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Basket Designs: Statistical Considerations for Oncology Trials

Alexander M Kaizer1, Joseph S Koopmeiners2, Michael J Kane3

  • 1University of Colorado Anschutz Medical Campus, Aurora, CO.

JCO Precision Oncology
|February 1, 2022
PubMed

Insights

Master protocols, including basket trials, enhance oncology clinical research efficiency. These innovative designs accelerate drug development by evaluating multiple therapies across various patient subgroups with common molecular targets.

Area of Science:

  • Oncology
  • Clinical Research
  • Genomics

Background:

  • Genomic advancements and drug discovery have propelled translational cancer research.
  • Master protocols, featuring inclusive criteria, are increasingly used in oncology clinical trials.
  • These protocols efficiently test multiple therapies for specific tumor types or across histologies.

Purpose of the Study:

  • To review basket trial designs in oncology.
  • To discuss challenges in the design and analysis of basket trials.

Main Methods:

  • Basket trials evaluate treatment efficacy in patient subpopulations with a shared molecular target.
  • These trials are commonly conducted in the phase II setting.
  • They aim to identify preliminary efficacy signals for promising preclinical indications.

Main Results:

  • Basket trials facilitate the evaluation of targeted therapies across diverse cancer types.
  • They offer a structured approach to identifying potential drug benefits in specific molecularly defined groups.
  • The article reviews design considerations and analytical issues pertinent to basket trials.

Conclusions:

  • Basket trials represent a key innovation in oncology clinical research, improving efficiency.
  • Their design allows for the investigation of targeted therapies in molecularly selected patient groups.
  • Addressing design and analysis challenges is crucial for maximizing the utility of basket trials.

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