Treatment Action Group, New York, New York.
Community Research Advisors Group, New York, New York.
Clin Infect Dis. 2017 Oct 15;65(8):1383-1387. doi: 10.1093/cid/cix533.
Affecting both mother and the existing pregnancy, tuberculosis (TB) increases the likelihood of poor birth outcomes. Despite substantial clinical need for TB prevention and treatment, pregnant women remain neglected by research initiatives. As members of 3 community advisory boards that provide input into TB drug trials, we offer a community perspective on the inclusion of pregnant women in TB drug research and discuss (1) our perspective on the risk/benefit tradeoff of including pregnant women in research to address different forms of TB; (2) recent examples of progress in this area; (3) lessons learned from the human immunodeficiency virus research field, where pregnant women have enjoyed better-although imperfect-representation in research; and (4) recommendations for different stakeholders, including researchers, regulatory authorities, ethics committees, and policymakers.
既影响母亲又影响现有妊娠的结核病（TB）增加了不良生育结局的可能性。尽管在结核病预防和治疗方面有大量临床需求，但研究计划仍忽略了孕妇。作为为结核病药物试验提供投入的 3 个社区咨询委员会的成员，我们从社区的角度出发，探讨了将孕妇纳入结核病药物研究的问题，并讨论了（1）我们对将孕妇纳入研究以解决不同形式结核病的风险/获益权衡的看法；（2）这一领域的最新进展实例；（3）从艾滋病毒研究领域吸取的经验教训，在该领域，孕妇在研究中的代表性有所改善（尽管仍不完善）；以及（4）针对包括研究人员、监管机构、伦理委员会和政策制定者在内的不同利益攸关方的建议。
