🎯 Lack of Medication Adherence: A Hidden Risk in Clinical Trials?
Medication adherence is a critical yet underestimated factor that directly impacts trial outcomes, data integrity, and regulatory success. Poor adherence introduces variability and bias, masking true drug effects and putting your study at risk.
This webinar explores how adherence should be managed as a core risk within a Risk-Based Quality Management (RBQM) framework, fully aligned with ICH E6(R3) and Quality by Design principles.
What We’ll Cover?
Why nonadherence is a scientific risk, not just a behavioral issue
How to integrate adherence into trial design, monitoring, and data review
Using digital tools for real-time, high-resolution adherence data
Applying adherence insights within the ESTIMAND framework (ICH E9(R1))
Reducing variance, optimizing exposure-response modeling, and improving trial efficiency
Why Attend?
Learn how measuring and managing adherence can:
🔹 Improve trial quality and reliabilityDon’t let adherence be the blind spot in your trial strategy.
Join us to discover how real-time, data-driven adherence management can transform trial quality, reduce risk, and increase the chances of regulatory and scientific success.
Bringing over 20 years of extensive clinical trials expertise, Rakhi Kilaru is pillar head for statistical science in the Biostatistics and Programming group at PPDTM clinical research business of Thermo Fisher Scientific. Her leadership spans Phase II–III studies across dermatology, cardiovascular, neuroscience, and inflammatory disorders. Ms. Kilaru is a recognized expert in centralized statistical monitoring and statistical surveillance methods, championing quality-by-design approaches. A former statistician in Duke Medicine, she has co-authored numerous peer-reviewed publications, including a 2024 review on quality tolerance limits in clinical trials. An active leader in the American Statistical Association’s Biopharmaceutical section, she holds an MS and MBA and serves on multiple scientific committees.
Dr. Bruce Binkowitz earned his Ph.D. from the Rutgers School of Public Health in 2000, and in 2022 was honored by the RUSPH with the Distinguished Alumni Award. Dr. Binkowitz has over 30 years of drug development experience, and is currently the Vice President of Biometrics at Arcutis Biotherapeutics, Inc. Prior to joining Arcutis, Dr. Binkowitz was the VP of Biometrics at Shionogi, Inc., after spending the majority of his career at Merck and Co. He has worked across all phases of drug development and across multiple therapeutic areas including dermatology, oncology, respiratory, metabolism/diabetes, cardiovascular, and ophthalmology. Dr. Binkowitz is recognized as a thought leader on the topic of multiregional clinical trials, culminating in being co-editor of the textbook “Simultaneous Global New Drug Development”. Dr. Binkowitz is a 2015 fellow of the American Statistical Association (ASA) and was the 2020 Chair of the Biopharmaceutical Section of the American Statistical Association. Prior to earning his Ph.D., Dr. Binkowitz earned a Master’s degree in Statistics from the University of Florida, and a Bachelor’s degree in Mathematics/Statistics from Rutgers College. He has established a School of Public health scholarship for Masters degree public health students to honor Dr. George Rhoads. Please consider donating at https://give.rutgersfoundation.org/pledge-payment/20795.html
Richard C. Zink is Principal Research Fellow at JMP Statistical Discovery and has spent more than 20 years in and around clinical trials and medical product development. He is author, editor, and contributor to 9 books on statistical topics in clinical trials and clinical research. Richard holds a Ph.D. in Biostatistics from the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill, where he serves as Adjunct Professor of Biostatistics and Adjunct Assistant Professor for the Department of Public Health Leadership and Practice. Richard was awarded the distinction of Fellow of the American Statistical Association in 2020.
Bernard Vrijens pioneered a research program focused on a simple but robust taxonomy of common dosing errors, along with exploring optimal measurement-guided medication management that can drive adherence and maintain long-term persistence. With over 100 peer-reviewed scientific papers and six patents to his name, Dr. Vrijens is also a founding member of the International Society for Medication Adherence (ESPACOMP) and an active contributor to several EU and US-funded collaborative projects, cementing his status as a leading authority in the field.
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