Design of oncology clinical trials: a review

Crit Rev Oncol Hematol. 2013 Oct;88(1):144-53. doi: 10.1016/j.critrevonc.2013.03.007. Epub 2013 Apr 25.


Cancer is a disease that occurs due to the uncontrolled multiplication of cells that invade nearby tissues and can spread to other parts of the body. An increased incidence of cancer in the world has led to an increase in oncology research and in the number of oncology trials. Well designed oncology clinical trials are a key part of developing effective anti-cancer drugs. This review focuses on statistical considerations in the design and analysis of oncology clinical trials.

Keywords: II and III oncology clinical trials; PK/PD modeling; Phases I; Safety and efficacy endpoints; Statistical analyses; Trial designs.

Publication types

  • Review

MeSH terms

  • Clinical Trials as Topic* / standards
  • Clinical Trials, Phase I as Topic
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Humans
  • Neoplasms / drug therapy*
  • Research Design* / standards