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The number of people infected with HIV or living with AIDS is increasing at unprecedented rates as various scientists, organizations, and institutions search for innovative solutions to combating and preventing the disease. At the request of the Bill & Melinda Gates Foundation, Methodological Challenges in Biomedical HIV Prevention Trials addresses methodological challenges in late-stage nonvaccine biomedical HIV prevention trials with a specific focus on microbicide and pre-exposure prophylaxis trials. This book recommends a number of ways to improve the design, monitoring, and analysis of late-stage clinical trials that evaluate nonvaccine biomedical interventions. The objectives include identifying a beneficial method of intervention, enhancing quantification of the impact, properly assessing the effects of using such an intervention, and reducing biases that can lead to false positive trial results. According to Methodological Challenges in Biomedical HIV Prevention Trials, the need to identify a range of effective, practical, and affordable preventive strategies is critical. Although a large number of promising new HIV prevention strategies and products are currently being tested in late-stage clinical trials, these trials face a myriad of methodological challenges that slow the pace of research and limit the ability to identify and fully evaluate effective biomedical interventions.
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.
Today, perhaps more than ever, health care is a key item on the nation's agenda. Government policy makers, health professionals, scientists, industrial and civic leaders, patient advocates, and private citizens across the social spectrum are focusing on how best to obtain a high-quality health system that is efficient and affordable in its operation and that functions well for everyone. The Institute of Medicine (IOM) regularly considers this challenge from a variety of perspectives. Recent efforts have focused on improving the organization and operation of the nation's largest health agency; working to assess what diagnostic, therapeutic, and preventive services work best; gauging the overall health of the nation's population; and identifying ways to build an even stronger foundation of evidence-based medicine that effectively captures the promise of scientific discovery and technological innovation and enables doctors, nurses, and other health professionals to provide the right care for the right patient at the right time. The body of this book illustrates the work of IOM committees in selected, major areas in recent years, followed by a description of IOM's convening and collaborative activities and fellowship programs. The last section provides a comprehensive bibliography of IOM reports published since 2007.
With its focus on the offshore randomized control trials of a Pre-Exposure Prophylactic pill (PrEP) for preventing HIV infection, the volume develops a sustained analysis of the complex, virtual and topological dimensions of the expectations, ethics and evidence that surround the innovation of PrEP.
With contributions from leading authorities in the field, this text explores the major health challenges & conditions that specifically affect women.
At its core, epidemiology is concerned with changes in health and disease. The discipline requires counts and measures: of births, health disorders, and deaths, and in order to make sense of these counts it requires a population base defined by place and time. Epidemiology relies on closely defined concepts of cause - experimental or observational - of the physical or social environment, or in the laboratory. Epidemiologists are guided by these concepts, and have often contributed to their development. Because the disciplinary focus is on health and disease in populations, epidemiology has always been an integral driver of public health, the vehicle that societies have evolved to combat and contain the scourges of mass diseases.In this book, the authors trace the evolution of epidemiological ideas from earliest times to the present. Beginning with the early concepts of magic and the humors of Hippocrates, it moves forward through the dawn of observational methods, the systematic counts of deaths initiated in 16th-century London by John Graunt and William Petty, the late 18th-century Enlightenment and the French Revolution, which established the philosophical argument for health as a human right, the national public health system begun in 19th-century Britain, up to the development of eco-epidemiology, which attempts to re-integrate the fragmented fields as they currently exist. By examining the evolution of epidemiology as it follows the evolution of human societies, this book provides insight into our shared intellectual history and shows a way forward for future study.
One of the most promising new approaches for the prevention of HIV transmission, particularly for developing countries, involves topical, self-administered products known as microbicides. The development of microbicides is a long and complicated process, and this volume provides an overview of all the critical areas, from the selection of appropriate candidate molecules and their formulation, preclinical and clinical testing for safety and efficacy, strategies for product registration and finally, issues associated with product launch, distribution and access. The book will prove valuable to both those working in the field and all others who are interested in learning more about this product class, which has the potential to significantly impact the future of this devastating epidemic.
Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings.
In the space of one generation major changes have begun to take place in the field of human reproduction. A rapid increase in the control of fertility and the understanding and treatment of sexual health issues have been accompanied by an emerging threat to reproductive function linked to increasing environmental pollution and dramatic changes in lifestyle. Organised around four key themes, this book provides a valuable review of some of the most important recent findings in human reproductive ecology. Major topics include the impact of the environment on reproduction, the role of physical activity and energetics in regulating reproduction, sexual maturation and ovulation assessment and demographic, health and family planning issues. Both theoretical and practical issues are covered, including the evolution and importance of the menopause and the various statistical methods by which researchers can analyse characteristics of the menstrual cycle in field studies.