Researchers at Fox Chase have found evidence that some clinical trials exclude gay and lesbian individuals from participating based on their sexual orientation.
All clinical trials are conducted under guidelines developed by the investigators stating who may participate. Typical criteria include factors such as age, gender, previous treatment history, type and stage of disease, and other medically relevant factors. However, the researchers found that some trials exclude individuals based on sexual orientation.
In reviewing a clinical trial database for criteria that required participants to be in heterosexual relationships, biostatistician Brian Egleston, biologist Roland Dunbrack, and medical oncologist Michael Hall found that the exclusion of lesbians and gay men from clinical trials is not uncommon in the United States, particularly in studies related to sexual function or couples counseling.
“Most gay and lesbian patients are probably unaware that their sexual orientation is being used as a screening factor for clinical trial participation,” Egleston notes. “This is a potentially significant issue, both for patients and the medical research community.”
The researchers searched ClinicalTrials.gov, a website that provides information on more than 80,000 trials sponsored by the National Institutes of Health, other governmental agencies, and private industry.
The searches, which included only trials with sites in the United States, showed that 15 percent of identified studies using the terms “erectile dysfunction,” “couples,” and “hypoactive” (related to hypoactive sexual disorder) included language exclusionary of gays and lesbians. In addition, industry-sponsored trials, multi-region trials, and Phase III trials were more likely to exclude lesbians and gay men.
The exclusionary language was not detected in studies unrelated to sexual function.
The findings were published in a research letter in the March 18 issue of The New England Journal of Medicine.
Following publication of these findings, U.S. senators led by John Kerry requested that Secretary of Health and Human Services Kathleen Sebelius investigate the alleged exclusionary practices. Their letter to Sebelius and a press release issued by Kerry can be found at fccc.edu/topics/excluded.