Download or read book Ethics and adaptive platform trial design in public health emergencies written by World Health Organization and published by World Health Organization. This book was released on 2023-10-03 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: Platform trials, using adaptive methodologies, have played an important role in the research response to COVID-19, and offer prospect of being widely used in future pandemic preparedness and response. As these relatively new methodologies raise a number of ethical and governance challenges, in early 2022 the Health Ethics and Governance Unit of the World Health Organization commissioned five rapid reviews, with the aim of learning from, and building on, experiences during the pandemic. These reviews covered the role and policy impact of adaptive platform trials during COVID-19 https://www.who.int/teams/health-ethics-governance/emergencies-and-outbreaks/platform-trials. The target audiences: the research community, including researchers, research funders, ministries of health and science, research ethics committee and regulators.
Download or read book Evidence Based Practice for Public Health Emergency Preparedness and Response written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-11-28 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: When communities face complex public health emergencies, state local, tribal, and territorial public health agencies must make difficult decisions regarding how to effectively respond. The public health emergency preparedness and response (PHEPR) system, with its multifaceted mission to prevent, protect against, quickly respond to, and recover from public health emergencies, is inherently complex and encompasses policies, organizations, and programs. Since the events of September 11, 2001, the United States has invested billions of dollars and immeasurable amounts of human capital to develop and enhance public health emergency preparedness and infrastructure to respond to a wide range of public health threats, including infectious diseases, natural disasters, and chemical, biological, radiological, and nuclear events. Despite the investments in research and the growing body of empirical literature on a range of preparedness and response capabilities and functions, there has been no national-level, comprehensive review and grading of evidence for public health emergency preparedness and response practices comparable to those utilized in medicine and other public health fields. Evidence-Based Practice for Public Health Emergency Preparedness and Response reviews the state of the evidence on PHEPR practices and the improvements necessary to move the field forward and to strengthen the PHEPR system. This publication evaluates PHEPR evidence to understand the balance of benefits and harms of PHEPR practices, with a focus on four main areas of PHEPR: engagement with and training of community-based partners to improve the outcomes of at-risk populations after public health emergencies; activation of a public health emergency operations center; communication of public health alerts and guidance to technical audiences during a public health emergency; and implementation of quarantine to reduce the spread of contagious illness.
Download or read book Bayesian Adaptive Methods for Clinical Trials written by Scott M. Berry and published by CRC Press. This book was released on 2010-07-19 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adapti
Download or read book Reviewing Clinical Trials written by Chinese University of Hong Kong and published by . This book was released on 2010 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Global Health Risk Framework written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-05-06 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak. In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Workshop on Research and Development of Medical Products are summarized in this report.
Download or read book Global Health Research in an Unequal World written by Gemma Aellah and published by Cabi. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title is available as an Open Access eBook for free from CABI's eBook platform. Visit their website at www.cabi.org/cabebooks/ebook/20163308509. This book is a collection of fictionalized case studies of everyday ethical dilemmas and challenges encountered in the process of conducting global health research in places where the effects of political and economic inequality are particularly evident. It is a training tool to fill the gap between research ethics guidelines and their implementation "on the ground." The cases focus on "relational" ethics: ethical actions and ideas that continuously emerge through relations with others, rather than being determined by bioethics regulation. They are based on stories and experiences collected by a group of social anthropologists who have worked with leading transnational medical research organizations across Africa in the past decade. Accompanied by guidelines, discussion questions and selected further readings, the book provides a flexible resource for training and self-study for people engaged in health research with, universities, international collaborative sites and NGOs - and for everyone interested in the realities of global health research today.
Download or read book Implementation Research in Health written by David H. Peters and published by World Health Organization. This book was released on 2013 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.
Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
Download or read book Social Isolation and Loneliness in Older Adults written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-05-14 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: Social isolation and loneliness are serious yet underappreciated public health risks that affect a significant portion of the older adult population. Approximately one-quarter of community-dwelling Americans aged 65 and older are considered to be socially isolated, and a significant proportion of adults in the United States report feeling lonely. People who are 50 years of age or older are more likely to experience many of the risk factors that can cause or exacerbate social isolation or loneliness, such as living alone, the loss of family or friends, chronic illness, and sensory impairments. Over a life course, social isolation and loneliness may be episodic or chronic, depending upon an individual's circumstances and perceptions. A substantial body of evidence demonstrates that social isolation presents a major risk for premature mortality, comparable to other risk factors such as high blood pressure, smoking, or obesity. As older adults are particularly high-volume and high-frequency users of the health care system, there is an opportunity for health care professionals to identify, prevent, and mitigate the adverse health impacts of social isolation and loneliness in older adults. Social Isolation and Loneliness in Older Adults summarizes the evidence base and explores how social isolation and loneliness affect health and quality of life in adults aged 50 and older, particularly among low income, underserved, and vulnerable populations. This report makes recommendations specifically for clinical settings of health care to identify those who suffer the resultant negative health impacts of social isolation and loneliness and target interventions to improve their social conditions. Social Isolation and Loneliness in Older Adults considers clinical tools and methodologies, better education and training for the health care workforce, and dissemination and implementation that will be important for translating research into practice, especially as the evidence base for effective interventions continues to flourish.
Download or read book Research Ethics in Epidemics and Pandemics written by Susan Bull and published by Springer Nature. This book was released on 2023 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: Zusammenfassung: This open access casebook addresses complex and important ethical challenges arising when health-related research in conducted in the context of epidemics and pandemics. This book provides contextually-rich real-world case studies illustrating research ethics issues encountered by researchers, ethics reviewers and regulators around the globe during the COVID-19 pandemic. The accompanying commentaries outline relevant conceptual approaches and ethical considerations. These promote understanding and reflection on relevant ethical issues, ethical approaches and competing considerations in a manner supporting thoughtful evaluation of their implications for practice. As such the casebook is relevant to academic and professional audiences with an interest in global health, research ethics, and outbreaks and epidemics
Download or read book Guidance for Managing Ethical Issues in Infectious Disease Outbreaks written by World Health Organization and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Infectious disease outbreaks are frequently characterized by scientific uncertainty, social and institutional disruption, and an overall climate of fear and distrust. Policy makers and public health professionals may be forced to weigh and prioritize potentially competing ethical values in the face of severe time and resource constraints. This document seeks to assist policy-makers, health care providers, researchers, and others prepare for outbreak situations by anticipating and preparing for the critical ethical issues likely to arise."--Publisher.
Download or read book Global Health and the Future Role of the United States written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-10-05 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: While much progress has been made on achieving the Millenium Development Goals over the last decade, the number and complexity of global health challenges has persisted. Growing forces for globalization have increased the interconnectedness of the world and our interdependency on other countries, economies, and cultures. Monumental growth in international travel and trade have brought improved access to goods and services for many, but also carry ongoing and ever-present threats of zoonotic spillover and infectious disease outbreaks that threaten all. Global Health and the Future Role of the United States identifies global health priorities in light of current and emerging world threats. This report assesses the current global health landscape and how challenges, actions, and players have evolved over the last decade across a wide range of issues, and provides recommendations on how to increase responsiveness, coordination, and efficiency â€" both within the U.S. government and across the global health field.
Download or read book Strategies to Improve Cardiac Arrest Survival written by Institute of Medicine and published by National Academies Press. This book was released on 2015-09-29 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cardiac arrest can strike a seemingly healthy individual of any age, race, ethnicity, or gender at any time in any location, often without warning. Cardiac arrest is the third leading cause of death in the United States, following cancer and heart disease. Four out of five cardiac arrests occur in the home, and more than 90 percent of individuals with cardiac arrest die before reaching the hospital. First and foremost, cardiac arrest treatment is a community issue - local resources and personnel must provide appropriate, high-quality care to save the life of a community member. Time between onset of arrest and provision of care is fundamental, and shortening this time is one of the best ways to reduce the risk of death and disability from cardiac arrest. Specific actions can be implemented now to decrease this time, and recent advances in science could lead to new discoveries in the causes of, and treatments for, cardiac arrest. However, specific barriers must first be addressed. Strategies to Improve Cardiac Arrest Survival examines the complete system of response to cardiac arrest in the United States and identifies opportunities within existing and new treatments, strategies, and research that promise to improve the survival and recovery of patients. The recommendations of Strategies to Improve Cardiac Arrest Survival provide high-priority actions to advance the field as a whole. This report will help citizens, government agencies, and private industry to improve health outcomes from sudden cardiac arrest across the United States.
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Modern Approaches to Clinical Trials Using SAS written by Sandeep Menon and published by SAS Institute. This book was released on 2015-12-09 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.
Download or read book The Theory of Response Adaptive Randomization in Clinical Trials written by Feifang Hu and published by John Wiley & Sons. This book was released on 2006-09-29 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents a firm mathematical basis for the use of response-adaptive randomization procedures in practice The Theory of Response-Adaptive Randomization in Clinical Trials is the result of the authors' ten-year collaboration as well as their collaborations with other researchers in investigating the important questions regarding response-adaptive randomization in a rigorous mathematical framework. Response-adaptive allocation has a long history in biostatistics literature; however, largely due to the disastrous ECMO trial in the early 1980s, there is a general reluctance to use these procedures. This timely book represents a mathematically rigorous subdiscipline of experimental design involving randomization and answers fundamental questions, including: How does response-adaptive randomization affect power? Can standard inferential tests be applied following response-adaptive randomization? What is the effect of delayed response? Which procedure is most appropriate and how can "most appropriate" be quantified? How can heterogeneity of the patient population be incorporated? Can response-adaptive randomization be performed with more than two treatments or with continuous responses? The answers to these questions communicate a thorough understanding of the asymptotic properties of each procedure discussed, including asymptotic normality, consistency, and asymptotic variance of the induced allocation. Topical coverage includes: The relationship between power and response-adaptive randomization The general result for determining asymptotically best procedures Procedures based on urn models Procedures based on sequential estimation Implications for the practice of clinical trials Useful for graduate students in mathematics, statistics, and biostatistics as well as researchers and industrial and academic biostatisticians, this book offers a rigorous treatment of the subject in order to find the optimal procedure to use in practice.
Download or read book Handbook for Good Clinical Research Practice GCP written by World Health Organization and published by . This book was released on 2005 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt:
