title: Enrollment of women and minorities in NINDS trials.
abstract: OBJECTIVE
  To determine policy-associated changes over time in 1) the enrollment of women and minorities in National Institute of Neurological Disorders and Stroke (NINDS)-funded clinical trials and 2) the trial publication reporting of race/ethnicity and gender.
  
  
  METHODS
  All NINDS-funded phase III trials published between 1985 and 2008 were identified. Percent of African Americans, Hispanic Americans, and women enrolled in the trials was calculated for those trials with available data. Z tests were used to compare reporting and enrollment data from before (period 1) and after (period 2) 1995 when NIH enacted their policies regarding race, ethnicity, and gender. Percent of main trial publications reporting enrollment of African Americans, Hispanic Americans, and women was also calculated.
  
  
  RESULTS
  Of the 56 trials identified, 100%, 48%, and 25% reported enrollment by gender, race, and ethnicity. Women constituted 42.1% of the trial population. Enrollment of women increased over time (36.9% period 1; 49.0% period 2, p < 0.001). African Americans constituted 19.8% of the enrollees in trials with available data and enrollment increased over time (11.6% period 1; 30.7% period 2, p < 0.001). Hispanic Americans constituted 5.8% of subjects in trials with available data and enrollment decreased over time (7.4% period 1; 5.0% period 2, p < 0.001).
  
  
  CONCLUSIONS
  Improvements in reporting of race/ethnicity in publications and enrollment of Hispanics in NINDS trials are needed. While African American representation is above population levels, Hispanic Americans are underrepresented in NINDS trials and representation is declining despite Hispanics' increasing representation in the US population.
authors.affiliation: Stroke Program, University of Michigan Medical School, Ann Arbor, MI 48109-5855, USA.
authors.forename: J F
authors.initials: JF
authors.lastname: Burke
authors.forename: D L
authors.initials: DL
authors.lastname: Brown
authors.forename: L D
authors.initials: LD
authors.lastname: Lisabeth
authors.forename: B N
authors.initials: BN
authors.lastname: Sanchez
authors.forename: L B
authors.initials: LB
authors.lastname: Morgenstern
mesh_terms: D001741:Black or African American; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D008297:Male; D055825:National Institute of Neurological Disorders and Stroke (U.S.); D018579:Patient Selection; D014481:United States; D014930:Women