Clinical trials to address the COVID-19 public health emergency have broadly excluded pregnant people from participation, illustrating a long-standing trend of clinical trial exclusion that has led to a clear knowledge gap and unmet need in the treatment and prevention of medical conditions experienced during pregnancy and of pregnancy-related conditions. Drugs (includes products such as drugs, biologics, biosimilars and vaccines) approved for a certain medical condition in adults are also approved for use in pregnant adults with the same medical condition, unless contraindicated for use in pregnancy. However, there are limited pregnancy-specific data on risks and benefits of drugs in pregnant people, despite their approval for all adults. The United States Food and Drug Administration–approved medical products are used widely by pregnant people, 90% of whom take at least 1 medication during the course of their pregnancy despite there being sparse data from clinical trials on these products in pregnancy. This overall lack of clinical data precludes informed decision-making, causing clinicians and pregnant patients to have to decide whether to pursue treatment without an adequate understanding of potential effects. Although some United States Food and Drug Administration initiatives and other federal efforts have helped to promote the inclusion of pregnant people in clinical research, broader collaboration and reforms are needed to address challenges related to the design and conduct of trials that enroll pregnant people, and to forge a culture of widespread inclusion of pregnant people in clinical research. This article summarizes the scientific, ethical, and legal considerations governing research conducted during pregnancy, as discussed during a recent subject matter expert convening held by the Duke-Margolis Center for Health Policy and the United States Food and Drug Administration on this topic. This article also recommends strategies for overcoming impediments to inclusion and trial conduct.

应对 COVID-19 突发公共卫生事件的临床试验广泛将孕妇排除在外，这表明临床试验排除的长期趋势导致在治疗和预防期间经历的医疗状况方面存在明显的知识差距和未满足的需求怀孕和与怀孕有关的情况。批准用于成人某种医疗状况的药物（包括药物、生物制剂、生物仿制药和疫苗等产品）也被批准用于具有相同医疗状况的孕妇，除非在怀孕期间禁忌使用。然而，尽管所有成年人都批准了这些药物，但关于孕妇服用药物的风险和益处的特定妊娠数据有限。美国食品和药物管理局批准的医疗产品被孕妇广泛使用，90% 的人在怀孕期间至少服用了一种药物，尽管这些产品在怀孕期间的临床试验数据很少。临床数据的总体缺乏阻碍了做出明智的决策，导致临床医生和孕妇不得不在没有充分了解潜在影响的情况下决定是否继续治疗。尽管美国食品和药物管理局的一些举措和其他联邦努力有助于促进将孕妇纳入临床研究，但仍需要更广泛的合作和改革，以应对与招募孕妇的试验的设计和实施相关的挑战，并营造一种将孕妇广泛纳入临床研究的文化。这篇文章总结了科学的、伦理的、正如杜克-马戈利斯卫生政策中心和美国食品和药物管理局最近就此主题召开的主题专家会议上讨论的那样，管理怀孕期间进行的研究的法律考虑因素。本文还推荐了克服纳入和审判行为障碍的策略。