Design of oncology clinical trials: a review

Revathi Ananthakrishnan; Sandeep Menon

doi:10.1016/j.critrevonc.2013.03.007

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.

Authors

Revathi Ananthakrishnan¹, Sandeep Menon

Affiliation

¹ 3 Everett Street, #3, Cambridge, MA 02138, USA. Electronic address: revathia@gmail.com.

PMID: 23623356
DOI: 10.1016/j.critrevonc.2013.03.007

Abstract

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