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Chapter 8 - Basket Trials and Umbrella Trials

from Part III - Basic Ingredients for Master Protocols

Published online by Cambridge University Press:  20 March 2023

Jay J. H. Park ,
Edward J. Mills  and
J. Kyle Wathen
By
Jay J. H. Park ,
Edward J. Mills  and
J. Kyle Wathen
Jay J. H. Park
Affiliation:
McMaster University, Ontario
Edward J. Mills
Affiliation:
McMaster University, Ontario
J. Kyle Wathen
Affiliation:
Cytel, Cambridge, Massachusetts
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Summary

This chapter discusses characteristics of basket and umbrella trials and their key design considerations. Basket trials refer to clinical trials conducted to test one or more targeted therapies on multiple diseases that share common molecular alternations or other predictive risk factors. Umbrella trials refer to clinical trials that test two or more targeted therapies for a single disease that is stratified into multiple groups. In addition to sample size and randomisation considerations that are important to all clinical trials, specific design considerations that are important for basket and umbrella trials include: biological plausibility of targeted intervention(s), accuracy of biomarker assays, biospecimen collection procedures, and prevalence of targeted biomarker.

Keywords

basket trialsumbrella trialsprecision medicineprecison oncology
Type
Chapter
Information
Introduction to Adaptive Trial Designs and Master Protocols , pp. 87 - 100
Publisher: Cambridge University Press
Print publication year: 2023

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