Improving Representation In Clinical Trials And Research

Author : National Academies of Sciences Engineering and Medicine
Publisher :
ISBN 13 : 9780309278201
Total Pages : pages
Book Rating : 4.01/5 ( download)

DOWNLOAD NOW!

Download or read book Improving Representation in Clinical Trials and Research written by National Academies of Sciences Engineering and Medicine and published by . This book was released on 2023-02-17 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States has long made substantial investments in clinical research with the goal of improving the health and well-being of our nation. There is no doubt that these investments have contributed significantly to treating and preventing disease and extending human life. Nevertheless, clinical research faces a critical shortcoming. Currently, large swaths of the U.S. population, and those that often face the greatest health challenges, are less able to benefit from these discoveries because they are not adequately represented in clinical research studies. While progress has been made with representation of white women in clinical trials and clinical research, there has been little progress in the last three decades to increase participation of racial and ethnic minority population groups. This underrepresentation is compounding health disparities, with serious consequences for underrepresented groups and for the nation. At the request of Congress, Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups identifies policies, procedures, programs, or projects aimed at increasing the inclusion of these groups in clinical research and the specific strategies used by those conducting clinical trials and clinical and translational research to improve diversity and inclusion. This report models the potential economic benefits of full inclusion of men, women, and racial and ethnic groups in clinical research and highlights new programs and interventions in medical centers and other clinical settings designed to increase participation.

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309443571
Total Pages : 85 pages
Book Rating : 4.79/5 ( download)

DOWNLOAD NOW!

Download or read book Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-09-24 with total page 85 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309443601
Total Pages : 85 pages
Book Rating : 4.09/5 ( download)

DOWNLOAD NOW!

Download or read book Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-08-24 with total page 85 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309494885
Total Pages : 127 pages
Book Rating : 4.85/5 ( download)

DOWNLOAD NOW!

Download or read book Virtual Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-11-16 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 304 pages
Book Rating : 4.23/5 ( download)

DOWNLOAD NOW!

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030904992X
Total Pages : 286 pages
Book Rating : 4.24/5 ( download)

DOWNLOAD NOW!

Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309452961
Total Pages : 583 pages
Book Rating : 4.60/5 ( download)

DOWNLOAD NOW!

Download or read book Communities in Action written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-04-27 with total page 583 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the United States, some populations suffer from far greater disparities in health than others. Those disparities are caused not only by fundamental differences in health status across segments of the population, but also because of inequities in factors that impact health status, so-called determinants of health. Only part of an individual's health status depends on his or her behavior and choice; community-wide problems like poverty, unemployment, poor education, inadequate housing, poor public transportation, interpersonal violence, and decaying neighborhoods also contribute to health inequities, as well as the historic and ongoing interplay of structures, policies, and norms that shape lives. When these factors are not optimal in a community, it does not mean they are intractable: such inequities can be mitigated by social policies that can shape health in powerful ways. Communities in Action: Pathways to Health Equity seeks to delineate the causes of and the solutions to health inequities in the United States. This report focuses on what communities can do to promote health equity, what actions are needed by the many and varied stakeholders that are part of communities or support them, as well as the root causes and structural barriers that need to be overcome.

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498244
Total Pages : 235 pages
Book Rating : 4.41/5 ( download)

DOWNLOAD NOW!

Download or read book Promising Practices for Addressing the Underrepresentation of Women in Science, Engineering, and Medicine written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-19 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Careers in science, engineering, and medicine offer opportunities to advance knowledge, contribute to the well-being of communities, and support the security, prosperity, and health of the United States. But many women do not pursue or persist in these careers, or advance to leadership positions - not because they lack the talent or aspirations, but because they face barriers, including: implicit and explicit bias; sexual harassment; unequal access to funding and resources; pay inequity; higher teaching and advising loads; and fewer speaking invitations, among others. There are consequences from this underrepresentation of women for the nation as well: a labor shortage in many science, engineering, and medical professions that cannot be filled unless institutions and organizations recruit from a broad and diverse talent pool; lost opportunities for innovation and economic gain; and lost talent as a result of discrimination, unconscious bias, and sexual harassment. Promising Practices for Addressing the Underrepresentation of Women in Science, Engineering, and Medicine reviews and synthesizes existing research on policies, practices, programs, and other interventions for improving the recruitment, retention, and sustained advancement into leadership roles of women in these disciplines. This report makes actionable recommendations to leverage change and drive swift, coordinated improvements to the systems of education, research, and employment in order to improve both the representation and leadership of women.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309172802
Total Pages : 88 pages
Book Rating : 4.06/5 ( download)

DOWNLOAD NOW!

Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030908265X
Total Pages : 781 pages
Book Rating : 4.55/5 ( download)

DOWNLOAD NOW!

Download or read book Unequal Treatment written by Institute of Medicine and published by National Academies Press. This book was released on 2009-02-06 with total page 781 pages. Available in PDF, EPUB and Kindle. Book excerpt: Racial and ethnic disparities in health care are known to reflect access to care and other issues that arise from differing socioeconomic conditions. There is, however, increasing evidence that even after such differences are accounted for, race and ethnicity remain significant predictors of the quality of health care received. In Unequal Treatment, a panel of experts documents this evidence and explores how persons of color experience the health care environment. The book examines how disparities in treatment may arise in health care systems and looks at aspects of the clinical encounter that may contribute to such disparities. Patients' and providers' attitudes, expectations, and behavior are analyzed. How to intervene? Unequal Treatment offers recommendations for improvements in medical care financing, allocation of care, availability of language translation, community-based care, and other arenas. The committee highlights the potential of cross-cultural education to improve provider-patient communication and offers a detailed look at how to integrate cross-cultural learning within the health professions. The book concludes with recommendations for data collection and research initiatives. Unequal Treatment will be vitally important to health care policymakers, administrators, providers, educators, and students as well as advocates for people of color.