DEVELOPING A FRAMEWORK TO ADDRESS LEGAL, ETHICAL, REGULATORY, AND POLICY ISSUES FOR RESEARCH SPECIFIC TO PREGNANT AND LACTATING PERSONS

美国每年有超过600万女性怀孕。在这些妇女中，超过90%的人在怀孕和哺乳期间至少服用一种药物。然而，孕妇和哺乳期妇女往往被排除在最终可能帮助这些人群的临床研究之外。《21世纪世纪治愈法》设立了专门针对孕妇和哺乳期妇女的研究工作队，就孕妇和哺乳期妇女安全有效疗法的知识和研究差距向卫生与公众服务部部长提出建议。PRGLAC的任务是确定这些差距，并向秘书报告其调查结果。该工作队负责向卫生与公众服务部（HHS）提供咨询和指导，以确定和解决孕妇和哺乳期妇女安全有效疗法的知识和研究方面的差距，包括开发此类疗法以及合作和协调此类活动。除了向部长提供咨询意见外，工作队还负责编写并向部长和国会提交一份包括五个要素的报告。 第一章 一项计划，以确定和解决在孕妇和哺乳期妇女安全有效疗法方面的知识和研究差距，包括开发此类疗法。 （二） 临床研究中纳入孕妇和哺乳期妇女的伦理问题。 第三章 与医疗保健提供者和公众就孕妇和哺乳期妇女相关信息制定有效的沟通策略。 四、 识别联邦活动，包括 a. 关于怀孕和哺乳的研究状况; B. 就孕妇和哺乳期妇女相关研究的协调与合作提出建议; C. 向提供者和公众传播与孕妇和哺乳期妇女有关的研究结果和信息; D. 现有的联邦努力和计划，以提高对孕妇、哺乳期妇女健康影响以及相关分娩和儿科结局的科学认识，包括药代动力学、药效学和毒性 第五章） 建议改善孕妇和哺乳期妇女安全有效的治疗方法的发展。

Over six million women are pregnant in the United States each year. Of these women, more than 90 percent take at least one medication during pregnancy and lactation. However, pregnant women and lactating women are often excluded from clinical research that could ultimately help these populations. The 21st Century Cures Act established the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) to advise the Secretary of Health and Human Services (HHS) regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. PRGLAC was tasked with identifying these gaps and reporting its findings back to the Secretary. The Task Force was charged with providing advice and guidance to the Secretary of Health and Human Services (HHS) on activities related to identifying and addressing gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women, including the development of such therapies and the collaboration on and coordination of such activities. In addition to advising the Secretary, the Task Force was charged with preparing and submitting to the Secretary and Congress a report that includes five elements. 1) A plan to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies. 2) Ethical issues surrounding the inclusion of pregnant women and lactating women in clinical research. 3) Effective communication strategies with health care providers and the public on information relevant to pregnant women and lactating women. 4) Identification of Federal activities, including a. the state of research on pregnancy and lactation; b. recommendations for the coordination of, and collaboration on research related to pregnant women and lactating women; c. dissemination of research findings and information relevant to pregnant women and lactating women to providers and the public; d. existing Federal efforts and programs to improve the scientific understanding of the health impacts on pregnant women, lactating women, and related birth and pediatric outcomes, including with respect to pharmacokinetics, pharmacodynamics, and toxicities 5) Recommendations to improve the development of safe and effective therapies for pregnant women and lactating women.