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Participant Adherence in Repeated-Dose Clinical Studies Using Video-Based Observation: Retrospective Data Analysis
Seunghoon Han1, Jihong Song2,1, Sungpil Han2,1
1Department of Pharmacology, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
JMIR Mhealth and Uhealth
|April 7, 2025
Summary
Video-based monitoring systems (VSMS) accurately track medication adherence in clinical trials, offering a reliable alternative to traditional methods. This technology ensures data validity and participant compliance, improving trial outcomes.
Area of Science:
- Clinical Trials
- Pharmaceutical Science
- Digital Health
Background:
- Traditional clinical trial medication adherence monitoring methods (observation, self-reporting, pill counts) are often inaccurate or impractical.
- Video-based monitoring systems (VSMS) offer a promising solution for accurate medication adherence tracking.
- A VSMS has been developed and implemented in Korea for clinical trial applications.
Purpose of the Study:
- To evaluate the usefulness of an asynchronous video-based self-administration of the investigational medicinal product (SAI) monitoring system (VSMS).
- To assess the system's ability to ensure accurate dosing and validate participant adherence to planned dosing times in repeated-dose clinical trials.
Main Methods:
- Retrospective analysis of 17,619 self-administration of the investigational medicinal product (SAI) events from February 2020 to March 2023.
- Classification of SAI events into verified on-time, verified deviated, unverified, and missed dosing categories.
- Analysis of success rates, dosing time deviations (PADEV), and trends using statistical tests.
Main Results:
- The VSMS achieved a high overall success rate of 97% for SAI events.
- 99% of successful events were verified as on-time dosing, demonstrating high accuracy.
- Over 90% of participants consistently submitted dosing videos, with sustained adherence throughout trials; notification types influenced dosing times.
Conclusions:
- VSMS provides accurate dosing information comparable to direct observation, even in remote clinical trial settings.
- Utilizing alarm features and investigator intervention can minimize adherence deterioration.
- Continued experience with VSMS is expected to enhance its utility across various medical fields.
Keywords:
adherencemobile healthmobile phonerepeated-dose clinical trialsself-administrationvideo-based monitoringMore Related Videos
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