Statistical Analysis of Treatment Compliance for Clinical Trials using Electronic Compliance Monitoring
type: CreativeWork
description: Compliance, the extent to which patients follow a medication regimen, has been recognized as one of the most serious problems facing medical practice today. Recent developments in assessing compliance include electronic compliance monitors (ECM), devices that record the date and time of the release of medication from its original container. This allows utilizing ECM compliance data in statistical analyses related to clinical trials. This thesis proposes ways of dealing with the time-varying nature of compliance. We examine the compliance behaviour from real ECM data through statistical analysis of compliance rate, followed by a time-to-event analysis with respect to first noncompliance event. Then, using discrete event simulation and proportional hazards models we compare analyses using a fixed treatment covariate and time-varying compliance covariate based on pharmacokinetic principles in estimating treatment effect. We observe a reduction of up to 40% in EMSE in favour of the latter model for treatment effect estimation.
abstract: Compliance, the extent to which patients follow a medication regimen, has been recognized as one of the most serious problems facing medical practice today. Recent developments in assessing compliance include electronic compliance monitors (ECM), devices that record the date and time of the release of medication from its original container. This allows utilizing ECM compliance data in statistical analyses related to clinical trials. This thesis proposes ways of dealing with the time-varying nature of compliance. We examine the compliance behaviour from real ECM data through statistical analysis of compliance rate, followed by a time-to-event analysis with respect to first noncompliance event. Then, using discrete event simulation and proportional hazards models we compare analyses using a fixed treatment covariate and time-varying compliance covariate based on pharmacokinetic principles in estimating treatment effect. We observe a reduction of up to 40% in EMSE in favour of the latter model for treatment effect estimation.
author: Sirois, Jean-Karl
language: en
keywords: Compliance, Pharmacokinetic, Treatment Effect, Discrete Event Simulation
date published: 2015-04-15T18:24:24Z
date modified: 2026-07-24T03:39:29Z
provider: University of Ottawa
publisher: Networked Digital Library of Theses and Dissertations
type: WebPage
source organization: Université d'Ottawa / University of Ottawa

PropertyValue
property ID: Handle
value: http://hdl.handle.net/10393/32235

PropertyValue
property ID: DOI
value: 10.20381/ruor-3900