The US Food and Drug Administration, or FDA, published the “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” henceforth “Study of Gender Differences,” in July 1993. The document defined acceptable practices for investigators studying new drugs. Prior to 1993, investigators excluded most women from clinical trials because in 1977, the FDA recommended that anyone who could possibly become pregnant be excluded from early phase drug research to minimize risk to a potential fetus. In 1997, the FDA reversed that guidance, advising investigators to include women in early phase drug research, a decision that reflected changing views about a woman’s ability to decide whether to participate in drug trials and furthering research on the effects of drugs on women.

In 2000, Marcia Killien and colleagues published “Involving Minority and Underrepresented Women in Clinical Trials: The National Centers of Excellence in Women’s Health,” hereafter “Involving Women,” in the Journal of Women’s Health and Gender-Based Medicine. Killien and colleagues address the historical exclusion of women from participation in medical research studies and difficulties in generalizing the results of studies that exclude women. They propose strategies to improve participation of minority and underrepresented women in clinical studies and identify systemic barriers such as mistrust, lack of access, and cultural insensitivity that have historically excluded those populations from clinical trials. The article emphasizes the necessity of inclusive research to ensure that medical advancements benefit all women equitably and suggests strategies to achieve more inclusive clinical research practices.