title: Identifying barriers associated with enrollment of patients with lung cancer into clinical trials.
abstract: BACKGROUND
  Enrollment of patients with lung cancer into clinical trials is required to accelerate the pace of new therapy development and contribute to a better understanding of the biological characteristics of cancer.
  
  
  METHODS
  We conducted a retrospective chart review of all patients seen by the thoracic medical oncology team at the Vanderbilt Ingram Cancer Center (VICC) from November 2005 to November 2008 to determine the barriers associated with patient enrollment in to clinical trials.
  
  
  RESULTS
  One thousand forty-three patient charts were audited: 32% of patients were eligible for enrollment, and 14% enrolled in a study. There were no significant differences in protocol availability or eligibility by sex, smoking status, or age. Patients living further from the cancer center were significantly less likely to have a study protocol available (P = .009), but if a protocol was available they were more likely to be eligible for enrollment (P < .001). Significantly more protocols were available for patients with non-small-cell lung cancer (NSCLC) compared with those who had small-cell lung cancer (SCLC) (63% vs. 48%; P < .001). Patients with advanced disease were more likely to have a protocol available (P < .001) and enter a study (P = .031). The most common reasons for patients not being eligible for enrollment were poor performance status (32%) and presence of comorbid disease (27%). The most common reasons for potentially eligible patients not enrolling in a study included preference for treatment closer to home (49%) and patient refusal (43%).
  
  
  CONCLUSIONS
  Additional strategies are required to increase accrual of patients into lung cancer trials, including development of protocols for early-stage disease and modifying eligibility and performance status criteria for this unique patient population.
authors.affiliation: Vanderbilt Ingram Cancer Center, Nashville, TN 37232, USA. leora.horn@vanderbilt.edu
authors.forename: Leora
authors.initials: L
authors.lastname: Horn
authors.forename: Vicki L
authors.initials: VL
authors.lastname: Keedy
authors.forename: Norma
authors.initials: N
authors.lastname: Campbell
authors.forename: Gabe
authors.initials: G
authors.lastname: Garcia
authors.forename: Amy
authors.initials: A
authors.lastname: Hayes
authors.forename: Brady
authors.initials: B
authors.lastname: Spencer
authors.forename: David P
authors.initials: DP
authors.lastname: Carbone
authors.forename: Alan
authors.initials: A
authors.lastname: Sandler
authors.forename: David H
authors.initials: DH
authors.lastname: Johnson
mesh_terms: D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic; D015897:Comorbidity; D004608:Eligibility Determination; D005260:Female; D006297:Health Services Accessibility; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D012189:Retrospective Studies; D012720:Severity of Illness Index; D055752:Small Cell Lung Carcinoma / Q000473:pathology / Q000628:therapy*; D018709:Statistics, Nonparametric; D016312:Treatment Refusal