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Updated: May 17, 2025

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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.

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Summary
This summary is machine-generated.

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.

Keywords:
adherencemobile healthmobile phonerepeated-dose clinical trialsself-administrationvideo-based monitoring

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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.