title: Cancer trials versus the real world in the United States.
abstract: BACKGROUND
  Federal policies have been implemented to mitigate underenrollment in cancer trials in the United States. We sought to identify patterns and predictors of enrollment patterns to cancer trials in a contemporary era using a real world setting.
  
  
  METHODS
  The 2001-2008 California Cancer Registry was used to determine patterns and predictors of enrollment in clinical trials for stage 0 to IV solid organ malignant tumors. Multivariate techniques were used to identify predictors of enrollment in cancer protocols, controlling for covariates.
  
  
  RESULTS
  Less than a percent (0.64%) of patients enrolled in clinical trials (1566 of 244,528). Black patients were less likely than whites to enroll in trials (0.48% vs 0.67%, P < 0.05). On multivariate analysis, older persons (>65 years), early stage cancer, and those with lung or gastrointestinal cancers were less likely to be enrolled in cancer trials. Results were consistent when evaluated among only nonbreast cancer protocols. Though approaching significance, black, underinsured, and uninsured patients showed trends toward underenrollment.
  
  
  CONCLUSIONS
  In addition to profoundly low overall cancer trial accrual, vast underrepresentation by age, cancer stage, and site continue to exist. The generalizability of these trials to a real world perspective remains an open question. Physicians, payers, the National Cancer Institute, and other stakeholders need to develop broader cancer trials to benefit the millions of patients with cancer in the United States.
authors.affiliation: Department of Surgery, University of Minnesota, Minneapolis, Minnesota 55455, USA. alref003@umn.edu
authors.forename: Waddah B
authors.initials: WB
authors.lastname: Al-Refaie
authors.forename: Selwyn M
authors.initials: SM
authors.lastname: Vickers
authors.forename: Wei
authors.initials: W
authors.lastname: Zhong
authors.forename: Helen
authors.initials: H
authors.lastname: Parsons
authors.forename: David
authors.initials: D
authors.lastname: Rothenberger
authors.forename: Elizabeth B
authors.initials: EB
authors.lastname: Habermann
mesh_terms: D001741:Black or African American / Q000706:statistics & numerical data*; D017677:Age Distribution; D000368:Aged; D002140:California / Q000453:epidemiology; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D015331:Cohort Studies; D005260:Female; D006297:Health Services Accessibility; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D009369:Neoplasms / Q000208:ethnology* / Q000473:pathology / Q000628:therapy; D018579:Patient Selection; D011203:Poverty; D012189:Retrospective Studies; D012307:Risk Factors; D044465:White People / Q000706:statistics & numerical data*