Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people

IF 5.4 Q1 MEDICINE, RESEARCH & EXPERIMENTAL Communications medicine Pub Date : 2024-10-23 DOI:10.1038/s43856-024-00629-1
Mridula Shankar, A. Metin Gülmezoglu, Joshua P. Vogel, Shivaprasad S. Goudar, Annie McDougall, Manjunath S. Somannavar, Sara Rushwan, Yeshita V. Pujar, Umesh Charantimath, Anne Ammerdorffer, Meghan A. Bohren
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Abstract

Systematic under-representation of pregnant women and gender diverse pregnant people in clinical research has prevented them from benefitting fairly from biomedical advances. The resulting lack of pharmacological safety and efficacy data leads to medicine discontinuation, sub-optimal dosing, and reliance on repurposed therapies. We identify four roadblocks to fair inclusion. First, investment and research are inhibited by protectionist attitudes among research gatekeepers who view pregnancy as a vulnerable state. Second, exclusion ignores human-specific biological variations affecting medication absorption and impacts on the pregnant body. Third, pregnant populations in low-and middle-income countries face a double disadvantage due to gender and location, despite bearing a disproportionate maternal mortality burden. Fourth, perspectives and experiences of pregnant populations are undervalued in clinical intervention design. We propose five actions to optimize fair inclusion: fostering reciprocal partnerships, prioritizing multi-disciplinary research, awareness-raising of the need for pharmaceutical innovation, conducting regulatory analyses, and promoting responsible inclusion over presumptive exclusion. Shankar et al. discuss how to better undertake research and assure health interests of pregnant women and gender diverse pregnant people. Their recommendations include growing research and regulatory partnerships and innovation, plus promoting responsible inclusion in place of presumptive exclusion.

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要消除生物医学研究中的性别偏见,就必须公平地接纳孕妇和不同性别的人。
孕妇和不同性别的孕妇在临床研究中的代表性一直不足,这使她们无法公平地受益于生物医学的进步。由于缺乏药理学安全性和有效性数据,导致停药、用药剂量不达标,以及依赖于重新设计的疗法。我们指出了公平纳入的四个障碍。首先,研究把关人的保护主义态度阻碍了投资和研究,他们认为怀孕是一种脆弱的状态。其次,排除法忽视了影响药物吸收和对孕妇身体影响的人体特异性生物变异。第三,中低收入国家的孕妇由于性别和地理位置的原因面临双重不利条件,尽管他们承受着过重的孕产妇死亡负担。第四,在临床干预设计中,孕妇的观点和经验被低估。我们建议采取五项行动来优化公平包容:促进互惠伙伴关系、优先考虑多学科研究、提高对药物创新需求的认识、开展监管分析以及促进负责任的包容而非假定性排斥。
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