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

IF 2.9 2区 社会学 Q1 HISTORY & PHILOSOPHY OF SCIENCE
Jason V D'Amours, Miranda R Waggoner
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引用次数: 0

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.

排除性数据,包容性申诉:艾滋病毒预防临床试验中的性别与公平。
尽管社会和监管机构期望新药的当代临床试验将包括不同的研究参与者,但在临床研究中实现适当的代表性仍然是脆弱的。目前令人担忧的是,专家和监管机构在面对人口统计数据有限的临床研究时,如何做出药物批准的决定。Descovy是一种hiv预防药物,仅在顺性男性和与男性发生性关系的跨性别女性中进行了研究,我们借鉴了关于Descovy的监管讨论,分析了在临床试验设计中包括或排除某些人群的意义和影响。在对临床试验中的认识论框架如何影响知识生产和社会正义的科学和技术研究进行扩展的基础上,我们展示了包容和公平的不同概念(具体而言,数据公平与获取公平)如何在药物批准的审议中产生紧张关系。我们认为,在Descovy案例中出现的关于性别和包容性/排他性研究实践的话语冲突,指出了公平的一个未被充分认识的特征——时间性——在检查21世纪临床和监管领域的知识生产时,应该注意到这一点。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Social Studies of Science
Social Studies of Science 管理科学-科学史与科学哲学
CiteScore
5.70
自引率
6.70%
发文量
45
审稿时长
>12 weeks
期刊介绍: Social Studies of Science is an international peer reviewed journal that encourages submissions of original research on science, technology and medicine. The journal is multidisciplinary, publishing work from a range of fields including: political science, sociology, economics, history, philosophy, psychology social anthropology, legal and educational disciplines. This journal is a member of the Committee on Publication Ethics (COPE)
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