Precision oncology: A new era of cancer clinical trials

Lindsay A. Renfro, Ming Wen An, Sumithra J Mandrekar

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Traditionally, site of disease and anatomic staging have been used to define patient populations to be studied in individual cancer clinical trials. In the past decade, however, oncology has become increasingly understood on a cellular and molecular level, with many cancer subtypes being described as a function of biomarkers or tumor genetic mutations. With these changes in the science of oncology have come changes to the way we design and perform clinical trials. Increasingly common are trials tailored to detect enhanced efficacy in a patient subpopulation, e.g. patients with a known biomarker value or whose tumors harbor a specific genetic mutation. Here, we provide an overview of traditional and newer biomarker-based trial designs, and highlight lessons learned through implementation of several ongoing and recently completed trials.

Original languageEnglish (US)
JournalCancer Letters
DOIs
StateAccepted/In press - 2016

Fingerprint

Clinical Trials
Biomarkers
Neoplasms
Mutation
Tumor Biomarkers
Population

Keywords

  • Adaptive design
  • Biomarker-based design
  • Clinical trial
  • Oncology

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Precision oncology : A new era of cancer clinical trials. / Renfro, Lindsay A.; An, Ming Wen; Mandrekar, Sumithra J.

In: Cancer Letters, 2016.

Research output: Contribution to journalArticle

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