.
Purpose of the Study:
- To define specialized requirements for CTMS to support DTx.
- To identify features that reduce costs and facilitate broader clinical adoption and market expansion of DTx.
Main Methods:
- Analysis of current CTMS functionalities.
- Identification of specific DTx requirements.
- Development of a proposed requirements framework.
Main Results:
- Key features lacking in conventional CTMS for DTx were identified.
- A set of specialized requirements was proposed.
- Potential cost reductions and adoption benefits were outlined.
Conclusions:
- CTMS require significant adaptation to effectively support digital therapeutics.
- Implementing specialized requirements can accelerate DTx clinical trials, adoption, and market growth.
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