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| Clinical Trials Rarely Mention Transsexuals; Often Exclude Gays and Lesbians |
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| SciMed - Horizons | |||
| TS-Si News Service | |||
| Friday, 19 March 2010 15:00 | |||
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Philadelphia, PA, USA. Clinical trials rarely mention transsexuals, while often excluding gays and lesbians. All clinical trials have guidelines that clearly state who can and cannot participate, but these guidelines are typically based on age, gender, previous treatment history, the type and stage of a disease or condition, and other medically relevant factors. Exploratory searches of ClinicalTrials.gov — detailed information on over 87,000 clinical trials sponsored by the National Institutes of Health (NIH), other governmental agencies, and private industry — found explicit inclusion and exclusion criteria requiring participants to be in heterosexual relationships. The research reported on here gathered evidence indicating that some trials explicitly exclude individuals based on their sexual orientation. The exclusion of lesbians and gay men from clinical trials in the United States is not uncommon, particularly in studies with sexual function as an endpoint. The findings are published in a research letter that appears in the New England Journal of Medicine (NEJM). A separate and detailed search by TS-Si.org returned no explicit exclusion of transsexuals, but a likely presumption that such individuals are categorized in terms of their birth sex without regard to the transformative effects of hormonal reconstitution and surgical correction. The research analysis by TS-Si.org shows only slight attention to the medical needs of transsexuals. A search returned only seven clinical trials (two completed) that even mention the word "transsexual", while incorporating transsexual medical concerns into a broader consideration of the "LGBT" population. Two of the studies are concerned with smoking and one on HIV, leaving four others with some direct relationship to transsexualism out of 87,000+ clinical trials in the government database. Three of the seven trials are conducted in the United States. See this link for a summary. Understanding Brian Egleston, Ph.D., is an assistant research professor of biostatistics and Dunbrack and his colleagues focused their research on Gay and Lesbian exclusion from the trials, but their approach has implications for transsexual inclusion and exclusion. A contemporary psychosocial bias informs much of contemporary medical eduction and assigns the transsexual birth condition to a matter of sexual behavior. "Most gay and lesbian patients are probably unaware that their sexual orientation is being used as a screening factor for clinical trial participation," notes Egleston. "This is a potentially significant issue, both for patients and the medical research community." The searches, which included only trials with sites in the United States, showed that 15 percent of the identified studies using the terms "erectile dysfunction," "couples," and "hypoactive" had exclusionary language. In addition, the results indicated that industry sponsored trials, multi-region trials, and Phase III trials were more likely to exclude lesbians and gay men among these studies. As discussed earlier, transsexual medical concerns are barely mentioned at all. "The trials that exclude gay and lesbian patients tend to be larger efficacy clinical trials. Further, by requiring patients to be in heterosexual relationships, many studies are also excluding unmarried or unpartnered patients regardless of sexual orientation," says Dunbrack. To ensure that there was not a general pattern of exclusionary language missed, the researchers also looked at 1,019 studies identified by the search term "asthma." This search did not find any studies that excluded lesbians and gay men. FundingThis research was supported in part by a grant from the National Institutes of Health (NIH) and an appropriation from the Commonwealth of Pennsylvania.
CitationClinical Trials That Explicitly Exclude Gay and Lesbian Patients. Brian L. Egleston, Roland L. Dunbrack, Jr., and Michael J. Hall. NEJM 2010; 362(11): 1054-1055.
Correspondence We recently encountered proposed studies that explicitly excluded persons in same-sex relationships. We therefore decided to gather data on clinical trials to see whether this phenomenon is common. We performed exploratory searches of the ClinicalTrials.gov database to identify categories of studies from which lesbians and gay men were likely to be explicitly excluded. The ClinicalTrials.gov database contains detailed information on more than 80,000 clinical trials sponsored by the National Institutes of Health, other governmental agencies, and private industry. We sought explicit inclusion and exclusion criteria that would restrict trials to heterosexual patients, such as study requirements that participants be in heterosexual relationships. We included only studies with sites in the United States. All searches were conducted from November 4 through November 11, 2009. We found that when we performed searches using the terms "couples," "erectile dysfunction," and "hypoactive" (related to hypoactive sexual disorder), we identified 243 studies, of which 37 (15%) had explicit exclusionary language (Table 1). In these 243 studies, the results of Fisher's exact tests indicated that industry-sponsored trials, multiregion trials (according to census definitions), and phase 3 trials were the most likely to exclude lesbians and gay men (P<0.05). Other variables, such as the year the study opened, whether the study is open to those over 65 years of age, and whether the study accepts healthy volunteers, were not associated with exclusionary criteria. To ensure that we did not miss a general pattern of exclusionary language, we also examined eligibility criteria in 1019 studies that we identified by using the search term "asthma." Exploratory searches indicated that such studies did not have high rates of exclusionary language, and indeed, no asthma trials were found to exclude lesbians and gay men. However, we incidentally found a clinical trial of attention deficit–hyperactivity disorder that required that participants be "in a reciprocal relationship with a person of the opposite sex." Our results indicate that exclusion of lesbians and gay men from clinical trials in the United States is not uncommon, particularly in studies with sexual function as an end point. It is likely that most gay and lesbian patients are unaware that their sexual orientation is being used as a screening factor for participation in clinical trials. Researchers should be held to careful scientific reasoning when they develop exclusion criteria that are based on sexual orientation.
 The TS-Si News Service is a collaborative effort by TS-Si.org editors, contributors, and corresponding institutions. Sources can include the cited individuals and organizations, as well as TS-Si.org staff contributions. Articles and news reports do not necessarily convey official positions of TS-Si, its partners, or affiliates. We welcome your comments. Use the form below to leave a public comment or send private correspondence via the TS-Si Contact Page. We will not divulge any personal details or place you on a mailing list without your permission.TS-Si is dedicated to the acceptance, medical treatment, and legal protection of individuals correcting the misalignment of their brains and their anatomical sex, while supporting their transition into society as hormonally reconstituted and surgically corrected citizens.
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