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.

On 15 April 1999, physician Gillian Thomas published the editorial “Improved Treatment for Cervical Cancer – Concurrent Chemotherapy and Radiotherapy,” henceforth “Improved Treatment,” in The New England Journal of Medicine. In that editorial, she discusses the potential benefits of combining chemotherapy drugs with radiation to treat women with cervical cancer. At the time, healthcare professionals rarely treated cervical cancer by combining chemotherapy or radiation. Two months prior to Thomas’s publication, the US National Cancer Institute, headquartered in Bethesda, Maryland, released an announcement advocating for combining chemotherapy with radiation based on clinical trial results. In “Improved Treatment,” Thomas summarized the results of those clinical trials that had led to the announcement and communicated a new way to treat invasive cervical cancers, which persists as of 2019.

The United States Food and Drug Administration, or FDA, published 'General Considerations for the Clinical Evaluation of Drugs,' in September 1977. The document defined acceptable practices for investigators who studied new drugs. Specifically, the document outlined the common clinical trial methods. Clinical trials are studies to test whether a new drug is safe before doctors can prescribe it to patients. Prior to 1977, the Protection of Human Subjects Rule primarily regulated clinical drug trials, but it did not specify who could and could not be included in clinical trials. In the document, the FDA recommended that anyone who could become pregnant be excluded from early-phase clinical trials to minimize risks to a potential fetus. After the FDA published the document, investigators excluded women from clinical trials. The document ultimately prevented women of reproductive capacity from participating in early phase clinical trials, which affected women’s health research.