Stroke Program, University of Michigan Medical School, Ann Arbor, MI 48109-5855, USA.
Neurology. 2011 Jan 25;76(4):354-60. doi: 10.1212/WNL.0b013e3182088260. Epub 2011 Jan 5.
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.
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.
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).
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.
确定 1）国家神经疾病与卒中研究所（NINDS）资助的临床试验中女性和少数族裔的入组情况，以及 2）种族/民族和性别报告在临床试验中的变化趋势是否与政策相关。
确定了 1985 年至 2008 年间发表的所有 NINDS 资助的 III 期临床试验。对于有可用数据的试验，计算了试验中纳入的非裔美国人、西班牙裔美国人和女性的百分比。采用 Z 检验比较了 1995 年 NIH 制定有关种族、民族和性别政策之前（第 1 期）和之后（第 2 期）的报告和入组数据。还计算了主要试验出版物报告纳入非裔美国人、西班牙裔美国人和女性的百分比。
在确定的 56 项试验中，有 100%、48%和 25%报告了性别、种族和民族的入组情况。女性占试验人群的 42.1%。女性入组人数随时间增加（第 1 期 36.9%；第 2 期 49.0%，p<0.001）。在有可用数据的试验中，非裔美国人占入组人数的 19.8%，且入组人数随时间增加（第 1 期 11.6%；第 2 期 30.7%，p<0.001）。在有可用数据的试验中，西班牙裔美国人占受试者的 5.8%，且入组人数随时间减少（第 1 期 7.4%；第 2 期 5.0%，p<0.001）。
需要改进出版物中种族/民族的报告和 NINDS 试验中西班牙裔美国人的入组情况。虽然非裔美国人的代表性高于人口水平，但西班牙裔美国人在 NINDS 试验中的代表性不足，而且尽管西班牙裔在美国人口中的比例不断增加，但代表性却在下降。
