title: Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov.
abstract: OBJECTIVE
  Clinical trials are essential to cancer care, and data about the current state of research in oncology are needed to develop benchmarks and set the stage for improvement.
  
  
  OBJECTIVE
  To perform a comprehensive analysis of the national oncology clinical research portfolio.
  
  
  METHODS
  All interventional clinical studies registered on ClinicalTrials.gov between October 2007 and September 2010 were identified using Medical Subject Heading terms and submitted conditions. They were reviewed to validate classification, subcategorized by cancer type, and stratified by design characteristics to facilitate comparison across cancer types and with other specialties.
  
  
  RESULTS
  Of 40 970 interventional studies registered between October 2007 and September 2010, a total of 8942 (21.8%) focused on oncology. Compared with other specialties, oncology trials were more likely to be single arm (62.3% vs 23.8%; P < .001), open label (87.8% vs 47.3%; P < .001), and nonrandomized (63.9% vs 22.7%; P < .001). There was moderate but significant correlation between number of trials conducted by cancer type and associated incidence and mortality (Spearman rank correlation coefficient, 0.56 [P = .04] and 0.77 [P = .001], respectively). More than one-third of all oncology trials were conducted solely outside North America.
  
  
  CONCLUSIONS
  There are significant variations between clinical trials in oncology and other diseases, as well as among trials within oncology. The differences must be better understood to improve both the impact of cancer research on clinical practice and the use of constrained resources.
authors.affiliation: Duke Cancer Care Research Program, 25165 Morris Bldg, Campus Box 3436, Durham, NC 27710, USA.
authors.forename: Bradford R
authors.initials: BR
authors.lastname: Hirsch
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: Steven K
authors.initials: SK
authors.lastname: Cheng
authors.forename: Asba
authors.initials: A
authors.lastname: Tasneem
authors.forename: John
authors.initials: J
authors.lastname: Horton
authors.forename: Karen
authors.initials: K
authors.lastname: Chiswell
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Schulman
authors.forename: David M
authors.initials: DM
authors.lastname: Dilts
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
mesh_terms: D002986:Clinical Trials as Topic / Q000145:classification* / Q000592:standards*; D016208:Databases, Factual; D006801:Humans; D009369:Neoplasms / Q000628:therapy*