Participant Adherence in Repeated-Dose Clinical Studies Using Video-Based Observation: Retrospective Data Analysis.

backgroundMaintaining accurate medication records in clinical trials is essential to ensure data validity. Traditional methods such as direct observation, self-reporting, and pill counts have shown limitations that make them inaccurate or impractical. Video-based monitoring systems, available as commercial or proprietary mobile applications for smartphones and tablets, offer a promising solution to these traditional limitations. In Korea, a system applicable to the clinical trial context has been developed and used.

objectiveThis study aimed to evaluate the usefulness of an asynchronous video-based self-administration of the investigational medicinal product (SAI) monitoring system (VSMS) in ensuring accurate dosing and validating participant adherence to planned dosing times in repeated-dose clinical trials.

methodsA retrospective analysis was conducted using data from 17,619 SAI events in repeated-dose clinical trials using the VSMS between February 2020 and March 2023. The SAI events were classified into four categories: (1) Verified on-time dosing, (2) Verified deviated dosing, (3) Unverified dosing, and (4) Missed dosing. Analysis methods included calculating the success rate for verified SAI events and analyzing trends in difference between planned and actual dosing times (PADEV) over the dosing period and by push notification type. The mean PADEV for each subsequent dosing period was compared with the initial period using either a paired t test or a Wilcoxon signed-rank test to assess any differences.

resultsA comprehensive analysis of 17,619 scheduled SAI events across 14 cohorts demonstrated a high success rate of 97% (17,151/17,619), with only 3% (468/17,619) unsuccessful due to issues like unclear video recordings or technical difficulties. Of the successful events, 99% (16,975/17,151) were verified as on-time dosing, confirming that the dosing occurred within the designated SAI time window with appropriate recorded behavior. In addition, over 90% (367/407) of participants consistently reported dosing videos on all analyzed SAI days, with most days showing over 90% objective dosing data, underscoring the system's effectiveness in supporting accurate SAI. There were cohort differences in the tendency to dose earlier or later, but no associated cohort characteristics were identified. The initial SAI behaviors were generally sustained during the whole period of participation, with only 16% (13/79) of study days showing significant shifts in actual dosing times. Earlier deviations in SAI times were observed when only dosing notifications were used, compared with using reminders together or no notifications.

conclusionsVSMS has proven to be an effective tool for obtaining dosing information with accuracy comparable to direct observation, even in remote settings. The use of various alarm features and appropriate intervention by the investigator or observer was identified as a way to minimize adherence deterioration. It is expected that the usage and usefulness of VSMS will be continuously improved through the accumulation of experience in various medical fields.