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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.