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2 results

  • Chapter 8 - Basket Trials and Umbrella Trials

  • from Part III - Basic Ingredients for Master Protocols
  • Jay J. H. Park, McMaster University, Ontario, Edward J. Mills, McMaster University, Ontario, J. Kyle Wathen, Cytel, Cambridge, Massachusetts
  • Book:
    Introduction to Adaptive Trial Designs and Master Protocols
    Published online:
    20 March 2023
    Print publication:
    06 April 2023, pp 87-100

  • 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.