Women comprised over 61% of NIH human research subjects in FY 2000

Women comprised over 61% of NIH human research subjects in FY 2000

Females represented 61.3% of research participants in all NIH-funded extramural human studies in FY 2000, and 70.9% in Phase III clinical trials, according to data compiled by the NIH Tracking and Inclusion Committee, which traces enrollment of women and members of minority racial groups in NIH-funded research. In a report released Jan. 7, the committee documents over 5.9 million female and 3.7 million male participants in all NIH human studies in FY 2000, compared to 4.5 million and 2.8 million, respectively, in FY 1999. Enrollment percentages in all human research were similar to those in FY 1999 -- 61.6% women and 37.7% men.

The NIH Inclusion and Tracking Committee was formed after the 1993 NIH Revitalization Act was passed to ensure NIH-funded research protocols adhere to policy on the inclusion of women and minorities in clinical trials. The law stipulates those two populations be included in all clinical research, including in Phase III studies.

In FY 2000 Phase III studies, 412,379 women versus 168,085 men participated. Compared with FY 1999 totals, female participants increased from 313,952, but male participants decreased from 180,705. If sex-specific human studies are excluded from the totals, the percentages of men and women who participate in NIH-funded research are roughly equal. The committee's data indicate the number of funded research protocols enrolling both women and men was 5,542, including 411Phase III trials. For gender-specific studies, 975 targeted women exclusively, including 121 Phase III studies, while 360 protocolswere men-only (34 Phase III). The unequal gender distribution of research participants may be appropriate to the extent that women carry a larger chronic disease burden and take more medications than men.

Aggregate data for all FY 2000 extramural research indicate non-Hispanic whites represent the largest percentage of research participants (62.4%), followed by people of Asian or Pacific Island descent (11.4%), African-Americans (11.3%) and Hispanics (7.9%). Within minority racial groups, the gender breakdowns roughly parallel the overall male/female division.

Source: Washington Fax, January 9, 2003