Inclusion of Women in Clinical Trials PDF Download

Author:
Publisher: National Academies
ISBN:
Category : Medical policy
Languages : en
Pages : 20

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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904992X
Category : Medical
Languages : en
Pages : 286

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Book Description
In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

Author: United States. Food and Drug Administration. Bureau of Drugs
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20

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Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309443571
Category : Medical
Languages : en
Pages : 85

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Book Description
Even as the U.S. population becomes steadily more diverse, minorities and women remain underrepresented in clinical trials to develop new drugs and medical devices. Although progress in increasing minority participation in clinical trials has occurred, participation rates do not fully represent the overall population of minorities in the United States. This underrepresentation threatens the health of both these populations and the general population, since greater minority representation could reveal factors that affect health in all populations. Federal legislation has sought to increase the representation of minorities and women in clinical trials, but legislation by itself has not been sufficient to overcome the many barriers to greater participation. Only much broader changes will bring about the meaningful participation of all population groups in the clinical research needed to improve health. To examine the barriers to participation in clinical trials and ways of overcoming those barriers, the National Academies of Sciences, Engineering, and Medicine held a workshop in April 2015. This publication summarizes the presentations and discussions from the workshop.

Author:
Publisher:
ISBN:
Category : Women
Languages : en
Pages : 84

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Author: National Institutes of Health (U.S.). Office of Research on Women's Health
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages : 126

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Book Description

Author: Françoise Baylis
Publisher: Springer
ISBN: 3319265121
Category : Medical
Languages : en
Pages : 301

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This book discusses ‘how’ to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons ‘why’ the inclusion of pregnant women in clinical research is necessary – viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309163374
Category : Medical
Languages : en
Pages : 439

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Even though slightly over half of the U.S. population is female, medical research historically has neglected the health needs of women. However, over the past two decades, there have been major changes in government support of women's health research-in policies, regulations, and the organization of research efforts. To assess the impact of these changes, Congress directed the Department of Health and Human Services (HHS) to ask the IOM to examine what has been learned from that research and how well it has been put into practice as well as communicated to both providers and women. Women's Health Research finds that women's health research has contributed to significant progress over the past 20 years in lessening the burden of disease and reducing deaths from some conditions, while other conditions have seen only moderate change or even little or no change. Gaps remain, both in research areas and in the application of results to benefit women in general and across multiple population groups. Given the many and significant roles women play in our society, maintaining support for women's health research and enhancing its impact are not only in the interest of women, they are in the interest of us all.

Author: Steven Epstein
Publisher: ReadHowYouWant.com
ISBN: 1459606027
Category : Medical
Languages : en
Pages : 430

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Book Description
With Inclusion, Steven Epstein argues that strategies to achieve diversity in medical research mask deeper problems, ones that might require a different approach and different solutions. Formal concern with this issue, Epstein shows, is a fairly recent phenomenon. Until the mid-1980s, scientists often studied groups of white, middle-aged men - and assumed that conclusions drawn from studying them would apply to the rest of the population. But struggles involving advocacy groups, experts, and Congress led to reforms that forced researchers to diversify the population from which they drew for clinical research. While the prominence of these inclusive practices has offered hope to traditionally underserved groups, Epstein argues that it has drawn attention away from the tremendous inequalities in health that are rooted not in biology but in society. This edition is in two volumes. The second volume ISBN is 9781458732194.

Author: Irene Dankwa-Mullan
Publisher: John Wiley & Sons
ISBN: 1119374812
Category : Science
Languages : en
Pages : 548

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Book Description
Integrates the various disciplines of the science of health disparities in one comprehensive volume The Science of Health Disparities Research is an indispensable source of up-to-date information on clinical and translational health disparities science. Building upon the advances in health disparities research over the past decade, this authoritative volume informs policies and practices addressing the diseases, disorders, and gaps in health outcomes that are more prevalent in minority populations and socially disadvantaged communities. Contributions by recognized scholars and leaders in the field—featuring contemporary research, conceptual models, and a broad range of scientific perspectives—provide an interdisciplinary approach to reducing inequalities in population health, encouraging community engagement in the research process, and promoting social justice. In-depth chapters help readers better understand the specifics of minority health and health disparities while demonstrating the importance of advancing theory, refining measurement, improving investigative methods, and diversifying scientific research. In 26 chapters, the book examines topics including the etiology of health disparities research, the determinants of population health, research ethics, and research in African American, Asians, Latino, American Indian, and other vulnerable populations. Providing a unified framework on the principles and applications of the science of health disparities research, this important volume: Defines the field of health disparities science and suggests new directions in scholarship and research Explains basic definitions, principles, and concepts for identifying, understanding and addressing health disparities Provides guidance on both conducting health disparities research and translating the results Examines how social, historical and contemporary injustices may influence the health of racial and ethnic minorities Illustrates the increasing national and global importance of addressing health disparities Discusses population health training, capacity-building, and the transdisciplinary tools needed to advance health equity A significant contribution to the field, The Science of Health Disparities Research is an essential resource for students and basic and clinical researchers in genetics, population genetics, and public health, health care policymakers, and epidemiologists, medical students, and clinicians, particularly those working with minority, vulnerable, or underserved populations.