Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise

"Medicine at the Border" explores the pressing issues of border control and infectious disease in the nineteenth, twentieth and twenty-first centuries. The book places world health in world history, microbes and their management in globalization, and disease in the history of international relations, bringing together leading scholars on the history and politics of global health. The authors show how infectious disease has been central to the political, legal and commercial history of nationalism, colonialism and internationalism over the modern period.

This volume brings together the world's leading experts on urban and transport planning, environmental exposures, physical activity, health and health impact assessment to discuss challenges and solutions in cities. The book provides a conceptual framework and work program for actions and outlines future research needs. It presents the current evidence-base, the benefits of and numerous case studies on integrating health and the environment into urban development and transport planning. Within cities there is a considerable variation in the levels of environmental exposures such as ambient air pollution, noise, and temperature, green space availability and physical activity. Many of these exposures, and their adverse health impacts, are related to and are being exacerbated by urban and transport planning and policy. Emerging research suggests that urban and transport planning indicators such as road network, distance to major roads, traffic density, household density, industry, and natural and green space can explain a large proportion of the variability in environmental exposures and therefore represent important and highly modifiable factors. The urban environment is a complex interlinked system. Decision-makers need not only better data on the complexity of factors in environmental and developmental processes affecting human health, but also an enhanced understanding of the linkages between these factors and health effects to determine at which level to target their actions most effectively. In recent years, there also has been a shift from trying to change at the national level to more comprehensive and ambitious actions being developed and implemented at the regional and local levels. Cities have come to the forefront of providing solutions for environmental issues such as climate change, which has co-benefits for health, but yet need better knowledge for wider health-centric action. This book provides the latest and most up-to-date information and studies for academics and practitioners alike.

The public is bombarded daily with reports about risk factors, many conflicting with each other, others accepted as "scientific truth" for awhile, then scientifically disproved, yet others questionable that later prove to be true. Physicians are faced with trying to make sense of those conflicting or questionable results in the scientific literature in order to guide their patients to the best possible decisions. The situation is not much easier for scientists who may waste years of their productive life, and considerable resources, basing their research efforts on what prove to be misleading earlier research findings. What this book does is to present, in non "academese" and with many examples from the general media and scientific journals, a guide to a critical reading of research reports, which, in turn, serves as a guide to researchers as to which approaches are likely to be regarded with raised eyebrows, and what they need to do to generate results that will be taken seriously. This stimulating and helpful book was written for informed consumers and physicians as well as for scientists evaluating the risk research literature or contemplating projects on risk research.

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

This book offers a radically different perspective on the topic of health inequity. Carey, Tai, and Griffiths use Perceptual Control Theory (PCT) to deconstruct current approaches to understanding, investigating, and addressing problems of health inequity. In the book, the authors propose that health inequity is not a problem per se. Disrupted control, they argue, is the problem that needs to be addressed. From this perspective, research, policy, and health practices directed at addressing health inequity in isolation will offer only partial solutions to the problems created by disrupted control. Addressing problems of disrupted control directly, however, has the potential to entirely resolve issues that are created by health inequity. The authors have extensive clinical and research experience in a wide range of contexts, including: cross-cultural settings; rural, remote, and underserved communities; community mental health settings; prisons; schools; and psychiatric wards. Drawing on these diverse experiences, the authors describe how adopting a Perceptual Control Theory perspective might offer promising new directions for researchers and practitioners who have an interest in addressing issues of inequity and social justice. With a Foreword written by Professor Neil Gilbert this book will provide fresh insights for academics, practitioners, and policymakers in the fields of public health, psychology, social policy, and healthcare.

This book includes research articles and expository papers on the applications of artificial intelligence and big data analytics to battle the pandemic. In the context of COVID-19, this book focuses on how big data analytic and artificial intelligence help fight COVID-19. The book is divided into four parts. The first part discusses the forecasting and visualization of the COVID-19 data. The second part describes applications of artificial intelligence in the COVID-19 diagnosis of chest X-Ray imaging. The third part discusses the insights of artificial intelligence to stop spread of COVID-19, while the last part presents deep learning and big data analytics which help fight the COVID-19.

This book allows readers to gain an in-depth understanding of the role of real-world data in pharmacoepidemiology, and highlights the strengths and limitations of the respective databases with regard to pharmacoepidemiological research. Over the past decade, the increasing use of real-world data in pharmacoepidemiological research has been accompanied by a growing recognition of the value of real-world evidence in clinical and regulatory decision-making. Electronic healthcare databases allow analyses of drug and vaccine utilization in routine care after approval, as well as investigations of their comparative effectiveness and safety. They are especially useful for the identification of rare risks and rare drug exposures over long periods of time, and as such sustainably extend the basis for drug safety research. This book provides an introduction to the role of real-world data in pharmacoepidemiological research and the main developments in the last 15 years. It also offers a comprehensive overview of the general classification characteristics of databases, together with their strengths and limitations, and a detailed description of 21 individual databases, written by professionals who work with or maintain them.

The most feared attribute of the human pathogen "Vibrio cholerae" is its ability to cause outbreaks that spread like wildfire, completely overwhelming public health systems and causing widespread suffering and death. This volume starts with a description of the contrasting patterns of outbreaks caused by the classical and El Tor biotypes of "V. cholerae." Subsequent chapters examine cholera outbreaks in detail, including possible sources of infection and molecular epidemiology on three different continents, the emergence of new clones through the bactericidal selection process of lytic cholera phages, the circulation and transmission of clones of the pathogen during outbreaks and novel approaches to modeling cholera outbreaks. A further contribution deals with the application of the genomic sciences to trace the spread of cholera epidemics and how this information can be used to control cholera outbreaks. The book closes with an analysis of the potential use of killed oral cholera vaccines to stop the spread of cholera outbreaks.

Encephalitis lethargica ('sleeping sickness') was a mysterious disorder that swept the world in the decade following the First World War, before disappearing without its cause having been identified. Around 85% of its victims, predominantly children, adolescents and younger adults, survived the acute disorder, but most developed severe neurological syndromes, particularly severe post-encephalitic parkinsonism and other severe motor abnormalities, that incapacitated them for the remainder of their lives. Despite its brief history, encephalitis lethargica played a major role in a variety medical discussions between the two World Wars, as this epitome of neuropsychiatric disease - attacking both motor and mental functions - appeared just as the separation of neurology and psychiatry had reached a critical point. Encephalitis lethargica sufferers presented an unprecedented combination of neurologic and psychiatric symptoms - including previously puzzling phenomena primarily associated with schizophrenia and hysteria, as well as behavioral changes and attention deficit disorders in children - that not only underscored the unity of mind and movement in the CNS, but also illuminated the critical role played by subcortical structures in consciousness and other higher mental functions that had formerly been associated with the soul and more recently presumed to be localized to the human cerebral cortex. Encephalitis lethargica exerted a greater influence on clinical and theoretic neuroscientific thought between the two World Wars than any other single disorder and had an enduring impact upon neurology and psychiatry. This book will be of interest to an educated audience active or interested in clinical (neurology, psychiatry, psychology) or laboratory neuroscience, particularly those interested in neuropsychiatry, as well as to those interested in the history of the biomedical sciences.

Down the ages, war epidemics have decimated the fighting strength of armies, caused the suspension and cancellation of military operations, and have brought havoc to the civil populations of belligerent and non-belligerent states alike. This book examines the historical occurrence and geographical spread of infectious diseases in association with past wars. It addresses an intrinsically geographical question: how are the spatial dynamics of epidemics influenced by military operations and the directives of war? The term historical geography in the title indicates the authors' primary concern with qualitative analyses of archival source materials over a 150-year time period from 1850, and this is combined with quantitative analyses less frequently associated with historical studies. Written from the viewpoints of historical geography, epidemiology, and spatial analysis, this book examines in four parts the historical occurrence and geographical spread of infectious diseases in association with wars. Part I: War and Disease, surveys war-disease associations from early times to 1850. Part II: Temporal Trends studies time trends since 1850. Part III: A Regional Pattern of War Epidemics, examines grand themes in the war-disease complex. Part IV: Prospects, considers a series of war-related issues of epidemiological significance in the twenty-first century.

Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations.

This book guides through the fascinating world of viruses and makes readers enjoy science in an accessible way. Virologist and author Professor Van Wilson imparts knowledge about what viruses are, how they work, and how much they impact life on Earth. The book equips the reader with the scientific basics behind virus function and presents the historic milestones of virus research and discovery. Well-known viruses such as HIV or Influenza are tackled alongside novel pathogens like coronavirus SARS-CoV-2. Professor Wilson explores where they come from and how they impact our society. Last but not least the book provides exciting insights into how our immune system reacts to different viruses and how vaccines contribute to conquer pandemics. While scientifically informative, this book makes the field of virology understandable to a lay audience and encourages readers to further thinking. And more importantly, it conveys the wonder, beauty, and mystery of these ubiquitous, microscopic marvels. This book addresses anyone interested in understanding the principles of virology, viral diseases, or the impact of viruses on human societies.

Congenital malformations are worldwide occurrences striking in every condition of society. These severe physical abnormalities which are present at birth and affecting every part of the body happen more often than usually realized, once in every 33 births. The most common, after heart defects, are those of the neural tube (the brain and spinal cord) which happen in as many as one in every 350 births. They have been noted as curiousities in man and beast throughout recorded history and received great attention in our time by various fields of study, for example, their faulty prenatal development by embryologists, familial patterns by geneticists, causation by environmentalists and variability by population scientists.

Attention turned much in recent years to the relation of these malformations to deficiency of a particular dietary ingredient, folic acid, a subject this book analyzes in depth. The greatest conundrum of all, which this latest matter like so much else hinges on, is the amazing fact of the tremendous, almost universal decrease in the frequency of these anomalies since early in the 20th century. The puzzle is 'What can this downward trend possibly mean?' and at bottom 'Whether it is part of a long-term cyclical pattern'. This fascinating biological phenomenon is explored in the book together with various other topics.

- The only textbook that combines an introduction to both the technical operations and conceptual premises of biostatistics - Details the conceptual consequences of the mathematical premises of biostatistics that distort our understanding of holistic and contextual nature of health and medicine - Emphasizes the qualitative and subjective decisions that precede any quantitative analysis - The conceptual implications of biostatistical tools and techniques-such as contriving to fit objects to tools rather than fitting tools to objects-apply equally to statistics in general - Presents univariate, bivariate, and regression analysis through a single common scenario to facilitate student comprehension - Organizes biostatistical tools and techniques into nine configurations that help frame use and rationale of statistical tests and measures - Walks the reader through the technical steps for the examples associated with the nine configurations

This book examines statistical methods and models used in the fields of global health and epidemiology. It includes methods such as innovative probability sampling, data harmonization and encryption, and advanced descriptive, analytical and monitory methods. Program codes using R are included as well as real data examples. Contemporary global health and epidemiology involves a myriad of medical and health challenges, including inequality of treatment, the HIV/AIDS epidemic and its subsequent control, the flu, cancer, tobacco control, drug use, and environmental pollution. In addition to its vast scales and telescopic perspective; addressing global health concerns often involves examining resource-limited populations with large geographic, socioeconomic diversities. Therefore, advancing global health requires new epidemiological design, new data, and new methods for sampling, data processing, and statistical analysis. This book provides global health researchers with methods that will enable access to and utilization of existing data. Featuring contributions from both epidemiological and biostatistical scholars, this book is a practical resource for researchers, practitioners, and students in solving global health problems in research, education, training, and consultation.

The product of six years of collaborative research, this fine biography offers new interpretations of a pioneering figure in anaesthesiology, epidemiology, medical cartography, and public health. It modifies the conventional rags to riches portrait of John Snow by synthesising fresh information about his early life from archival research and recent studies.

It explores the intellectual roots of his commitments to vegetarianism, temperance, and pure drinking water, first developed when he was a medical apprentice and assistant in the north of England. The authors argue that all of Snow's later contributions are traceable to the medical paradigm he imbibed as a medical student in London and put into practice early in his career as a clinician: that medicine as a science required the incorporation of recent developments in its collateral sciences, chiefly anatomy, chemistry, and physiology, in order to understand the causes of disease.

Snow's theoretical breakthroughs in anaesthesia were extensions of his experimental research in respiratory physiology and the properties of inhaled gases. Shortly thereafter, his understanding of gas laws led him to reject miasmatic explanations for the spread of cholera, and to develop an alternative theory in consonance with what was then known about chemistry and the physiology of digestion.

Using all of Snow's writings, the authors follow him when working in his home laboratory, visiting patients throughout London, attending medical society meetings, and conducting studies during the cholera epidemics of 1849 and 1854. The result is a book that demythologises some overly heroic views of Snow by providing a fairer measure of his actual contributions. It will have an impact not only on the understanding of the man but also on the history of epidemiology and medical science.

Authoritative, clear and concise, this highly acclaimed book continues to be an essential text for all medical, surgical and allied health professionals who are seeking a quick and respected guide to systematically reviewing the literature. The third edition features a new chapter on 'Publishing systematic reviews' and numerous new case studies covering the latest developments in the field, including umbrella reviews, reviews of test accuracy, qualitative evidence and prognostic studies, and practice guidelines. The highly experienced authors, who have each contributed to numerous systematic reviews that have helped form policy and practice, ensure that this practical text, which avoids technical jargon, continues to be the reference of choice for all health professionals undertaking literature reviews, including those specializing in epidemiology and public health.

This book presents a broad overview of the challenges posed by COVID-19 in India and its neighboring countries. It studies the differing responses to COVID-19 infections across South Asia, the variegated impact of the pandemic on its societies, communities and economies, and emerging challenges which require an interdisciplinary understanding and analysis. With a range of case studies from India, Bangladesh, Myanmar, Pakistan, Nepal, Bhutan, and Sri Lanka, this book, Analyses the socio-economic impact of the pandemic, including the structural challenges faced by farmers in the agricultural production and migrant workers in the informal sectors; Examines the shifting trends in migration and displacement during the pandemic; Explores the precarity faced by LGBTQ+, transgender, Dalit, tribal, senior citizens, and other marginalized communities during the pandemic; Discusses the gendered impact of the pandemic on women and girls, combining with multiple and intersecting inequalities like race, ethnicity, socio-economic status, age, geographical location, and sexual orientation; Sheds light on the position of health infrastructure and healthcare services across different countries, and the transitions experienced in their education sectors as well, in response to COVID-19. A holistic read on the pandemic, this book will be of interest to scholars and researchers of sociology, medical anthropology, sociology of health, pandemic and health studies, political studies, social anthropology, public policy, and South Asian studies.

1. This volume critically engages with narratives that have dealt with pandemics/epidemics in the past and also in contemporary times to see how these texts present human life coming to terms with and trying to deal with all what pandemics/epidemics entail. 2. It ranges from Camus' The Plague, the writings of Pandita Ramabai, Mary Shelly, to Jack London, Lawrence Wright, and Christina Sweeney Baird, among others. The essays cover a wide spatio-temporal trajectory and make a substantial contribution to mapping the contours of the pandemic in terms of psychology, economics, society, politics and philosophy, thereby offering a variety of perspectives and disciplinarian trajectories. 3. It will be of interest to departments of English literature, social science, gender studies, cultural studies, psychology, society, politics, and philosophy across the US/UK. General readers too will find this exciting as it covers authors from across the world.

Explores text mining and IoT applications for monitoring and controlling smart industrial systems Describes the key principles and techniques for Big-data analytics, security, and optimization for industrial applications. Provides context-aware insights, human-centric industry, smart computing for next-generation industry

Clinical Trials in Cancer provides concise, accessible and practical information on the practicalities of planning, designing, conducting, analysing, reporting, and interpreting phase III clinical trials predominantly, but also single-arm and randomized phase II trials. The book shows clearly how recent developments and current thinking can be implemented. Information on the need to decide and measure realistic target differences in trials, the conduct and interpretation of interim analyses, patient advocacy, good clinical practice, the study of quality of life, the role of meta-analyses, and informed consent and other ethical issues are also covered.

This book will prove invaluable for medical, statistical, and biological cancer researchers, health care professionals, and researchers in the pharmaceutical industry. Trial sponsors, principal investigators, members of data monitoring and trial supervisory committees, specialists invited to provide independent assessments, and many others involved in all aspects of research related to clinical trials should also find this book helpful.

Positively influences career choices within public health Applies basic science to problems raised by the COVID-19 pandemic such as vaccine development and herd immunity Prepares readers with context and tactics for understanding future infectious disease outbreaks Successfully used in college senior health sciences seminar Engaging and balanced treatment of the politicization of public health issues, especially COVID-19

This book is the first one in which basic demographic models are rigorously formulated by using modern age-structured population dynamics, extended to study real-world population problems. Age structure is a crucial factor in understanding population phenomena, and the essential ideas in demography and epidemiology cannot be understood without mathematical formulation; therefore, this book gives readers a robust mathematical introduction to human population studies. In the first part of the volume, classical demographic models such as the stable population model and its linear extensions, density-dependent nonlinear models, and pair-formation models are formulated by the McKendrick partial differential equation and are analyzed from a dynamical system point of view. In the second part, mathematical models for infectious diseases spreading at the population level are examined by using nonlinear differential equations and a renewal equation. Since an epidemic can be seen as a nonlinear renewal process of an infected population, this book will provide a natural unification point of view for demography and epidemiology. The well-known epidemic threshold principle is formulated by the basic reproduction number, which is also a most important key index in demography. The author develops a universal theory of the basic reproduction number in heterogeneous environments. By introducing the host age structure, epidemic models are developed into more realistic demographic formulations, which are essentially needed to attack urgent epidemiological control problems in the real world.

Using "risk" as a conceptual lens, this book analyzes how communities across East Asia responded to the disruption unleashed by the COVID-19 pandemic. The contributors to this book look at how governments, societies, and individuals have perceived, experienced, dealt with and interpreted the pandemic and the transformations it has brought across countries like Japan, South Korea, Taiwan, Vietnam, and the Philippines. They examine pressing concerns such as infodemic, digital health literacy, media cynicism, telework, and digital inequalities in conjunction with issues such as public trust, identity formation, nationalism, and social fragmentation. They look at a wide range of questions relating to communication, mediation, and reactions to the challenges of the pandemic. An insightful resource for scholars of risk studies and of East Asian societies, the book is also a valuable reference for students and researchers of media and communication studies and sociology.