Scientific, ethical, and legal considerations for the inclusion of pregnant people in clinical trials.
Scientific, ethical, and legal considerations for the inclusion of pregnant people in clinical trials.
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DOI：
10.1016/j.ajog.2022.07.037
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发表时间：
2022-12
影响因子：
9.8
通讯作者：
中科院分区：
文献类型：
--
作者：
应对COVID-19突发公共卫生事件的临床试验广泛地将孕妇排除在参与范围之外，这说明了临床试验排除的长期趋势，导致在治疗和预防妊娠期间出现的医疗状况和妊娠相关状况方面存在明显的知识差距和未满足的需求。批准用于成人某种疾病的药物（包括药物、生物制剂、生物仿制药和疫苗等产品）也批准用于患有相同疾病的妊娠成人，除非禁忌在妊娠期使用。然而，尽管药物已批准适用于所有成年人，但有关药物对孕妇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，其中90%的孕妇在怀孕期间服用至少一种药物，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妨碍了知情决策，导致临床医生和怀孕患者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。虽然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，但需要更广泛的合作和改革，以应对与设计和开展招募孕妇的试验有关的挑战，并形成将孕妇广泛纳入临床研究的文化。本文总结了科学，伦理和法律的考虑，在怀孕期间进行的研究，讨论在最近召开的主题专家会议由杜克-马戈利斯中心卫生政策和美国食品和药物管理局就这个问题。本文还提出了克服纳入和试验进行障碍的策略。
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.
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影响因子：
9.8
作者：
Mitchell AA;Gilboa SM;Werler MM;Kelley KE;Louik C;Hernández-Díaz S;National Birth Defects Prevention Study
通讯作者：
National Birth Defects Prevention Study
影响因子：
3.4
作者：
Henry, Leslie Meltzer;Larkin, Megan E.;Pike, Elizabeth R.
通讯作者：
Pike, Elizabeth R.
影响因子：
9.8
作者：
Modi N;Ayres-de-Campos D;Bancalari E;Benders M;Briana D;Di Renzo GC;Fonseca EB;Hod M;Poon L;Cortes MS;Simeoni U;Tscherning C;Vento M;Visser GHA;Voto L
通讯作者：
Voto L
DOI：
10.2979/fab.2008.1.2.5
发表时间：
2008-01-01
影响因子：
0.7
作者：
Lyerly, Anne Drapkin;Little, Margaret Olivia;Faden, Ruth
通讯作者：
Faden, Ruth