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Inclusion of pregnant and lactating persons in clinical trials : proceedings of a workshop /

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자료유형E-Book
개인저자Wizemann, Theresa M., rapporteur.
March, Andrew, (Associate program officer), rapporteur.
Shore, Carolyn, rapporteur.
단체저자명National Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Drug Discovery, Development, and Translation,issuing body.
서명/저자사항Inclusion 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.
형태사항1 online resource (1 PDF file (xviii, 127 pages))
소장본 주기WorldCat record variable field(s) change: 082
ISBN9780309696371
0309696372
9780309696388
0309696380
9780309696401
0309696402
서지주기Includes bibliographical references.
요약Approximately 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.
기금정보주기This 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.
일반주제명Clinical 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
언어영어
기타형태 저록Print 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
대출바로가기https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=3589040

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