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.
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: R L Sacco; B Boden-Albala; R Gan; X Chen; D E Kargman; S Shea; M C Paik; W A Hauser Journal: Am J Epidemiol Date: 1998-02-01 Impact factor: 4.897
Authors: R Mayeux; K Marder; L J Cote; J Denaro; N Hemenegildo; H Mejia; M X Tang; R Lantigua; D Wilder; B Gurland Journal: Am J Epidemiol Date: 1995-10-15 Impact factor: 4.897
Authors: J Broderick; T Brott; R Kothari; R Miller; J Khoury; A Pancioli; J Gebel; D Mills; L Minneci; R Shukla Journal: Stroke Date: 1998-02 Impact factor: 7.914
Authors: Gaston Djomand; Joanna Katzman; Dante di Tommaso; Michael G Hudgens; George W Counts; Beryl A Koblin; Patrick S Sullivan Journal: Public Health Rep Date: 2005 Sep-Oct Impact factor: 2.792
Authors: Lewis B Morgenstern; Melinda A Smith; Lynda D Lisabeth; Jan M H Risser; Ken Uchino; Nelda Garcia; Paxton J Longwell; David A McFarling; Olubumi Akuwumi; Areej Al-Wabil; Fahmi Al-Senani; Devin L Brown; Lemuel A Moyé Journal: Am J Epidemiol Date: 2004-08-15 Impact factor: 4.897
Authors: Barbara C Tilley; Arch G Mainous; Daniel W Smith; M Diane McKee; Rossybelle P Amorrortu; Jennifer Alvidrez; Vanessa Diaz; Marvella E Ford; Maria E Fernandez; Robert A Hauser; Carlos Singer; Veronica Landa; Aron Trevino; Stacia M DeSantis; Yefei Zhang; Elvan Daniels; Derrick Tabor; Sally W Vernon Journal: Clin Trials Date: 2017-03-19 Impact factor: 2.486
Authors: Timea Hodics; Leonardo G Cohen; John C Pezzullo; Karen Kowalske; Alexander W Dromerick Journal: Neurorehabil Neural Repair Date: 2022-08-04 Impact factor: 4.895
Authors: Alice J Sheffet; George Howard; Albert Sam; Zafar Jamil; Fred Weaver; David Chiu; Jenifer H Voeks; Virginia J Howard; Susan E Hughes; Linda Flaxman; Mary E Longbottom; Thomas G Brott Journal: Stroke Date: 2017-11-30 Impact factor: 7.914
Authors: Karen Lane; Maningbe Keita; Radhika Avadhani; Rachel Dlugash; Steven Mayo; Richard E Thompson; Issam Awad; Nichol McBee; Wendy Ziai; Daniel F Hanley Journal: Clin Res (Alex) Date: 2018-08-14
Authors: Logan R Thornton; Rossybelle P Amorrortu; Daniel W Smith; Arch G Mainous; Sally W Vernon; Barbara C Tilley Journal: Contemp Clin Trials Commun Date: 2016-06-24