Clinical trials: Early phase clinical trials-are dose expansion cohorts needed?

Nat Rev Clin Oncol. 2015 Nov;12(11):626-8. doi: 10.1038/nrclinonc.2015.174. Epub 2015 Oct 6.

Abstract

Dose-expansion cohorts (DECs) enable investigators to identify potentially effective drugs, for specific patient populations, in a single trial by assessing antitumour activity as early as possible. We discuss how the objectives, design and interpretation of DEC have evolved, and how DECs are changing the landscape of early drug development.

Publication types

  • News
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / therapeutic use
  • Clinical Trials, Phase I as Topic / statistics & numerical data*
  • Cohort Studies*
  • Humans
  • Maximum Tolerated Dose
  • Neoplasms / drug therapy*
  • Randomized Controlled Trials as Topic
  • Sample Size

Substances

  • Antineoplastic Agents