title: Enrollment and Racial Disparities in Cancer Treatment Clinical Trials in North Carolina.
abstract: BACKGROUND
  Clinical trials provide access to innovative, high-quality cancer treatment. Simultaneously, broad access helps to ensure that trials include heterogeneous patient populations, which improves the generalizability of findings and the development of interventions that are effective for diverse populations. We provide updated data describing enrollment into cancer treatment trials in North Carolina.
  
  
  METHODS
  For the period 1996-2009, person-level data regarding cancer clinical trial enrollment and cancer incidence were obtained from the North Carolina Central Cancer Registry and the National Cancer Institute (NCI). Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for race, sex, and year for each county, Area Health Education Center region, and the state overall. Enrollment rates for common cancers are presented.
  
  
  RESULTS
  From 1996 to 2009, North Carolina NCI treatment trial enrollment rates were 2.4% and 2.2% for white patients and minority patients, respectively. From 2007 to 2009, rates were 3.8% for white women, 3.5% for minority women, 1.3% for white men, and 1.0% for minority men; there was greater enrollment among more urban populations (2.4%) than among the most rural populations (1.5%).
  
  
  CONCLUSIONS
  This study is limited to NCI-sponsored treatment trials in North Carolina. Policies governing collection of original data necessitate a delay in data availability.
  
  
  CONCLUSIONS
  Effort is needed to ensure trial access and enrollment among all North Carolina populations. Specifically, we identified racial and sex disparities, particularly for certain cancers (eg, breast cancer). Programs in North Carolina and across the nation can use the methods we employed to assess their success in broadening clinical trial enrollment to include diverse populations.
authors.affiliation: research health science specialist, Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, North Carolina; adjunct assistant professor, Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina; assistant professor, Department of Medicine and Duke Cancer Institute, Duke University, Durham, North Carolina.
authors.forename: Leah L
authors.initials: LL
authors.lastname: Zullig
authors.affiliation: postdoctoral fellow, Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, North Carolina.
authors.forename: Alice G
authors.initials: AG
authors.lastname: Fortune-Britt
authors.affiliation: researcher, Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
authors.forename: Shangbang
authors.initials: S
authors.lastname: Rao
authors.affiliation: applications specialist, Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
authors.forename: Seth D
authors.initials: SD
authors.lastname: Tyree
authors.affiliation: professor, Department of Medicine, University of North Carolina at Chapel Hill; member and principal investigator, UNC-Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Godley
authors.affiliation: adjunct associate professor, Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina; senior research mentor, UNC-Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina bill.carpenter@unc.edu.
authors.forename: William R
authors.initials: WR
authors.lastname: Carpenter
mesh_terms: D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D005006:Ethnicity / Q000706:statistics & numerical data*; D005260:Female; D054625:Healthcare Disparities; D006801:Humans; D008297:Male; D008875:Middle Aged; D008913:Minority Groups / Q000706:statistics & numerical data*; D009369:Neoplasms / Q000188:drug therapy* / Q000208:ethnology; D009657:North Carolina; D018579:Patient Selection; D063505:Racism; D012959:Socioeconomic Factors