Basket Studies: Redefining Clinical Trials in the Era of Genome-Driven Oncology

Jessica J. Tao, Alison M. Schram, David M. Hyman

Research output: Contribution to journalArticlepeer-review

Abstract

Understanding a tumor's detailed molecular profile has become increasingly necessary to deliver the standard of care for patients with advanced cancer. Innovations in both tumor genomic sequencing technology and the development of drugs that target molecular alterations have fueled recent gains in genome-driven oncology care. "Basket studies," or histology-agnostic clinical trials in genomically selected patients, represent one important research tool to continue making progress in this field. We review key aspects of genome-driven oncology care, including the purpose and utility of basket studies, biostatistical considerations in trial design, genomic knowledgebase development, and patient matching and enrollment models, which are critical for translating our genomic knowledge into clinically meaningful outcomes.

Original languageEnglish (US)
Pages (from-to)319-331
Number of pages13
JournalAnnual review of medicine
Volume69
DOIs
StatePublished - Jan 29 2018
Externally publishedYes

Keywords

  • Basket study
  • Basket trial
  • Genome-driven oncology
  • Knowledgebase
  • Precision medicine

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

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