title: Design of oncology clinical trials: a review.
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.
authors.affiliation: 3 Everett Street, #3, Cambridge, MA 02138, USA. Electronic address: revathia@gmail.com.
authors.forename: Revathi
authors.initials: R
authors.lastname: Ananthakrishnan
authors.forename: Sandeep
authors.initials: S
authors.lastname: Menon
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D012107:Research Design / Q000592:standards
keywords: II and III oncology clinical trials; PK/PD modeling; Phases I; Safety and efficacy endpoints; Statistical analyses; Trial designs