[Phases 0, 1 and 2 oncology clinical trials: current questions]

Bull Cancer. 2010 Jan;97(1):55-63. doi: 10.1684/bdc.2010.1016.
[Article in French]

Abstract

We propose here a general review of current questions related to early trials, including the choice of the primary endpoint, role of bayesian designs, role of stratification and randomization for phase 2 trials, patient selection, and new designs for phase 1 and phase 0 trials. We also discuss the difficulties to apply such methodologies to molecular targeted therapies development.

Publication types

  • English Abstract
  • Review

MeSH terms

  • Antineoplastic Agents / therapeutic use
  • Bayes Theorem
  • Clinical Trials as Topic / methods*
  • Clinical Trials as Topic / standards
  • Clinical Trials, Phase I as Topic / methods
  • Clinical Trials, Phase I as Topic / standards
  • Clinical Trials, Phase II as Topic / methods
  • Clinical Trials, Phase II as Topic / standards
  • Decision Theory
  • Drug Screening Assays, Antitumor / methods
  • Drug Screening Assays, Antitumor / standards
  • Humans
  • Neoplasms / therapy*
  • Patient Selection
  • Randomized Controlled Trials as Topic / methods
  • Randomized Controlled Trials as Topic / standards
  • Treatment Outcome

Substances

  • Antineoplastic Agents