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

点击翻译按钮获取中文摘要

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.