Today, when many parents seem reluctant to have their children vaccinated, even with long proven medications, the Salk vaccine trial, which enrolled millions of healthy children to test an unproven medical intervention, seems nothing short of astonishing. In Selling Science, medical historian Stephen E. Mawdsley recounts the untold story of the first large clinical trial to control polio using healthy children - 55,000 healthy children - revealing how this long-forgotten incident cleared the path for Salk's later trial. Mawdsley describes how, in the early 1950s, Dr. William Hammon and the National Foundation for Infantile Paralysis launched a pioneering medical experiment on a previously untried scale. Conducted on over 55,000 healthy children in Texas, Utah, Iowa, and Nebraska, this landmark study assessed the safety and effectiveness of a blood component, gamma globulin, to prevent paralytic polio. The value of the proposed experiment was questioned by many prominent health professionals as it harbored potential health risks, but as Mawdsley points out, compromise and coercion moved it forward. And though the trial returned dubious results, it was presented to the public as a triumph and used to justify a federally sanctioned mass immunization study on thousands of families between 1953 and 1954. Indeed, the concept, conduct, and outcome of the GG study were sold to health professionals, medical researchers, and the public at each stage. At a time when most Americans trusted scientists, their mutual encounter under the auspices of conquering disease was shaped by politics, marketing, and at times, deception. Drawing on oral history interviews, medical journals, newspapers, meeting minutes, and private institutional records, Selling Science sheds light on the ethics of scientific conduct, and on the power of marketing to shape public opinion about medical experimentation.

Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." - Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women's health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

This book is all about the definition and finding ways to prioritize and accelerate translation research in biomedical sciences and rapidly turning new knowledge into first-in-human studies. It represents an effort to bring together scientists active in various areas of translational research to share science and, hopefully, generate new ideas and potential collaborations. The book provides a comprehensive overview of translational work that includes significant discoveries and pioneering contributions, e.g., in immunology, gene therapy, stem cells and population sciences. It may be used as an advanced textbook by graduate students and even ambitious undergraduates in biomedical sciences. It is also suitable for non-experts, i.e. medical doctors, who wish to have an overview of some of the fundamental models in translational research.Managing the translational enterprise remains a work in progress. The world is changing rapidly, and the scientific world needs to seek new ways to ensure that discoveries get translated for patients efficiently and as quickly as possible. In addition, everyone expects the investment in biomedical research should pay dividends through effective therapeutic solutions. This unique project provides a broad collaborative approach of the international scientific team to present its view and opinion how to cross barriers to incentives for translational research in medical sciences.Contributing to the book is an international team of prominent co-authors. The book consists of unique and widely treated topics, and includes new hypotheses, data and analyses.

The four sections of this book cover cell and molecular biology of tumor metabolism, metabolites, tumor microenvironment, diagnostics and epigenetics. Written by international experts, it provides a thorough insight into and understanding of tumor cell metabolism and its role in tumor biology. The book is intended for scientists in cancer cell and molecular biology, scientists in drug and diagnostic development, as well as for clinicians and oncologists.

The detailed volume aims to provide a comprehensive hands-on manual covering all the techniques involved in the cellular and molecular identification and characterization of both normal hematopoietic and leukemic stem cells, both from human patients and from mouse models of human leukemia. The book also covers the most frequently used experimental approaches for the generation of such stem cell-based models of human leukemia. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and comprehensive, Leukemia Stem Cells: Methods and Protocols serves as an ideal guide for researchers, both expert and novice, seeking to further our knowledge of this vital avenue of cancer research.

With the advances of medicine, questions of medical ethics have become more urgent and are now considered of great social and political significance. An innovatively designed, activity-based workbook, this text was prepared using papers and case studies collected from several countries in the European Union. It reflects the issues and concerns that confront clinical practitioners throughout Europe and elsewhere today and presents varying national responses in law and policy to these concerns, as identified by ethicists, lawyers, theologians and practitioners. The problems they examine include the relationship between medical research and medical practice, elementary regulations of medical research, the complexity of informed consent, and the role of the sponsor or scientific community.

Nanomedicine consists of the use of nanotechnology and nanobiotechnology in medicine. There have been extensive developments in the area of nanomedicine. The scope of this book is first to discuss the origin of nanomedicine. Following this, instead of a general overview of the whole area, 24 chapters on selected topics of important areas are described in detail. Authors are selected from around the world to give a representative and international view of the activities in the area of nanomedicine.

Respiration is an area of the medical study that undergoes fast developments. A better understanding of the neural and cellular mechanisms underlying respiratory disorders and lung function is essential for the evidence-based pharmacotherapy and for optimizing the patient care and prophylactic measures to improve the health and quality of life. This comprehensive book is a blend of basic and clinical research. The book is thought to promote the translation of science into clinical practice. The book presents an update on the areas of current research and clinical interest in the neurobiology of the respiratory system. Recent innovations in detection and management of respiratory diseases are described. The book will be a base of reference in the field of respiration for years to come and a source of future research ideas. This book is a required text for respiratory scientists, neuropathologists, and for clinicians searching for 'bench to bedside' treatments of lung diseases.

Because of the huge potential of human embryonic stem (hES) cells, especially the newly developed human induced pluripotent stem (hiPS) cells, in disease treatment and life quality improvement, enormous efforts have been made to develop new methodologies to translate lab discoveries in stem cell research into bed-side clinical technologies. In Human Embryonic and Induced Pluripotent Stem Cells: Lineage-Specific Differentiation Protocols, experts in the field present a comprehensive collection of protocols designed for labs around the world. The topics covered in this detailed volume include techniques used for maintenance of hES and iPS cells in either small or large scale, techniques for directing hES and iPS cell lineage specification, techniques for enhancing the maturity of differentiated hES and iPS cells within three-dimensional scaffolds, techniques for reprogramming adult cells into iPS cells, techniques for generating patient-specific iPS cells, and techniques for translating hES and iPS cell research into new therapies. Chapters include lab ready protocols with tips on troubleshooting and avoiding known pitfalls. Wide-ranging and authoritative, Human Embryonic and Induced Pluripotent Stem Cells: Lineage-Specific Differentiation Protocols will be a tremendous aid for researchers and students who wish to explore these areas and transform their discoveries into the next generation of regenerative medicine and tissue engineering technologies.

This book summarizes the state-of-the art in the development of T cell-based "in vitro" assays, which offer useful tools for hazard identification, risk assessment and improvement of diagnostics. It will be of interest to scientists, the chemical and pharmaceutical industry, and regulators involved in the replacement of animal testing methods.

The identification of hazardous chemicals and drugs is essential to ensuring human health. The ban on animal testing for the cosmetics industry since 2009 and international efforts to reduce and replace animal testing in research and immunotoxicology call for alternative "in vitro" methods. The most specific immune response to chemicals and drugs that cause allergic contact dermatitis, respiratory disease and adverse drug reactions is the highly antigen-specific T lymphocyte response. Therefore the use of T cells as tools for identifying contact allergens and drugs that may cause health problems is of great interest.

Lead by both children's rights perspectives and methodological arguments there is an increasing emphasis on children and young people's participation in health and social care research by researchers, policy makers and funding bodies - with many now considering the active involvement of children and young people a requirement. However, although increasingly important, there is little exploration of how to address and overcome the many challenges arising from their participation. Divided into five parts, this practical book begins by considering what research with young people is and why we should do it, before leading the reader into how to undertake it. The book then provides practical examples of action and finishes with reflections about the whole process. Bringing together a variety of experienced researchers, from a wide range of backgrounds in health and social care and including young people, the chapters provide insight for practical action, as well as critical and theoretical reflection. Involving Children and Young People in Health and Social Care Research includes issues on: Understanding the reasons and processes for involving children and young people in research Making sure that involvement is meaningful and not merely tokenistic Developing research methods that are commensurate with different ages and abilities Ensuring adequate training and preparation, for children, young people and adults to make involvement meaningful Power and relationships between young people researchers and adult researchers Sustaining young people's interest and motivation Addressing ethical issues that arise throughout the research journey Committed to partnership and participation throughout the entire process of the active involvement of children and young people in health and social care research, this text provides invaluable insights and is a resource for all those conducting research in and with children and young people.

Fluorescence Molecular Tomography: Principles and Applications is the first book to cover the underlying principles and practical applications of fluorescence molecular tomography (FMT) in a systematic manner. Using a tutorial approach, the text begins with an overview of the fundamentals of FMT and goes on to detail image reconstruction approaches (including linear and nonlinear reconstruction algorithms), FMT instrumentations (including time-domain, frequency-domain, and continuous-wave domain systems), and implementation of image-enhancing schemes (including both software and hardware approaches). Further chapters examine multimodal approaches combining photoacoustic tomography (PAT), computed tomography (CT), single-photon emission tomography (SPECT), and magnetic resonance imaging (MRI) and discuss bioluminescence tomography and miniaturized FMT from hand-held to endoscopic FMT. A final chapter looks at clinical applications and animal studies. This authoritative and practical guide will serve as a valuable reference for researchers, scientists, clinicians, and industry professionals. The first book dedicated to fluorescence molecular tomography (FMT); Covers underlying principles and practical applications; Written by a leading FMT research pioneer and expert.

The study of human reproduction has focused on reproductive 'success' and on the struggle to achieve this, rather than on the much more common experience of 'failure', or reproductive loss. Drawing on the latest research from The UK and Europe, The United States, Australia and Africa, this volume examines the experience of reproductive loss in its widest sense to include termination of pregnancy, miscarriage, stillbirth, perinatal and infant death, as well as - more broadly - the loss of desired normative experiences such as that associated with infertility, assisted reproduction and the medicalisation of 'high risk' pregnancy and birth. Exploring the commonalities, as well as issues of difference and diversity, Understanding Reproductive Loss presents international work from a variety of multi-disciplinary perspectives and will appeal to sociologists, anthropologists and other social scientists with interests in medicine, health, the body, death studies and gender.

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

The knowledge base in the domains of quality of life, well-being, and subjective well-being is continuing to grow at a rapid rate. In light of this growth, and the interest it reflects on the part of scholars, practitioners, and policy makers internationally, this book will play an important role in bringing scholars and students up to date on diverse topics and promoting and encouraging research in the field of quality-of-life (QOL) studies. Unlike most other similar publications quality of life studies is broadly construed to involve all of the social and health sciences. This volume has much to offer the reader. The papers reflect a diversity of disciplinary and methodological perspectives, it contains material on (a) the monitoring, assessing, and modelling of quality of life, (b) matters of policy, finance, marketing, and business, and (c) papers devoted to the determinants and correlates of well-being and quality of life.

"Community-Based Participatory Research (CBPR) has become the preferred model for conducting research in communities. Most scientists who conduct such research now recognize that working in partnership with the community is preferable, and more ethical, than conducting research on a community . As Surgeon General of the United States, I direct a number of programs aimed at encouraging Americans to avoid tobacco, engage in physical activity, consume more nutritious diets, and protect their health in other ways. We need more effective methods to persuade, motivate, and enable individuals and communities to adopt these healthier lifestyles, and it is through CBPR that we will be able to discover these methods." From the Foreword by Regina M. Benjamin, MD, MBA, U.S. Surgeon General

"The editors of this book bring together in one place both a description of epidemiological methods and a discussion of community-level issues. It is a volume that will prove useful to those who wish to conduct contemporary community-based research." - Praise for the First Edition from the Foreword David Satcher, Former Surgeon General of the United States

This second edition of a highly regarded textbook on the foundations of and strategies for achieving fertile community-based health care research has been completely revised and updated. It now includes new chapters on translating research into practice, evaluating research, and applying community-based participatory research (CBPR) principles to service, education, and evaluation. The book also updates a crucial chapter on the voices of community stakeholders and an important study of the ethical issues surrounding the Tuskegee Syphilis Study. Edited by renowned professors of community-based research, the text is distinguished by its how-to approach and focus on practical research methods.

The text discusses the unique challenges of conducting CBPR and addresses ways to build and sustain community partnerships. It explores ethical issues regarding health care research, includes input from community stakeholders, and describes national and international support for CBPR. Research methods covered include qualitative studies, surveys, and intervention trials. Applications of CBPR illustrate how to translate research into practice and community-based participatory approaches to service, education, and evaluation. The second edition includes new chapters on:

Building and sustaining researcher/community partnerships National and international investments in and support for CBPR Surveys and methods for conducting CBPR Translating research into practice Community-based participatory approaches to service, education, and evaluation

An unprecedented compilation of state-of-the-art advances in clinical research on diabetes and obesity by premier clinical scientists around the world. This volume critically reviews the limitations and strengths of today's major techniques in clinical diabetes research, and then reviews how those methods have been used to carry out cutting-edge studies of carbohydrate, lipid, and protein metabolism in the disease.

This landmark annual review has provided nearly three decades of knowledge, insight, and research on topics critical to nurses everywhere.

The purpose of this annual review is to critically examine the full gamut of literature on key topics in nursing practice, including nursing theory, care delivery, nursing education, and the professional aspects of nursing.

Past volumes of "Annual Review of Nursing Research" have addressed critical issues such as: Chronic illness Geriatrics Alcohol abuse Patient safety Rural nursing Tobacco use Nursing workforce issues Genetics

For the first time ever, we invite readers to purchase either individual issues of this annual review, or to subscribe to the complete periodical and gain access to all previously published and forthcoming issues.

This revised third edition has been updated to cover all aspects of chiral drugs from the academic, governmental industrial and clinical perspective reflecting the many advances in techniques and methodology. The title will cover new material including the use of enzymes for the synthesis and resolution of enantiomeric compounds as well, as their use in drug discovery; how stereochemistry impacts on decisions taken during the ADMET (absorption, distribution, metabolism, excretion, toxicity) stage of drug discovery; issues faced during the final stages of the drug development process; the impact of ICH (International Conference on Harmonisation) on the use of single isomer drugs; racemic switches; and legal perspectives looking at IP and patent issues surrounding chiral switches and marketing single enantiomer switches.

This Third Edition comprehensively presents all aspects of chiral drugs from scientific, academic, governmental, industrial, and clinical points of view. This one-stop text covers the lifespan of stereochemistry, from its early history, including an overview of terms and concepts, to the current drug development process, legal and regulatory issues, and the new stereoisomeric drugs.

New topics include:

• The use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug discovery
• How stereochemistry impacts decisions made in the Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) stages of drug discovery
• A chapter on pharmacokinetics and pharmacodynamics that discusses the issues faced during the final stages of the drug development process
• The impact of International Conference on Harmonisation on the use of single isomer drugs
• Chiral switches
• The concept of molecular chiral recognition and how it affects the separation and behavior of stereochemically pure drugs
• A chapter on the legal perspectives of patent issues surrounding chiral switches and the marketing of single enantiomer switches
• This will be a one-stop shop for pharmaceutical scientists and chemists working with chiral drug molecules
  

The leading figure in qualitative health research (QHR), Janice M. Morse, asserts that QHR is its own separate discipline--distinct from both traditional health research and other kinds of qualitative research--and examines the implications of this position for theory, research, and practice. She contends that the health care environments transform many of the traditional norms of qualitative research and shape a new and different kind of research tradition. Similarly, the humanizing ethos of qualitative health research has much to teach traditional researchers and practitioners in health disciplines. She explores how the discipline of QHR can play out in practice, both in the clinic and in the classroom, in North America and around the world. A challenging, thought-provoking call to rethink how to conduct qualitative research in health settings.

The main focus of this book is on brown adipose tissue and its metabolic function. The book provides a timely update on the latest research and shows where the field is heading. Brown adipose tissue (BAT) dissipates energy and has received considerable attention in the last few years, having been re-discovered in adult humans in 2007/9. Moreover, BAT might offer a target for novel therapies to address obesity, a health condition that has reached pandemic dimensions.

Led by both children s rights perspectives and methodological arguments, there is an increasing emphasis on children and young people s participation in health and social care research by researchers, policy makers and funding bodies with many now considering the active involvement of children and young people a requirement. There is little exploration of how to address and overcome the many challenges arising from their participation, however.

Divided into five parts, this practical book begins by considering what research with young people is and why we should do it, before leading the reader into how to undertake it. The book then provides practical examples of action and finishes with reflections about the whole process. Bringing together a variety of experienced researchers, from a wide range of backgrounds in health and social care and including young people, the chapters provide insight for practical action, as well as critical and theoretical reflection. Involving Children and Young People in Health and Social Care Research includes issues on:

• Understanding the reasons and processes for involving children and young people in research
• Making sure that involvement is meaningful and not merely tokenistic
• Developing research methods that are commensurate with different ages and abilities
• Ensuring adequate training and preparation, for children, young people and adults to make involvement meaningful
• Power and relationships between young people researchers and adult researchers
• Sustaining young people s interest and motivation
• Addressing ethical issues that arise throughout the research journey

Committed to partnership and participation throughout the entire process of the active involvement of children and young people in health and social care research, this text provides invaluable insights and is a resource for all those conducting research in and with children and young people.

One of the first studies of an exciting new development in global biotechnology, this cutting edge text examines the extent of the transnational movements of tissues, stem cells, and expertise, in the developing governance framework of India.

Documenting the impact of local and global governance frames on the everyday conduct of research, this groundbreaking book traces the journey of spare human embryos in IVF clinics to public and private laboratories engaged in isolating stem cells for potential therapeutic application. The discussion also examines the gender dimension as a potential site for exploitation in the sourcing of embryonic and other biogenic materials, and suggests that a moral economy has developed in which the ethical values of the global 'North' support and encourage the donation of abundant and ethically neutral embryos by the 'South'.

This unique exploration is grounded in an empirical, multi-sited ethnographic study that takes a thoroughly comparative analysis of the ethical, religious and social issues in Europe, the United States, and organ donations already prevalent in India. In this theoretically-sensitive analysis, the authors use the resources of social anthropology and the social sciences in an innovative text which will appeal to postgraduates and professionals in the areas of STS studies, genetics, bioethics, and anthropology.

This book is a brief introductory text of the fundamental electrochemistry that is essential for important biomedical areas including electrophysiology, biosensors and even gene technology. The book targets readers who generally lack a substantial background knowledge in physical chemistry or the basic concepts in electricity for understanding most of the electrochemical textbooks, monographs or research articles. The contents are expressed in a concise and concept-by-concept manner with basic material such as math or optional applications appended in the appendices. Hopefully, it will be a quick and efficient solution for those who are eager to understand, handle and even develop an electrochemical method or tool by themselves.Co-publish with National Taiwan University. Distributed worldwide by World Scientific Publishing Co. except Taiwan.

This fully updated edition provides selected mouse genetic techniques and their application in modeling varieties of human diseases. The chapters are mainly focused on the generation of different transgenic mice to accomplish the manipulation of genes of interest, tracing cell lineages, and modeling human diseases. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and up-to-date, Mouse Genetics: Methods and Protocols, Second Edition delivers fundamental techniques and protocols to geneticists, molecular biologists, cell and developmental biologists, students, and postdoctoral fellows working in the various disciplines of genetics, developmental biology, mouse genetics, and modeling human diseases.