Download or read book AIDS HIV Clinical Trial Handbook written by and published by . This book was released on 1985 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Trials Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2009-06-17 with total page 1247 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book HIV Vaccine Handbook written by Bill Snow and published by . This book was released on 1999 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Trials Handbook written by Curtis L. Meinert and published by John Wiley & Sons. This book was released on 2012-10-10 with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt: A systematic approach to all aspects of designing and conducting clinical trials The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials—teaching them how to simplify the process and avoid costly mistakes. The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include: Protocols for drug masking, controls, and treatment randomization Consent, enrollment, eligibility, and follow-up procedures Different types of sample size design and data collection and processing Working with study centers, research staff, and various committees Monitoring treatment effects and performance, and ensuring quality control Data analysis and access policies for study data and documents Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.
Download or read book Designing HIV AIDS Intervention Studies written by Andrew A. Fisher and published by Population. This book was released on 2002-01-01 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The AmFAR AIDS Handbook written by Darrell E. Ward and published by W. W. Norton & Company. This book was released on 1999 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the latest research on HIV and AIDS, including information on combined drug therapy, protease inhibitors, and other treatment options.
Download or read book A Media Handbook for HIV Vaccine Trials for Africa written by Yinka Adeyemi and published by World Health Organization. This book was released on 2001 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Legal and Ethical Aspects of HIV Related Research written by Emmanuelle E. Wollmann and published by Springer Science & Business Media. This book was released on 2005-11-24 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: The motivation and inspiration for this book come directly from expe- ences with clients during the years that I practiced HIV-related law at the Legal Aid Society of San Diego, Inc. The issues discussed in this work reflect issues that arose on a recurring basis with clients participating in HIV research studies, with investigators calling for guidance on the legal implications of particular aspects of their proposed studies, and with research institutions and health care facilities struggling to make sense of legal maneuvers aimed at obtaining the records of their HIV-infected patients. It is impossible to thank each of these persons individually for their provocative questions and their insights. The discussion of ethical and legal issues relating to the design of clinical trials reflects questions raised during discussions with Donald J. Slymen, Ph.D. Don was one of the first researchers, in my realm of experience, to pay close attention to ethical concerns, and I am greatly appreciative of his contribution to both my professional growth and the development of various scenarios discussed in this text. The portions of this text dealing with confidentiality are the result of many hours of thoughtful discussion and analysis with Penn Lerblance, J.D., now deceased and still missed. Penn and I often participated together as presenters of in-service training programs for health prof- sionals. Penn addressed discrimination, and I focused on confidentiality.
Download or read book The Social Impact of AIDS in the United States written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.
Download or read book A Comprehensive and Practical Guide to Clinical Trials written by Delva Shamley and published by Academic Press. This book was released on 2017-06-07 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists
Download or read book Clinical Trials written by Timothy M. Pawlik and published by Springer Nature. This book was released on 2020-03-10 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.
Download or read book The Search for an AIDS Vaccine written by Christine Grady and published by Indiana University Press. This book was released on 1995-05-22 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
Download or read book AIDS Clinical Trials written by Dianne M. Finkelstein and published by Wiley-Liss. This book was released on 1995-07-28 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: AIDS CLINICAL TRIALS Edited by Dianne M. Finkelstein and David A. Schoenfeld Conducting trials for new drugs or regimens for the treatment of HIV or AIDS presents unique challenges to statisticians and clinical investigators. Not only must they have a clear understanding of the relevant regulatory issues and methods of statistical analysis, but they must also deal with various medical and social pressures that further complicate the design and implementation of clinical trials. AIDS Clinical Trials addresses the critical scientific, clinical, and regulatory issues involved in AIDS drug development and evaluation. The book provides the reader with detailed guidelines on the essential statistical methods for data analysis in AIDS clinical trials, and helps foster an understanding of the complex medical and social concerns surrounding AIDS research. The text opens with discussions of the natural history of HIV and its implications for trials, then goes on to offer an overview of the evaluation process for new drugs— considering in depth the perspectives of the pharmaceutical industry and the U.S. Food and Drug Administration. Subsequent chapters in the text deal with specific aspects of planning and conducting AIDS clinical trials, encompassing everything from protocol development and data issues to quality of life, compliance, and economic considerations in AIDS clinical research. Some of the topics covered in the book include: Design and analysis of Phase I and Phase I/II clinical trials in AIDS The uses of CD4 lymphocyte count to evaluate therapy for HIV disease Sample size calculations for failure time data Design and analysis of equivalence trials Testing drug combinations Pediatric, obstetrical, and gynecological issues in AIDS clinical trials Interim monitoring Evaluation of HIV vaccines The use of surveillance and cohort studies for evaluating AIDS therapies AIDS Clinical Trials is a much needed practical manual on the design and implementation of trials for new drugs designed to treat AIDS and its complications. It is essential reading for all AIDS physicians, biostatisticians, and clinical researchers testing the viability of new treatments— and an ideal resource for statisticians with medical, industrial, or government agencies concerned with evaluating clinical data on the safety and efficacy of prophylactic and therapeutic agents for AIDS/HIV.
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 236 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.
Download or read book The CAPRISA Clinical Trials HIV Treatment and Prevention written by Quarraisha Abdool Karim and published by Springer. This book was released on 2018-04-29 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book HIV Vaccines and Cure written by Linqi Zhang and published by Springer. This book was released on 2018-07-20 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Fierce Medicines Fragile Socialities written by Dominik Mattes and published by Berghahn Books. This book was released on 2019-08-01 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Set in Tanga, a city on the Tanzanian Swahili coast, Dominik Mattes examines the implementation of antiretroviral HIV-treatment (ART) in the area, exploring the manifold infrastructural and social fragilities of treatment provision in public HIV clinics as well as patients’ multi-layered struggles of coming to terms with ART in their everyday lives. Based on extensive ethnographic fieldwork, the book shows that, notwithstanding the massive rollout of ART, providing treatment and living a life with HIV in settings like Tanga continue to entail social, economic, and moral challenges and long-term uncertainties, which contradict the global rhetoric of the “normalization of HIV”.
