Usefulness of Video-Based Observation and Self-Administration Patterns in Repeated-Dose Clinical Studies With Healthy Volunteers: A Retrospective Data Analysis (Preprint)

Abstract

It is imperative to maintain precise dosing records in repeated-dose pharmacokinetic studies involving healthy volunteers to ensure data validity. Conventional techniques, such as direct observation, self-reporting, and pill counts, often prove inadequate in terms of accuracy and practicality. Video-based monitoring systems have emerged as a promising alternative, offering enhanced accuracy and reduced burden on stakeholders. This study assesses the efficacy of an asynchronous video-based Self-Administration of the Investigational Product (SAI) monitoring system (VSMS) in ensuring accurate dosing in clinical trials with healthy volunteers in Korea.

The primary objectives of this study were to evaluate the usefulness of an asynchronous VSMS in validating subject SAI in a repeated-dose pharmacokinetic study and to explore patterns of subject compliance with planned dosing times, suggesting possible applications for such a system.

A retrospective analysis was conducted using data from 17,619 SAI events in repeated-dose clinical trials employing the VSMS between February 2020 and March 2023. The SAI events were classified into four categories: Verified On-time Dosing, Verified Deviated Dosing, Unverified Dosing, and Missed Dosing. Analysis methods included calculating the success rate for verified SAI events and analyzing trends in deviation 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.

The VSMS achieved a high success rate of 97%, with 99% of the classified as Verified On-time Dosing. An analysis of trends in dosing time deviations revealed a tendency towards delayed dosing in cohorts 1, 2, 6, 8, 12, and 14, while cohorts 3, 4, 5, 7, 9, 10, 11, and 13 exhibited a tendency to dose earlier than the planned time. A comparison of the initial and subsequent dosing periods revealed no significant differences in dosing time deviations for most cohorts. However, significant differences (P < .05) were observed on only 16% (13 out of 79 days). The analysis of the impact of push notification types revealed a trend towards the highest compliance with planned dosing times when both Dosing Notifications and Dosing Reminders were provided (average PADEV: -3.5 ± 31.3 minutes).

The VSMS effectively enabled real-time remote monitoring and verification of SAI events in early clinical trials. Additionally, the system facilitated control over subject SAI behavior through targeted push notifications and communication. Its utility is expected to grow with more data and experience.