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Updated: Mar 24, 2026
05:53
Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
Published on: June 21, 2018
10.8K
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
Summary
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.
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