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.
In 2001, David Kimberlin and colleagues published “Natural History of Neonatal Herpes Simplex Virus Infections in Acyclovir Era,” hereafter, “Natural History of Herpes,” in the journal Pediatrics. In the article, the researchers explore the natural history of herpes, which entails asking how herpes simplex virus, or HSV, progresses in infants when treated with acyclovir, one of the first antiviral medications that effectively treated HSV in adults. HSV can cause painful lesions on the mouth or genitals. When infants contract HSV, it can cause life-threatening illness, including skin lesions, blindness, developmental delays, and often death. At the time of publication, researchers and physicians had evidence that acyclovir could effectively treat neonatal HSV, but physicians still struggled to address the condition quickly enough to improve treatment outcomes. “Natural History of Herpes” presents an updated picture, as of 2001, of how HSV progresses to provide physicians with quicker ways to identify the condition in neonates, who frequently contract the disease from their mothers in utero or during labor and delivery.
In 2020, Rebecca Flyckt and colleagues published “First Birth from a Deceased Donor Uterus in the United States: From Severe Graft Rejection to Successful Cesarean Delivery,” hereafter “First Birth from a Deceased Donor,” in the American Journal of Obstetrics and Gynecology. In the article, Flyckt and colleagues explain that they performed one of the first uterus transplantations with a uterus from a deceased donor in the United States and detail how they did so successfully. All deceased donors in the study were considered brain-dead, not cardiac-dead. Uterus transplantation from a deceased donor is a surgical procedure in which a researcher transplants a healthy uterus from a brain-dead, deceased donor into a recipient with a diseased or absent uterus. Prior to 2020, researchers performed several uterus transplantations with live donors that resulted in live births, but there was only one recorded live birth from a deceased uterus donor. Flyckt and colleagues provide summary data about uterus transplantations from deceased donors and compare the efficacy of transplantations from live donors to those from deceased donors. “First Birth from a Deceased Donor” advances the techniques that can make uterus transplants from deceased donors successful, which allows people with uterine disorders the opportunity to become pregnant and have children.