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Inclusion of pregnant and lactating persons in clinical trials : proceedings of a workshop /
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| 자료유형 | E-Book |
|---|---|
| 개인저자 | Wizemann, Theresa M., rapporteur. March, Andrew, (Associate program officer), rapporteur. Shore, Carolyn, rapporteur. |
| 단체저자명 | National Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Drug Discovery, Development, and Translation,issuing body. |
| 서명/저자사항 | Inclusion of pregnant and lactating persons in clinical trials :proceedings of a workshop /Theresa Wizemann, Andrew March, and Carolyn Shore, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division. |
| 형태사항 | 1 online resource (1 PDF file (xviii, 127 pages)) |
| 소장본 주기 | WorldCat record variable field(s) change: 082 |
| ISBN | 9780309696371 0309696372 9780309696388 0309696380 9780309696401 0309696402 |
| 서지주기 | Includes bibliographical references. |
| 요약 | Approximately 4 million pregnant people in the United States give birth annually, and 70 percent of these individuals take at least one prescription medication during their pregnancy. Yet, due to a number of historical, ethical, legal, scientific, and societal issues, pregnant and lactating persons are often excluded from clinical trials. As a result, pregnant and lactating persons are often taking drugs based on limited information about the benefits and risks to themselves and their developing or newborn baby. The National Academies Forum on Drug Discovery, Development, and Translation convened a workshop in June 2022 for stakeholders to examine the current state of evidence generation for drug products used by pregnant and lactating persons and discuss barriers and opportunities for including these populations in clinical trials. This publication summarizes the presentations and discussion of the workshop. |
| 기금정보주기 | This activity was supported by contracts between the National Academy of Sciences and Amgen Inc.; Association of American Medical Colleges; AstraZeneca; Biogen; Burroughs Wellcome Fund (Contract No. 1022279); Critical Path Institute; Eli Lilly & Co. (Contract No. 4900709231); FasterCures, Milken Institute; Foundation for the National Institutes of Health; Friends of Cancer Research; Johnson & Johnson; Medable, Inc.; Merck & Co., Inc. (Contract No. APA-21-151620); National Institutes of Health (Contract No. HHSN263201800029I, Task Order No. HHSN26300007): National Cancer Institute, National Center for Advancing Translational Sciences, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Office of Science Policy; New England Journal of Medicine; Sanofi (Contract No. 70602577); Takeda Pharmaceuticals; and the U.S. Food and Drug Administration (Grant No. 1R13FD007302-01). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. |
| 일반주제명 | Clinical trials. Pregnant women. Lactation. Drugs -- Testing. Clinical medicine -- Research. Discrimination in medical care. Women -- Health. Infants -- Effect of drugs on. Risk assessment. Clinical Trials as Topic Pregnant Women Lactation -- drug effects Pregnancy -- drug effects Patient Selection Therapeutic Human Experimentation Risk Assessment Lactation Research Design E?tudes cliniques. Femmes enceintes. Lactation. Me?dicaments -- Essais cliniques. Me?decine clinique -- Recherche. Discrimination dans les soins me?dicaux. Femmes -- Sante?. Se?lection de patients. E?valuation du risque. risk assessment. Clinical medicine -- Research Clinical trials Discrimination in medical care Drugs -- Testing Infants -- Effect of drugs on Lactation Pregnant women Women -- Health |
| 주제명(지명) | United States |
| 언어 | 영어 |
| 기타형태 저록 | Print version:National Academies of Sciences, Engineering, and Medicine.Inclusion of Pregnant and Lactating Persons in Clinical Trials.Washington, D.C. : National Academies Press, 20239780309696388 Print version:03096963729780309696371 |
| 대출바로가기 | https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=3589040 |
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