Medication adherence is a critical driver of success in drug development and a fundamental component of trial integrity. Poor adherence introduces variability and bias that can obscure the true efficacy and safety of an investigational product, jeopardizing trial outcomes, regulatory decisions, and ultimately, patient care. Despite its significance, adherence is often underestimated or poorly monitored, with reliance on traditional methods such as pill counts and self-reporting that lack precision and reliability.
This webinar will examine how medication nonadherence should be proactively addressed as a key risk within a Risk-Based Quality Management (RBQM) framework, in line with the quality-by-design principles outlined in the ICH E6(R3) Good Clinical Practice guidance. We will explore how integrating adherence risk into trial design, monitoring, and data review processes enables early detection and mitigation of issues that could compromise scientific validity.
Adherence directly affects drug exposure, making it a central factor in interpreting trial outcomes. Intercurrent events like missed doses, treatment interruptions, or early discontinuations complicate estimations of treatment effect. By incorporating adherence data into the ESTIMAND framework of ICH E9(R1), sponsors can more accurately assess efficacy and safety, even in the presence of suboptimal exposure.
A standardized, data-driven approach to adherence, using real-time electronic monitoring systems, allows researchers to distinguish between expected variability and clinically significant nonadherence. These digital tools provide continuous, high-resolution dosing data that surpass traditional monitoring methods, offering feedback loops for patients and investigators, optimizing dose-exposure analyses, and improving decision-making in adaptive trial designs.
Real-time adherence data supports more credible and efficient trial conduct. It helps reduce unnecessary variance, enabling smaller sample sizes and more robust exposure-response modelling. It also enhances interim analyses by providing a clearer picture of drug effect and patient behaviour, helping avoid premature termination of trials and guiding post-trial analyses.
Join us to learn how embracing adherence as a measurable and manageable component of trial quality can enhance your clinical development strategy, reduce trial risk, and increase the likelihood of success in today’s evolving regulatory and scientific landscape.
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