title: Comparison of survival outcomes among cancer patients treated in and out of clinical trials.
abstract: BACKGROUND
  Clinical trials test the efficacy of a treatment in a select patient population. We examined whether cancer clinical trial patients were similar to nontrial, "real-world" patients with respect to presenting characteristics and survival.
  
  
  METHODS
  We reviewed the SWOG national clinical trials consortium database to identify candidate trials. Demographic factors, stage, and overall survival for patients in the standard arms were compared with nontrial control subjects selected from the Surveillance, Epidemiology, and End Results program. Multivariable survival analyses using Cox regression were conducted. The survival functions from aggregate data across all studies were compared separately by prognosis (≥50% vs <50% average 2-year survival). All statistical tests were two-sided.
  
  
  RESULTS
  We analyzed 21 SWOG studies (11 good prognosis and 10 poor prognosis) comprising 5190 patients enrolled from 1987 to 2007. Trial patients were younger than nontrial patients (P < .001). In multivariable analysis, trial participation was not associated with improved overall survival for all 11 good-prognosis studies but was associated with better survival for nine of 10 poor-prognosis studies (P < .001). The impact of trial participation on overall survival endured for only 1 year.
  
  
  CONCLUSIONS
  Trial participation was associated with better survival in the first year after diagnosis, likely because of eligibility criteria that excluded higher comorbidity patients from trials. Similar survival patterns between trial and nontrial patients after the first year suggest that trial standard arm outcomes are generalizable over the long term and may improve confidence that trial treatment effects will translate to the real-world setting. Reducing eligibility criteria would improve access to clinical trials.
authors.affiliation: Affiliations of authors: SWOG Statistical Center, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, WEB, ML); University of Washington, Department of Health Services Research, Seattle, WA (DPM); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (SDR, RE); Division of Hematology/Oncology, Columbia University, New York, NY (DLH).
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Unger
authors.forename: William E
authors.initials: WE
authors.lastname: Barlow
authors.forename: Diane P
authors.initials: DP
authors.lastname: Martin
authors.forename: Scott D
authors.initials: SD
authors.lastname: Ramsey
authors.forename: Michael
authors.initials: M
authors.lastname: Leblanc
authors.forename: Ruth
authors.initials: R
authors.lastname: Etzioni
authors.forename: Dawn L
authors.initials: DL
authors.lastname: Hershman
mesh_terms: D002173:Cancer Care Facilities; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D006801:Humans; D053208:Kaplan-Meier Estimate; D015999:Multivariate Analysis; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D016017:Odds Ratio; D018579:Patient Selection; D011379:Prognosis; D016016:Proportional Hazards Models; D018426:SEER Program; D015983:Selection Bias; D015996:Survival Rate; D014481:United States / Q000453:epidemiology