Shankar Mridula, Gülmezoglu A Metin, Vogel Joshua P, Goudar Shivaprasad S, McDougall Annie, Somannavar Manjunath S, Rushwan Sara, Pujar Yeshita V, Charantimath Umesh, Ammerdorffer Anne, Bohren Meghan A
Gender and Women's Health Unit, Nossal Institute for Global Health, School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia.
Concept Foundation, Geneva, Switzerland/Bangkok, Thailand.
Commun Med (Lond). 2024 Oct 23;4(1):211. doi: 10.1038/s43856-024-00629-1.
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.
孕妇和性别多元化的孕妇在临床研究中的系统性代表性不足，使她们无法公平地从生物医学进步中受益。由此导致的药理安全性和有效性数据的缺乏，导致药物停用、剂量未达最佳水平以及对重新利用疗法的依赖。我们确定了公平纳入的四个障碍。第一，研究把关人持保护主义态度，将怀孕视为脆弱状态，这抑制了投资和研究。第二，排除忽视了影响药物吸收以及对孕妇身体影响的人类特定生物学差异。第三，低收入和中等收入国家的孕妇群体尽管承受着过高的孕产妇死亡负担，但由于性别和地理位置而面临双重不利处境。第四，孕妇群体的观点和经历在临床干预设计中未得到重视。我们提出五项行动以优化公平纳入：建立互惠伙伴关系、优先开展多学科研究、提高对药物创新需求的认识、进行监管分析以及促进负责任的纳入而非推定排除。
