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Clinical Trials in Vulnerable Populations by Milica Prostran Pdf
This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.
Clinical Trials in Vulnerable Populations by Milica Prostran Pdf
This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.
Vulnerable Populations in the United States by Leiyu Shi,Gregory D. Stevens Pdf
An in-depth look at disparities in health and health care, fully updated for 2021 Vulnerable Populations in the United States, 3rd Edition provides a general framework for studying vulnerable populations and summarizes major health and health care disparities by race/ethnicity, socioeconomic status, and health insurance coverage. This updated contains the latest statistics and figures, incorporates new information related to Healthy People 2020, analyzes the latest data and trends in health and health care disparities, and provides a detailed synthesis of recent and increasingly expansive programs and initiatives to remedy these disparities. In addition, the Third Edition offers new coverage of health care reform, the "deaths of despair" (suicide, opioids, etc.), and the global primary care initiative. Based on the authors' teaching and research at the Johns Hopkins Bloomberg School of Public Health and the Keck School of Medicine of the University of Southern California, this landmark text is an important resource for students, researchers, practitioners, and policymakers for learning about vulnerable populations. The book's Web site includes instructor's materials that may be downloaded. Gain a general understanding of health and health care disparities related to race/ethnicity, socioeconomic status, and health insurance coverage Access online resources including editable PowerPoint slides, video, and more Delve into the programs and initiatives designed to remedy inequalities in health and health care, including Healthy People 2020 updates Enjoy new coverage of health care reform, the "deaths of despair" (suicide, opioids, etc.), and the global primary care initiative End of chapter revision questions and other pedagogical features make this book a valuable learning tool for anyone studying at the advanced undergraduate or graduate levels. Additionally, it will prove useful in the field for medical professionals, social and community workers, and health educators in the public sphere.
Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Publisher : National Academies Press Page : 304 pages File Size : 41,9 Mb Release : 2015-04-20 Category : Medical ISBN : 9780309316323
Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf
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.
Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Publisher : National Academies Press Page : 222 pages File Size : 50,9 Mb Release : 2001-01-01 Category : Medical ISBN : 0309171148
Small Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Pdf
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Roundtable on the Promotion of Health Equity and the Elimination of Health Disparities
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Roundtable on the Promotion of Health Equity and the Elimination of Health Disparities Publisher : National Academies Press Page : 85 pages File Size : 46,8 Mb Release : 2016-09-24 Category : Medical ISBN : 9780309443579
Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Roundtable on the Promotion of Health Equity and the Elimination of Health Disparities Pdf
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.
Ethics Dumping by Doris Schroeder,Julie Cook,François Hirsch,Solveig Fenet,Vasantha Muthuswamy Pdf
This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.
Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Publisher : National Academies Press Page : 445 pages File Size : 49,6 Mb Release : 2004-07-09 Category : Medical ISBN : 9780309133388
Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Chinese University of Hong Kong,Chinese University of Hong Kong. Clinical Trials Centre,Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc
Author : Chinese University of Hong Kong,Chinese University of Hong Kong. Clinical Trials Centre,Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc Publisher : Unknown Page : 153 pages File Size : 41,7 Mb Release : 2010 Category : Clinical trials ISBN : 9881904110
Reviewing Clinical Trials by Chinese University of Hong Kong,Chinese University of Hong Kong. Clinical Trials Centre,Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc Pdf
The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
Patient-centered medicine is not an illness-centered, a physician-centered, or a hospital-centered medicine approach. In this book, it is aimed at presenting an approach to patient-centered medicine from the beginning of life to the end of life. As indicated by W. Osler, "It is much more important to know what sort of a patient has a disease than what sort of a disease a patient has." In our day, if the physicians and healthcare professionals could consider more than the diseased organ and provide healthcare by comforting the patients by respecting their values, beliefs, needs, and preferences; informing them and their relatives at every stage; and comforting the patients physically by controlling the pain and relieving their worries and fears, patients obeying the rules of physicians would become patients with high adaptation and participation to the treatment.
Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller
Author : Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller Publisher : OUP USA Page : 848 pages File Size : 46,8 Mb Release : 2011-02 Category : Medical ISBN : 9780199768639
The Oxford Textbook of Clinical Research Ethics by Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller Pdf
The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
Human Subjects Research Regulation by I. Glenn Cohen,Holly Fernandez Lynch Pdf
Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects. The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government's first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection. After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts. Contributors Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf
This updated second edition of At Risk in America provides a detailed analysis of those key population groups most vulnerable to disease and injury in the United States today-including homeless persons, refugees and immigrants, people living with AIDS, alcohol and substance abusers, high-risk mothers and infants, victims of family or other violence, and the chronically or mentally ill. Lu Ann Aday reviews the major theories and knowledge concerning these at-risk groups and offers new approaches and methodologies for tracing the social determinants and societal influences on health. She examines the specific health needs and risks faced by these groups, their experience in the health care system, the current policies and programs that serve them, and the research and policy initiatives that might be undertaken to help reduce their vulnerability.
Council for International Organizations of Medical Sciences (CIOMS)
Author : Council for International Organizations of Medical Sciences (CIOMS) Publisher : World Health Organization Page : 0 pages File Size : 48,9 Mb Release : 2017-01-31 Category : Bioethics ISBN : 9290360887
International Ethical Guidelines for Health-Related Research Involving Humans by Council for International Organizations of Medical Sciences (CIOMS) Pdf
"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Researching the Vulnerable by Pranee Liamputtong Pdf
′This book is refreshing, both as an addition to the general literature and as a text that considers cultural and social issues in studies relating to improving the situation of vulnerable people.... [T]his book will be a helpful, accessible and interesting resource for novice and experienced researchers alike in a number of fields′ - Nurse Researcher ′Pranee Liamputtong has offered a well organized, clear and accessible work in Researching the Vulnerable...this book can offer very good guidance to the postgraduate student who is willing to focus in qualitative research methods, but also to an experienced researcher who may consider testing out its procedures or eventually is attempting to put into practice innovative qualitative research procedures′ - Sociological Research Online Researching Vunerable People takes as its starting point the particular considerations and sensitivities of being a researcher faced with a subject group at the margins of society, and explores the ethical, practical and methodological implications of working with such groups. Pranee Liamputtong is an experienced textbook author, and in this book she attempts to explore qualitative methods using examples, drawn from around the world, from the wide variety of contexts that might count as ′researching the vulnerable′. Numerous salient points for the conduct of research within vulnerable groups of people, including ethical and moral issues, are considered, and discussed in the context of sensitive and innovative research methods.
