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. 2011 Jan 25;76(4):354-60.
doi: 10.1212/WNL.0b013e3182088260. Epub 2011 Jan 5.

Enrollment of women and minorities in NINDS trials

J F Burke  1 , D L Brown, L D Lisabeth, B N Sanchez, L B Morgenstern
Affiliations

Enrollment of women and minorities in NINDS trials

J F Burke et al. Neurology. .

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.

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Figures

Figure
Figure. Sensitivity analysis
Results of one-way sensitivity analysis to assess the extent to which nonreporting of race/ethnicity in some trials could affect the estimated minority enrollment across all National Institute of Neurological Disorders and Stroke phase III trials. Assumed enrollment rates for nonreporting trials are varied from 0% to 200% of the average enrollment of all trials that reported race/ethnicity information. 1) The African American percentage of the population as of the 2000 US census was 12.9%. 2) The Hispanic percentage of the population as of the 2000 US census was 12.5%.
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References

    1. Reeves MJ, Bushnell CD, Howard G, et al. Sex differences in stroke: epidemiology, clinical presentation, medical care, and outcomes. Lancet Neurol 2008;7:915–926 - PMC - PubMed
    1. Morgenstern LB, Smith MA, Lisabeth LD, et al. Excess stroke in Mexican Americans compared with non-Hispanic whites: the Brain Attack Surveillance in Corpus Christi Project. Am J Epidemiol 2004;160:376–383 - PMC - PubMed
    1. Broderick J, Brott T, Kothari R, et al. The Greater Cincinnati/Northern Kentucky Stroke Study: preliminary first-ever and total incidence rates of stroke among blacks. Stroke 1998;29:415–421 - PubMed
    1. Sacco R, Boden-Albala B, Gan R, Chen X. Stroke incidence among white, black and Hispanic residents of an urban community. Am J Epidemiol 1998;147:259–268 - PubMed
    1. Bracken MB DHF, Jr, Hellenbrand K. Incidence of acute traumatic hospitalized spinal cord injury in the United States, 1970–1977. Am J Epidemiol 1981;113:615–622 - PubMed