Clinical Trials In Vulnerable Populations

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.

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.

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.

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.

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.

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.

′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.

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.