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Updated: Mar 24, 2026

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
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The Bayesian basket design for genomic variant-driven phase II trials

Richard Simon1, Susan Geyer2, Jyothi Subramanian3

  • 1Division of Cancer Treatment & Diagnosis, National Cancer Institute, 9609 Medical Center Dr, Rockville, MD 20892-9735, USA.

Seminars in Oncology
|March 13, 2016
PubMed

Insights

Basket clinical trials evaluate treatments across various tumor types with specific genomic abnormalities. This study introduces a new design for planning, monitoring, and analyzing these early discovery trials.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Genomics

Background:

  • Basket clinical trials represent a novel approach in early-phase drug development.
  • These trials assess treatments in diverse patient populations defined by specific genomic alterations, irrespective of tumor histology or primary site.

Purpose of the Study:

  • To introduce a robust statistical design for the planning, monitoring, and analysis of basket clinical trials.
  • To facilitate the discovery of specific histologic types that are responsive to a given therapeutic agent.

Main Methods:

  • Development of a novel statistical framework for basket trial design.
  • Implementation of a user-friendly website and software for applying the proposed design.

Main Results:

  • The study presents a comprehensive design applicable to basket clinical trials.
  • Accessible tools (website and software) are provided for researchers to utilize the new design.

Conclusions:

  • The proposed design offers a structured approach to basket trial execution.
  • Further confirmation of findings in histology-specific cohorts is recommended following initial discovery.
Keywords:
Actionable mutationsBasket clinical trialsGenomic clinical trials

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