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Since its inception 14 years ago, CAPRISA has conducted numerous clinical studies that have influenced international TB-HIV treatment guidelines as well as HIV prevention through innovations in the microbicide and vaccine fields. This book provides a historical account of how each of CAPRISA’s high impact studies was created, developed, implemented, analysed and communicated. In doing so, the reader is taken on a journey that provides glimpses into the genesis of research ideas and how this ultimately leads to a range of HIV prevention and treatment studies that have impacted the global response to the HIV and TB epidemics. Comprised of 5 sections, the book details the following: HIV epidemic in South Africa and the establishment of a research centre to undertake clinical, epidemiological and laboratory research on HIV. CAPRISA’s clinical trials on HIV and HSV-2 prevention. These studies investigated the impact of tenofovir gel as topical antiretroviral pre-exposure prophylaxis (PrEP), implementation of topical PrEP through family planning clinics, conditional cash incentives for HIV prevention, HIV vaccines, and passive immunisation with broadly neutralising antibodies. CAPRISA’s research on the treatment of HIV and TB co-infection. A review of the major scientific findings from the CAPRISA studies on acute infection and genital mucosal immunology. Essential support activities for the conduct of clinical trials, including research laboratories and pharmacies, as well as establishing effective communication and sustainable structures for community engagement to maintain effective and respectful partnerships with participating communities. The book concludes with a chapter about the challenges facing future HIV prevention and treatment trials. The CAPRISA Clinical Trials: HIV Treatment and Prevention is a resource for undergraduate and postgraduate students, health care providers, doctors, decision-makers and researchers who are seeking guidance and insights on clinical trials – their creation, conduct and impact.
"The book is a balanced and comprehensive treatment of an important social issue. It is accessible to the general reader and belongs in public as well as academic libraries." -- Religious Studies Review "Painstaking analysis of the knotty ethical problems involved in human-subjects research, and a well-thought-out proposal for a community approach to conducting field trials for an HIV vaccine.... Highly recommended for medical ethicists and anyone concerned about the AIDS epidemic and how HIV research is conducted."Â -- Kirkus Reviews "... a carefully reasoned account of how research for and trial of a preventive vaccine differ from the methods used to discover a therapy."Â -- Booklist "I highly recommend reading this book which I would attest to be a thrilling, ethically challenging, and informative descent into the allopathic solution." -- Ryan Hosken, Bastyr University Library Newsletter "As the scientific effort to produce an efficacious vaccine continues, [Grady's] work provides an ethical compass that will guide us well, regardless of where phase III HIV vaccine trials ultimately occur." -- Journal of the American Medical Association "Highly recommended... " -- AIDS Book Review Journal "A remarkable treatment of a most difficult and complex subject... Grady's book is of special merit because it is simple, readable, and understandable, while conveying in-depth perceptions that are critical to the reader. A useful and essential reference work for those who would engage in the initiative to bring about a resolution of a mighty human health problem." -- Maurice R. Hilleman, Ph.D., D.Sc., Director, Merck Institute for Therapeutic Research "Dr. Grady's important study captures the complexity of the search for an AIDS vaccine with startling clarity. Her insights into the full range of forces that shape our national response to AIDS vaccine development should read like signposts to vaccinologists, AIDS community activists, and most importantly, the Public Health Service. An impressive contribution." -- Derek Hodel, Gay Men's Health Crisis "This book is recommended to medical ethicists, those involved in non-HIV vaccine trials, and all persons involved in HIV vaccine trials, including investigators, sponsors, study subjects and communities at risk." -- Journal of Health Politics, Policy and Law The creation of a vaccine now seems the best hope for controlling AIDS. Yet developing and testing an HIV vaccine raises a host of difficult ethical issues. These concerns are the focus of this timely and important book. Essential reading for everyone interested in ethics and the conduct of HIV vaccine research.
This book provides a comprehensive review of the major barriers to HIV cure and vaccine. It covers the fundamental virology and immunology leading to HIV transmission, protection from infection and long term HIV persistence on antiretroviral therapy. In addition, strategies being tested to eliminate persistent HIV and the rational design of vaccines to induce protective immunity are covered. This book also discusses the challenges related to the design of clinical trials for testing the safety and efficacy of these innovative approaches. This book will provide a systematic overview and also discuss controversial issues for researchers in virology and immunology, as well as practicing physicians, and scientists in the pharmaceutical industry.
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
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.
This book is a practical guide in understanding how to prevent HIV transmission, to recognize risk behaviors, and to add something else to their repertoires. It aims to empower clinicians and provide a sense of security and competence with the recognition and understanding of some of the psychiatric illnesses that complicate and perpetuate the HIV pandemic that continue to persist throughout every area of the world despite the magnitude of the progress that has transformed the illness from a rapidly fatal to chronic illness that is no longer life-limiting. Missing in most of the literature on HIV is the subtle, and sometimes not so subtle, contribution of psychiatric symptoms, psychiatric illness, and risk behaviors that drive the pandemic and serve as catalysts for new infections. This practical guide provides state-of-the-art understanding of not only prevention but also a way to recognize risk behaviors, psychiatric symptoms, and psychiatric illnesses that will demystify and decode the sometimes enigmatic and frustrating reasons for nonadherence with diagnostic procedures and life-saving treatments and care. All behaviors and pathology are covered as well as the resources and treatments available. The goal of this text is to refresh knowledge on the current state of psychiatric illness management among people living with HIV, to provide a concise volume on the psychiatric aspects of HIV prevention and treatment that substantially impact the overall care of the patient, and to help understand the psychiatric catalysts of the pandemic Written by experts in the field, HIV Psychiatry: A Practical Guide for Clinicians provides enduring guidance to medical and other professionals caring for complicated clinical patients as they face ongoing challenges in working with persons with HIV and AIDS.
The Pocket Book is for use by doctors nurses and other health workers who are responsible for the care of young children at the first level referral hospitals. This second edition is based on evidence from several WHO updated and published clinical guidelines. It is for use in both inpatient and outpatient care in small hospitals with basic laboratory facilities and essential medicines. In some settings these guidelines can be used in any facilities where sick children are admitted for inpatient care. The Pocket Book is one of a series of documents and tools that support the Integrated Managem.
This book examines the impact of pediatric HIV on children, adolescents, and their families. Beginning with an overview of pediatric HIV epidemiology, it traces the medical, psychological, and social dimensions of HIV through the trajectory of childhood and youth. It examines the latest research on a wide range of topics, including treatment adherence, cultural, legal, and ethical issues, and HIV stigma and its reduction. Chapters offer expert recommendations for clinicians working with children with HIV as well as researchers studying pediatric HIV. In addition, the book also discusses daily concerns associated with pediatric HIV, such as disease management, coping, access to services, risk prevention, and health promotion. Topics featured in this book include: The impact of pediatric HIV on families. Psychosocial considerations for children and adolescents with HIV. HIV prevention and intervention in the school setting. HIV disclosure in pediatric populations. How to design effective evidence-based HIV risk-reduction programs for adolescents. A Clinical Guide to Pediatric HIV is a must-have resource for researchers, clinicians, and graduate students in child and school psychology, social work, and public health as well as pediatric medicine, nursing, epidemiology, anthropology, and other related disciplines.
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
The book focuses on HIV/AIDS prevention and treatment strategies in resource-poor settings. Contributors include HIV/AIDS researchers and public health administrators from the US, Africa, China, and Thailand. Several chapters, written by local health officials, take a close look at AIDS prevention and treatment in China at the community level. Other chapters cover issues of treatment scale-up, drug resistance, and mother-to-child transmission in Southern Africa and Thailand, and offer lessons learned for researchers in other developing countries. Overall the aim of this book is to bring some of the latest issues to the fore, and to foster exchange and collaboration between AIDS researchers in developing countries. This book grew out of an annual conference held in China and organized by the Harvard School of Public Health, and could possibly become the first volume of a series.