A valuable new edition of the trusted, practical guide to managing data in clinical trials

Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided.

While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements.

Newly featured topics include:

The growing availability of "off-the-shelf" solutions for clinical trials

Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry

The increasing use of the Internet in the collection of data and management of trials

Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines

Development ofStandard Operating Procedures for the conduct of clinical trials

Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

It is impossible to reflect on 2020 without discussing Covid-19. The term, literally meaning corona-(CO) virus (VI) disease (D) of 2019, has become synonymous with "the virus", "corona" and "the pandemic". The impact of the virus on our lives is unprecedented in modern human history, in terms of scale, depth and resilience. When compared to other epidemics that have plagued the world in recent decades, Covid-19 is often referred to as being much more "deadly" and is associated with advances in technology which scientists have described as "revolutionary". From politics to economics, spanning families and continents, Covid-19 has unsettled norms: cultural clashes are intensified, politics are even more polarized, and regional tensions and conflicts are on the rise. Global trade patterns and supply chains are increasingly being questioned and redrawn. The world is being atomized, and individuals are forced to accept the "new normal" in their routines. In an attempt to combat the virus and minimize its detrimental effects, countries have undertaken different preventive strategies and containment policies. Some have successfully curbed the spread of Covid-19, while many others remain in limbo, doing their best to respond to outbreaks in cases. To gain a better understanding of how to fight Covid-19, it is imperative to evaluate the success and failures of these approaches. Under what conditions is an approach successful? When should it be avoided? How can this information be used to avoid future pandemics? This volume offers informative comparative case studies that shed light on these key questions. Each country case is perceptively analyzed and includes a detailed timeline, allowing readers to view each response with hindsight and extrapolate the data to better understand what the future holds. Taken as a whole, this collection offers invaluable insight at this critical juncture in the Covid-19 pandemic.

Covers research on gene drives in Anopheline mosquitoes for malaria control, including aspects from field trials, modelling, risk assessment, regulatory processes, and ethical/political considerations Includes contributions from international leaders in the field Illustrated throughout with figures and references

This is a monograph on the concept of residual life, which is an alternative summary measure of time-to-event data, or survival data. The mean residual life has been used for many years under the name of life expectancy, so it is a natural concept for summarizing survival or reliability data. It is also more interpretable than the popular hazard function, especially for communications between patients and physicians regarding the efficacy of a new drug in the medical field. This book reviews existing statistical methods to infer the residual life distribution. The review and comparison includes existing inference methods for mean and median, or quantile, residual life analysis through medical data examples. The concept of the residual life is also extended to competing risks analysis. The targeted audience includes biostatisticians, graduate students, and PhD (bio)statisticians. Knowledge in survival analysis at an introductory graduate level is advisable prior to reading this book.

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.

Understanding the underlying principles of statistical techniques and effectively applying statistical methods can be challenging for researchers at all stages of their career. This concise, practical guide uses a simple, engaging approach to take scientists and clinicians working in laboratory-based life science and medical research through the steps of choosing and implementing appropriate statistical methods to analyse results. The author draws on her extensive experience of advising students and researchers over the past 30 years, breaking down complex concepts into easy-to-understand units. Practical examples using free online statistical tools are included throughout, with illustrations and diagrams employed to keep jargon to a minimum. Sample size calculations and considerations are covered in depth, and the book refers to types of data from experiments that clinicians and lab-based scientists are likely to encounter. Straightforward, accessible and encouraging throughout, this is a go-to reference for researchers who want to achieve statistical autonomy.

Epidemiology of Thyroid Disorders provides comprehensive, clinical knowledge to professionals dealing with thyroid disorders. The book focuses on the pathophysiology of thyroid disorders, the prevalence and incidence of various diseases, and their prevention. This focused analysis on thyroid disorders raises awareness of this global problem that, once diagnosed or misdiagnosed, can sometimes lead to over-treatment and cardiovascular complications, especially in the elderly. This succinct, targeted reference gives the reader excellent information on the epidemiology of global thyroid disorders, as well as up-to-date treatment data and a special focus on prevention.

Although the spatial dimension of ecosystem dynamics is now widely recognized, the specific mechanisms behind species patterning in space are still poorly understood and the corresponding theoretical framework is underdeveloped. Going beyond the classical Turing scenario of pattern formation, Spatiotemporal Patterns in Ecology and Epidemiology: Theory, Models, and Simulation illustrates how mathematical modeling and numerical simulations can lead to greater understanding of these issues. It takes a unified approach to population dynamics and epidemiology by presenting several ecoepidemiological models where both the basic interspecies interactions of population dynamics and the impact of an infectious disease are explicitly considered. The book first describes relevant phenomena in ecology and epidemiology, provides examples of pattern formation in natural systems, and summarizes existing modeling approaches. The authors then explore nonspatial models of population dynamics and epidemiology. They present the main scenarios of spatial and spatiotemporal pattern formation in deterministic models of population dynamics. The book also addresses the interaction between deterministic and stochastic processes in ecosystem and epidemic dynamics, discusses the corresponding modeling approaches, and examines how noise and stochasticity affect pattern formation. Reviewing the significant progress made in understanding spatiotemporal patterning in ecological and epidemiological systems, this resource shows that mathematical modeling and numerical simulations are effective tools in the study of population ecology and epidemiology.

This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster randomized design, stratified cluster randomized design, stepped-wedge cluster randomized design, longitudinal cluster randomized design, and crossover cluster randomized design. It demonstrates that the GEE approach is flexible to accommodate pragmatic issues such as hierarchical correlation structures, different missing data patterns, randomly varying cluster sizes, etc. It has been reported that the GEE approach leads to under-estimated variance with limited numbers of clusters. The remedy for this limitation is investigated for the design of PCTs. This book can assist practitioners in the design of PCTs by providing a description of the advantages and disadvantages of various PCTs and sample size formulas that address various pragmatic issues, facilitating the proper implementation of PCTs to improve health care. It can also serve as a textbook for biostatistics students at the graduate level to enhance their knowledge or skill in clinical trial design. Key Features: Discuss the advantages and disadvantages of each type of PCTs, and provide sample size formulas, sensitivity analyses, and examples. Address an unmet need for guidance books on sample size calculations for PCTs; A wide variety of experimental designs adopted by PCTs are covered; The sample size solutions can be readily implemented due to the accommodation of common pragmatic issues encountered in real-world practice; Useful to both academic and industrial biostatisticians involved in clinical trial design; Can be used as a textbook for graduate students majoring in statistics and biostatistics.

Focusses on prospective scenarios in health to foresight possible futures Addresses the urgent needs of the key population, socio-technical, and health themes Covers health innovative practices as 3D models for surgeries, big data to treat rare diseases, AI robot for heart treatments Explores telemedicine using big data, deep learning, robotics, mobile and remote applications Reviews public health based on predictive analytics and disease trends

This stimulating book has become a go-to text for understanding the role that social factors play in the experience of health and many diseases. This extensively revised and updated third edition offers the most compelling case yet that stress, poverty, unhealthy lifestyles, and unpleasant living and working conditions can all be directly associated with illness. The book continues to build on the paradigm shift that has been emerging in twenty-first-century medical sociology, which looks beyond individual explanations for health and disease. As the field has headed toward a fundamentally different orientation, William Cockerham's work has been at the forefront of these changes, and he here marshals evidence and theory for those seeking a clear and authoritative guide to the realities of the social determinants of health. Of particular note in the latest edition is new material on the relationship between gender and health, implications of the life course for health behavior, the health effects of social capital, and the emergence of COVID-19. This engaging introduction to social epidemiology will be indispensable reading for all students and scholars of medical sociology, especially those with the courage to confront the possibility that society really does make people sick.

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.

Cancer is diagnosed in about 140 per million children in Britain each year. There is a 1 in 500 chance that a child will be affected in the first 15 years of life, the most frequently occurring types of cancer being leukaemia and brain tumours. This book covers the descriptive epidemiology of childhood cancer in Britain, based on the unique work of the National Registry of Childhood Tumours, the largest population-based specialist childhood cancer registry in the world. The book provides a detailed account of national incidence and survival rates for childhood cancer in Britain during 1991-2000, and trends during 1966-2000. There is also an account of childhood mortality for the period 1965-2004. The diagnoses are classified throughout according to the International Classification of Childhood Cancer, the first time the third edition of this standard classification has been used for prevalence of incidence, survival and mortality data. The chapter on incidence rates is relevant to planning of health service provision and design of research studies on aetiology, whilst the chapter on trends in incidence is relevant to the possible effects of changes in environmental and other risk factors. In addition to comprehensive tables of rates, age-incidence graphs are provided for all the major types of childhood cancer, and possible artefacts are also discussed. The survival data demonstrates how clinical progress over the past 40 years has led to a major increase in the number of cancer survivors. The role of the Registry, covering history, methodology, current and future uses, is also discussed. This definitive work is the culmination of decades of epidemiological research and is essential reading for anyone involved in paediatric oncology or cancer epidemiology.

This book examines the HIV/AIDS epidemic in the United States using the concept of syndemics to contextualize the risk of both well-known, and a few lesser-known, subpopulations that experience disproportionately high rates of HIV and/or AIDS within the United States. Since discovery, HIV/AIDS has exposed a number of social, psychological, and biological aspects of disease transmission. The concept of "syndemics," or "synergistically interacting epidemics" has emerged as a powerful framework for understanding both the epidemiological patterns and the myriad of problems associated with HIV/AIDS around the world and within the United States. The book considers the disparities in HIV/AIDS in relation to social aspects, risk behavior and critical illness comorbidities. It updates and enhances our understanding of the HIV/AIDS epidemic in the United States and contributes to the expanding literature on the role of syndemics in shaping the public's health.

In Dark Winter, world-leading epidemiologist Professor Raina MacIntyre navigates the past, present and future of pandemics and biosecurity. MacIntyre examines the history of biological warfare (and why it is called the 'poor man's nuke'), Soviet and US bioweapons programmes, developments in genetic engineering, synthetic biology and catastrophic laboratory accidents. She also explores the COVID-19 pandemic and the heated debate around its origins, and shares the analysis she has conducted in trying to determine whether it's a natural or unnatural pandemic. Looking ahead, MacIntyre outlines the future of genetic engineering, synthetic biology and bioterrorism, and the national and global security needed to manage quantum changes in technology, along with how we might avoid future pandemics.

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.

Today's healthcare organizations must focus on a lot more than just the health of their clients. The infrastructure it takes to support clinical-care delivery continues to expand, with information technology being one of the most significant contributors to that growth. As companies have become more dependent on technology for their clinical, administrative, and financial functions, their IT departments and expenditures have had to scale quickly to keep up. However, as technology demands have increased, so have the options for reliable infrastructure for IT applications and data storage. The one that has taken center stage over the past few years is cloud computing. Healthcare researchers are moving their efforts to the cloud because they need adequate resources to process, store, exchange, and use large quantities of medical data. Cloud Computing in Medical Imaging covers the state-of-the-art techniques for cloud computing in medical imaging, healthcare technologies, and services. The book focuses on Machine-learning algorithms for health data security Fog computing in IoT-based health care Medical imaging and healthcare applications using fog IoT networks Diagnostic imaging and associated services Image steganography for medical informatics This book aims to help advance scientific research within the broad field of cloud computing in medical imaging, healthcare technologies, and services. It focuses on major trends and challenges in this area and presents work aimed to identify new techniques and their use in biomedical analysis.

This book is meant for adoption in first courses on epidemiology in Medical Schools and Faculties of Public Health in "developing" and "transition" countries and in workshops in these countries, taught for example by members of international organizations. It is also suitable for parallel or second reading within curricula in "developed" countries and for teaching epidemiology in a Master's programme on "International Health." The book will enable any lecturer to compose his or her introductory courses on epidemiology by selecting the material deemed appropriate. It will provide a solid foundation for more advanced teaching.

The intended readership consists in the first place of general medical students; students following the programme "Preventive Physician" that runs parallel to general medical studies in some countries; students starting to specialize in Public Health; and lecturers in epidemiology. The book can also serve well as an introduction into epidemiology for anybody else interested in this field, for example staff of health institutions.

Examples and practical work are taken from the present situation of health in Vietnam, which can easily be adapted to any other developing or transition country.

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.

"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.

Basic Biostatistics for Medical and Biomedical Practitioners, Second Edition makes it easier to plan experiments, with an emphasis on sample size. It also shows what choices are available when simple tests are unsuitable and offers investigators an overview of how the kinds of complex tests that they won't do on their own work. The second edition presents a new, revised and enhanced version of the chapters, taking into consideration new developments and tools available, discussing topics, such as the basic aspects of statistics, continuous distributions, hypothesis testing, discrete distributions, probability in epidemiology and medical diagnosis, comparing means, regression and correlation. This book is a valuable source for students and researchers looking to expand or refresh their understanding of statistics as it applies to the biomedical and research fields. Based on the author's 40+ years of teaching statistics to medical fellows and biomedical researchers across a wide range of fields, it is a valuable source for researchers who need to understand more about biostatistics to apply it to their work.

Reproducibility in Biomedical Research: Epistemological and Statistical Problems explores the ideas and conundrums inherent in scientific research. It explores factors of reproducibility, including logic, distinguishing productive from unproductive irreproducibility, the scientific method, and the use of statistics. In multiple examples and six detailed case studies, the book demonstrates the misuse of logic resulting in unproductive irreproducibility, allowing researchers to develop their own logic and planning abilities. Biomedical researchers, clinicians, administrators of scientific institutions and funding agencies, journal editors, philosophers of science and medicine will find the arguments and explorations a valuable addition to their libraries.

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

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.

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.