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

制定一个框架来解决针对孕妇和哺乳期人士的研究的法律、道德、监管和政策问题

• 批准号: 10708237
• 负责人: ROBERT DAY
• 金额: $ 149.72万
• 依托单位: NATIONAL ACADEMY OF SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-22 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10708237
• 关键词: Address; Advisory Committees; Back; Biotechnology; Birth; Charge; Childhood; Clinical Research; Clinical Trials; Collaborations; Communication; Congresses; Consensus; Coordination and Collaboration; Data Analyses; Data Collection; Development; Diagnostic Equipment; Discipline; Drug Delivery Systems; Drug Kinetics; Elements; Engineering; Ethical Issues; Ethics; Funding; Government; Health; Health Personnel; Health Policy; Human; Individual; Industry; Informed Consent; Institution; Institutional Review Boards; Insurance; Knowledge; Lactation; Laws; Lawyers; Legal; Legal Rights; Legal patent; Manufacturer Name; Maternal-fetal medicine; Medical; Medical Device; Medicine; Negligence; Outcome; Participant; Persons; Pharmaceutical Preparations; Pharmacodynamics; Pharmacologic Substance; Policies; Population; Pregnancy; Pregnant Women; Privatization; Procedures; Provider; Recommendation; Regulation; Reporting; Research; Research Personnel; Risk; Services; Specialist; Therapeutic; Tort; Toxic effect; United States; United States National Academy of Sciences; Vaccines; Woman; Work; effective therapy; experience; improved; novel therapeutics; novel vaccines; off-patent; pregnant; programs

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.

在美国，每年有600多万妇女怀孕。在这些妇女中，超过90%的人在怀孕和哺乳期至少服用一种药物。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世纪治疗法》设立了专门针对孕妇和哺乳期妇女的研究特别工作组(PRGLAC)，就孕妇和哺乳期妇女安全有效治疗的知识和研究方面的差距向卫生与公众服务部部长(HHS)提出建议。PRGLAC的任务是找出这些差距，并将调查结果报告给秘书。工作队负责就以下活动向卫生与公众服务部部长提供咨询和指导：查明和解决孕妇和哺乳期妇女安全有效疗法方面的知识和研究方面的差距，包括开发这种疗法以及就这种活动进行协作和协调。除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项内容的报告。 1)确定和解决关于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，包括开发这种疗法的计划。 2)将孕妇和哺乳期妇女纳入临床研究的伦理问题。 3)与保健提供者和公众就与孕妇和哺乳期妇女有关的信息采取有效的沟通策略。 4)确定联邦活动，包括 A.关于怀孕和哺乳的研究状况； B.就与孕妇和哺乳期妇女有关的研究协调和协作提出建议； 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、哺乳期妇女的健康影响以及相关的分娩和儿科结果的科学理解，包括关于药代动力学、药效学和毒性的 5)建议改进为孕妇和哺乳期妇女开发安全有效的治疗方法。