title: The impact of insurance on access to cancer clinical trials at a comprehensive cancer center.
abstract: OBJECTIVE
  Cancer patients at Johns Hopkins undergo insurance clearance to verify coverage for enrollment to interventional clinical trials. We sought to explore the impact of insurance clearance on disparities in access to cancer clinical trials at this urban comprehensive cancer center.
  
  
  METHODS
  We evaluated the frequency of insurance-based denial of access to cancer clinical trials over a 5-year period after initiation of a formal insurance clearance process. We used a case-control design to compare demographic and clinical parameters of patients denied or approved for clinical trials participation by their insurance company in a 3-year interval.
  
  
  RESULTS
  From July 2003 to July 2008, insurance requests for clinical trial participation were submitted on 4,617 consented cancer patients at Johns Hopkins. A total of 628 patients (13.6%) with health insurance were denied therapeutic trial enrollment owing to lack of insurance coverage for participation. A total of 254 patients denied enrollment from 2005 to 2007 were selected for further analysis. Two-hundred sixty randomly selected patients approved for clinical trial participation served as controls. Patients approved were on average older (59.2 versus 54.9 years) than patients denied (P = 0.0001). Residents of Pennsylvania, which lacks a state law mandating cancer clinical trial coverage for residents, were overrepresented among the denied patients (P = 0.0009). No statistically significant variance in the likelihood of insurance denial was found on the basis of sex, race, stage of disease, or presence of comorbidities.
  
  
  CONCLUSIONS
  Denial of access to therapeutic clinical trials, even among insured patients, is a significant barrier to clinical cancer research. This barrier spans racial, ethnic, and gender categories.
authors.affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231, USA.
authors.forename: Justin F
authors.initials: JF
authors.lastname: Klamerus
authors.forename: Suanna S
authors.initials: SS
authors.lastname: Bruinooge
authors.forename: Xiaobu
authors.initials: X
authors.lastname: Ye
authors.forename: Mandi L
authors.initials: ML
authors.lastname: Klamerus
authors.forename: Dorothy
authors.initials: D
authors.lastname: Damron
authors.forename: Dina
authors.initials: D
authors.lastname: Lansey
authors.forename: John C
authors.initials: JC
authors.lastname: Lowery
authors.forename: Luis A
authors.initials: LA
authors.lastname: Diaz
authors.forename: Jean G
authors.initials: JG
authors.lastname: Ford
authors.forename: Norma
authors.initials: N
authors.lastname: Kanarek
authors.forename: Charles M
authors.initials: CM
authors.lastname: Rudin
mesh_terms: D002173:Cancer Care Facilities / Q000191:economics; D003191:Comprehensive Health Care / Q000191:economics*; D005006:Ethnicity / Q000706:statistics & numerical data; D005260:Female; D005843:Geography; D006297:Health Services Accessibility / Q000191:economics*; D006801:Humans; D019458:Insurance Coverage / Q000191:economics*; D007348:Insurance, Health / Q000191:economics; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000191:economics* / Q000208:ethnology / Q000628:therapy; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000191:economics; D012923:Social Class; D014481:United States