title: Inclusion of minorities and women in cancer clinical trials, a decade later: Have we improved?
abstract: BACKGROUND
  Inclusion of diverse groups of participants in cancer clinical trials is an important methodological and clinical issue. The quality of the science and generalizability of results depends on the inclusion of study participants who represent all populations among whom these treatment and prevention approaches will be used.
  
  
  METHODS
  We conducted a systematic review using OVID as the primary source of reports included. Based on 304 peer-reviewed publications, diversity in the inclusion and reporting of study participants during a decade of cancer treatment and prevention trials (2001-2010) is summarized. Recommendations are made for improvements in the science and reporting of cancer clinical trials.
  
  
  RESULTS
  Of the 277 treatment trials and 27 prevention trials included in this report, more than 80% of participants were white and 59.8% were male. In the recent decade, race and sex are rarely used as selection criteria unless the trial is focused on a sex-specific cancer.
  
  
  CONCLUSIONS
  Women and racial/ethnic minorities remain severely underrepresented in cancer clinical trials, thus limiting the generalizability of cancer clinical research.
authors.affiliation: Richard M. Fairbanks School of Public Health, Indiana University-Purdue University Indianapolis, IN 46202, USA.
authors.forename: Kat
authors.initials: K
authors.lastname: Kwiatkowski
authors.forename: Kathryn
authors.initials: K
authors.lastname: Coe
authors.forename: John C
authors.initials: JC
authors.lastname: Bailar
authors.forename: G Marie
authors.initials: GM
authors.lastname: Swanson
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D008913:Minority Groups; D009369:Neoplasms / Q000628:therapy*
keywords: cancer clinical trials; health disparities; participant selection; prevention; treatment