title: Differences in clinical trial patient attributes and outcomes according to enrollment setting.
abstract: OBJECTIVE
  During the last 25 years, National Cancer Institute (NCI) cooperative trial groups have extended trial networks from academic centers to include certain community and Veterans Health Administration (VHA) centers. We compared trial patients' attributes and outcomes by these enrollment settings.
  
  
  METHODS
  Studying 2,708 patients on one of 10 cooperative group, randomized lung trials at 272 institutions, we compared patient attributes by enrollment setting (ie, academic, community, and VHA affiliates). We used adjusted Cox regression to evaluate for survival differences by setting.
  
  
  RESULTS
  Main member institutions enrolled 44% of patients; community affiliates enrolled 44%; and VHAs enrolled 12%. Patient attributes (ie, case-mix) of age, ethnicity, sex, and performance status varied by enrollment setting. After analysis was adjusted for patient case-mix, no mortality differences by enrollment setting were noted.
  
  
  CONCLUSIONS
  Although trial patients with primarily advanced-stage lung cancer from nonacademic centers were older and had worse performance statuses than those from academic centers, survival did not differ by enrollment setting after analysis accounted for patient heterogeneity. An answer for whether long-term outcomes for patients at community and VHA centers affiliated with cooperative trial groups are equivalent to those at academic centers when care is delivered through NCI trials requires additional research among patients with longer survival horizons.
authors.affiliation: Dept of Health Care Policy, Harvard Medical School, 180A Longwood Ave, Boston, MA 02115, USA. lamont@hcp.med.harvard.edu
authors.forename: Elizabeth B
authors.initials: EB
authors.lastname: Lamont
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Landrum
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Keating
authors.forename: Laura
authors.initials: L
authors.lastname: Archer
authors.forename: Lan
authors.initials: L
authors.lastname: Lan
authors.forename: Gary M
authors.initials: GM
authors.lastname: Strauss
authors.forename: Rogerio
authors.initials: R
authors.lastname: Lilenbaum
authors.forename: Harvey B
authors.initials: HB
authors.lastname: Niell
authors.forename: L Herbert
authors.initials: LH
authors.lastname: Maurer
authors.forename: Michael P
authors.initials: MP
authors.lastname: Kosty
authors.forename: Antonius A
authors.initials: AA
authors.lastname: Miller
authors.forename: Gerald H
authors.initials: GH
authors.lastname: Clamon
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Elias
authors.forename: Edward F
authors.initials: EF
authors.lastname: McClay
authors.forename: Everett E
authors.initials: EE
authors.lastname: Vokes
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: McNeil
mesh_terms: D000046:Academic Medical Centers; D002986:Clinical Trials as Topic; D003153:Community Health Services; D006268:Health Facilities; D006787:Hospitals, Veterans; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D005791:Patient Care / Q000592:standards*; D018579:Patient Selection; D011787:Quality of Health Care; D016896:Treatment Outcome