Phase II cancer clinical trials for biomarker-guided treatments.

Journal Article (Journal Article)

The design and analysis of cancer clinical trials with biomarker depend on various factors, such as the phase of trials, the type of biomarker, whether the used biomarker is validated or not, and the study objectives. In this article, we demonstrate the design and analysis of two Phase II cancer clinical trials, one with a predictive biomarker and the other with an imaging prognostic biomarker. Statistical testing methods and their sample size calculation methods are presented for each trial. We assume that the primary endpoint of these trials is a time to event variable, but this concept can be used for any type of endpoint.

Full Text

Duke Authors

Cited Authors

  • Jung, S-H

Published Date

  • 2018

Published In

Volume / Issue

  • 28 / 2

Start / End Page

  • 256 - 263

PubMed ID

  • 28902567

Pubmed Central ID

  • PMC5842127

Electronic International Standard Serial Number (EISSN)

  • 1520-5711

Digital Object Identifier (DOI)

  • 10.1080/10543406.2017.1372777


  • eng

Conference Location

  • England