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Key Design Considerations for Basket Trials and Umbrella Trials

With advancements in biomarkers and momentum in precision medicine, biomarker-guided trials such as basket trials and umbrella trials have been developed under the master protocol framework. A master protocol refers to a single, overarching design developed to evaluate multiple hypotheses with the general goal of improving the efficiency of clinical research. This webinar will introduce two master protocol types and explore their extension to design in various contexts from the HIV epidemic in global health to expedited oncology trials.

One type of master protocol is the basket trial, in which a targeted therapy is evaluated for multiple diseases that share common molecular alterations or risk factors that may help predict whether the patients will respond to the given therapy. Another variant of a master protocol is the umbrella trial, in which multiple targeted therapies are evaluated for a single disease that is stratified into multiple subgroups based on different molecular or other predictive risk factors. Both designs follow the core principle of precision medicine—to tailor intervention strategies based on the patient’s risk factor(s) that can help predict whether they will respond to a specific treatment. There have been increasing numbers of basket and umbrella trials, but they are still poorly understood. The purpose of this webinar is two-fold: firstly, to review the concept of master protocols and common characteristics of basket and umbrella trials; and secondly, to discuss important design considerations for these types of master protocols.

Your Presenter

Jay Park, Director, Cytel

Jay is a Director for Cytel based in Vancouver, BC. He recently joined the company in December 2019 when MTEK Sciences was acquired by Cytel. His research interests include application of master protocols, adaptive trial designs, and real-world analytics to global health. He currently teaches a course on adaptive trial designs and master protocols at McMaster University and is working on a book, “Introduction to Adaptive Trial Designs and Master Protocols” that will be published by Cambridge University Press in 2021.

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