More research is needed to understand women’s unique health needs, and it is crucial that women who participate in research studies are informed volunteers. SWHR has advocated for women and minorities to be included more in clinical trials since our inception in 1990.
Milestones in the Inclusion of Women in Research
- 1977- The Food and Drug Administration (FDA) bars women of child bearing potential from participating in most early phase clinical research.
- 1985- A United States Public Health Service task force concludes that exclusion of women from clinical research was detrimental to women’s health.
- 1986- The National Institutes of Health (NIH) adopts guidelines urging the inclusion of women in NIH-sponsored clinical research.
- 1990- The Society for Women’s Health Research is founded and asks the General Accounting Office (GAO) to examine whether NIH is following its 1986 guideline.
- 1990- A GAO report reveals that the NIH guidelines are not being followed. The Physician’s Health or “aspirin” study, designed to examine the impact of taking aspirin on cardiovascular disease, is one of many large studies not included women highlighted by the report.
- 1993- The NIH Revitalization Act of 1993 mandates that the NIH must ensure that women and members of minorities and their subpopulations are included in all human subject research.
- 1993-The FDA rescinds earlier guidelines barring the participation of women with child-bearing potential from most early phase research.
- 2000- The GAO concludes that although women are now included in clinical research proportionate to their representation in the population, analysis by sex of subjects is rare.
- 2001- The GAO concludes FDA not effectively monitoring research data to determine how sex differences affect drug safety and effectiveness.
- 2006- The Organization for the Study of Sex Differences is established. It is the brain child of basic and clinical scientists with established research commitments to the study of sex differences, and staff members of (SWHR).
- 2012- Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) signed into law, requiring FDA to provide a special report and accounting of trials by sex, race, and ethnicity.
- 2014 – The National Institutes of Health (NIH) enact new policies to address sex differences by will be requiring applicants to report their cell and animal inclusion plans as part of preclinical experimental design.
- 2015– The FDA launched the website Drug Trials Snapshots that provide consumers with information about who participated in clinical trials that supported the FDA approval of new drugs. The site is is part of an overall FDA effort to make demographic data more available and transparent.