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An overview of precision oncology basket and umbrella trials for clinicians

Jay J H Park1, Grace Hsu2, Ellie G Siden1

  • 1Experimental Medicine, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.

CA: a Cancer Journal for Clinicians
|February 8, 2020
PubMed

Insights

Master protocols, including basket and umbrella trials, improve clinical trial efficiency for precision medicine. These biomarker-guided studies evaluate targeted therapies across diseases or within a single disease, tailoring treatments to patient risk factors.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Biomarker Research

Background:

  • Advancements in biomarkers and precision medicine have led to the development of master protocols.
  • Master protocols, such as basket and umbrella trials, aim to enhance the efficiency of evaluating multiple hypotheses.
  • These trials are crucial for tailoring interventions based on predictive patient risk factors.

Purpose of the Study:

  • To review the common characteristics of basket and umbrella trials.
  • To highlight key trials and recent FDA approvals in precision oncology.
  • To provide considerations for evaluating and designing these master protocol trials.

Main Methods:

  • Review of existing literature and clinical trial designs.
  • Analysis of characteristics differentiating basket and umbrella trials.
  • Examination of recent US Food and Drug Administration (FDA) approvals in precision oncology.

Main Results:

  • Basket trials evaluate one targeted therapy across multiple diseases with shared molecular alterations.
  • Umbrella trials assess multiple targeted therapies within one disease, stratified by molecular subgroups.
  • Both designs embody precision medicine principles by matching treatments to patient-specific factors.

Conclusions:

  • Basket and umbrella trials represent significant advancements in master protocol frameworks for precision oncology.
  • Despite increasing use, these trial designs are often poorly understood by clinicians and researchers.
  • Critical evaluation and thoughtful design are essential for maximizing the impact of these innovative trials.
Keywords:
basket trialsmaster protocolsprecision medicineprecision oncologyumbrella trials

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