Exclusionary data,inclusionary appeals: Gender and equity in an HIV-prevention clinical trial

Abstract

Despite the social and regulatory expectation that contemporary clinical trials for new pharmaceutical drugs will include a diverse set of research participants, achieving appropriate representation in clinical research remains tenuous. Of ongoing concern is how experts and regulators navigate decisions about drug approvals when presented with clinical studies that have limited demographic data. Drawing on regulatory discussions about Descovy, an HIV-prevention drug that was studied only in cisgender men and transgender women who have sex with men, we analyze a contentious debate over the meaning and impact of including and excluding certain populations from clinical trial design. Extending prior work in science and technology studies on how epistemological frameworks in clinical trials matter for concerns about the production of knowledge and social justice, we show how different conceptualizations of inclusion and equity (specifically, equity in data versus equity in access) come into tension in deliberations over pharmaceutical drug approvals. We argue that the discursive conflict over gender and inclusionary/exclusionary research practices that emerged in the case of Descovy points to an underappreciated feature of equity—temporality—that should be attended to when examining knowledge production in 21st-century clinical and regulatory landscapes.

Keywords

clinical trials HIV PrEP inclusion biomedical research

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