Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focused on the practical aspects of SOPs and SOP management. The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example "SOP of SOPs" along with an associated SOP template.

"Explains why a significant body of scientific research has been largely ignored by cancer research institutions. Hess has clearly demonstrated the valuable role that social scientists can have in offering a neutral perspective on medical research and how it is shaped by cultural bias."
--"Townsend Letter"

"Hess has made a careful study of one of the most intriguing themes that weaves through the recent history of unconventional approaches to cancer. Every researcher, physician, and general reader interested in this field should welcome this important and incisive contribution."
--"Michael Lerner
President, Commonweal, and author of "Choices in Healing"

Growing numbers of cancer patients are exploring diet, food supplements, herbs, and nontoxic immunotherapies like bacterial vaccines as a means of therapy. Yet most cancer research organizations refuse to even evaluate these alternatives. "Can Bacteria Cause Cancer?" argues convincingly that unless this neglected world of alternative therapies is properly scrutinized, the medical Vietnam of the twentieth century may well affect one in two people by the twenty-first century.

David J. Hess investigates one of the great medical mysteries of the twentieth century--the relationship between bacteria and chronic disease. Recently scientists have overturned long-held beliefs by demonstrating that bacterial infections cause many ulcers; they are now reconsidering the role of bacterial infections in other chronic diseases, such as arthritis. Is it possible, Hess asks, that bacteria can contribute to the many other known causes of cancer?

To answer this intriguing question, Hess takes us into the world of alternative cancerresearchers. Maintaining that their work has been actively suppressed rather than simply dismissed, he examines their claims---that bacterial vaccines have led to some dramatic cases of long-term cancer remission--and the scientific potential of their theories. Economic interests and cultural values, he demonstrates, have influenced the rush toward radiation and chemotherapy and the current cul-de-sac of toxic treatments.

More than a medical mystery story, "Can Bacteria Cause Cancer?" is a dramatic case study of the failure of the war on cancer.

Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine.

"Integrative Approaches for Health: Biomedical Research, Ayurveda and Yoga" brings together interdisciplinary and integrative approaches to health and medicine in one comprehensive reference. It covers the concept of Evidence Based Medicine (EBM) as a common thread to connect medical systems, facilitating dialogue and triggering the evolution of Integrative Medicine. The basic principles of Ayurveda and Yoga are connected and juxtaposed to the modern systems biology including the complex relationships between cells, tissues, organs and body to get better and inclusive picture of Integrative Medicine. This book introduces readers the potentials of Ayurveda and Yoga as important components of Integrative Medicine as also knowledge sources for future research in biomedicine.
Contains a confluence of ancient and modern concepts, historical perspectives, philosophical underpinnings and an extensive review of literature supported by worldwide case studies. Provides a contemporary analysis of ancient wisdom, pointing to potential areas for future research, allowing for contemplation of forthcoming healthcare and integrative medicine practices.Offers illustrative charts, timelines and entity relationship logic diagrams for enhanced understanding of concepts presented.Shows Ayurveda knowledge and its relevance to drug discovery, personalized medicine, genomics, epigenomics, regenerative medicine, longevity, and nanotechnology.Shares yoga knowledge insights and explains its relevance to body -mind complex relationships, psycho-neuro-immuno-endocrinology, bioenergetics, consciousness, and cognitive sciences.

Patient organizations and social health movements offer one of the most important and illuminating examples of civil society engagement and participation in scientific research and research politics. Influencing the research agenda, and initiating, funding and accelerating the development of diagnostic tools, effective therapies and appropriate health-care for their area of interest, they may champion alternative, sometimes controversial, programs or critique dominant medical paradigms. Some movements and organizations advocate for medical recognition of contested illnesses, as with fibromyalgia orADHD, while some attempt to "de-medicalize" others, such as obesity or autism. Bringing together an international selection of leading scholars and representatives from patients' organizations, this comprehensive collection explores the interaction between civil society groups and biomedical science, technology development, and research politics. It takes stock of the key findings of the research conducted in the field over the past two decades and addresses emerging problems and future challenges concerning the interrelations between health movements and patient organisations on the one hand, and biomedical research and research policies on the other hand. Combining empirical case studies with conceptual discussion, the book discusses how public participation can contribute to, as well as restrict, the democratization of scientific knowledge production. This volume is an important reference for academics and researchers with an interest in the sociology of health and illness, science and technology studies, the sociology of knowledge, medical ethics or healthcare management and research, as well as medical researchers and those involved with health-related civil society organizations.

A complete guide to understanding cluster randomised trials Written by two researchers with extensive experience in the field, this book presents a complete guide to the design, analysis and reporting of cluster randomised trials. It spans a wide range of applications: trials in developing countries, trials in primary care, trials in the health services. A key feature is the use of R code and code from other popular packages to plan and analyse cluster trials, using data from actual trials. The book contains clear technical descriptions of the models used, and considers in detail the ethics involved in such trials and the problems in planning them. For readers and students who do not intend to run a trial but wish to be a critical reader of the literature, there are sections on the CONSORT statement, and exercises in reading published trials. * Written in a clear, accessible style * Features real examples taken from the authors extensive practitioner experience of designing and analysing clinical trials * Demonstrates the use of R, Stata and SPSS for statistical analysis * Includes computer code so the reader can replicate all the analyses * Discusses neglected areas such as ethics and practical issues in running cluster randomised trials How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research provides an excellent reference tool and can be read with profit by statisticians, health services researchers, systematic reviewers and critical readers of cluster randomised trials.

How to identify optimal phase II trial designs Providing a practical guide containing the information needed to make crucial decisions regarding phase II trial designs, A Practical Guide to Designing Phase II Trials in Oncology sets forth specific points for consideration between the statistician and clinician when designing a phase II trial, including issues such as how the treatment works, choice of outcome measure and randomization, and considering both academic and industry perspectives. A comprehensive and systematic library of available phase II trial designs is included, saving time otherwise spent considering multiple manuscripts, and real-life practical examples of using this approach to design phase II trials in cancer are given. A Practical Guide to Designing Phase II Trials in Oncology: * Offers a structured and practical approach to phase II trial design. * Considers trial design from both an academic and industry perspective. * Includes a structured library of available phase II trial designs. * Is relevant to both clinical and statistical researchers at all levels * Includes real life examples of applying this approach. * For those new to trial design, A Practical Guide to Designing Phase II Trials in Oncology will be a unique and practical learning tool, providing an introduction to the concepts behind informed decision making in phase II trials. For more experienced practitioners, the book will offer an overview of new, less familiar approaches to phase II trial design, providing alternative options to those which they may have previously used.

The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. However, despite these advances, no book has served as a single source of information for statistical methods in drug combination research, nor has there been any guidance for experimental strategies. Statistical Methods in Drug Combination Studies fills that gap, covering all aspects of drug combination research, from designing in vitro drug combination studies to analyzing clinical trial data. Featuring contributions from researchers in industry, academia, and regulatory agencies, this comprehensive reference: Describes statistical models used to characterize dose-response patterns of monotherapies and evaluate the combination drug synergy Offers guidance for estimating interaction indices and constructing their associated confidence intervals to assess drug interaction Introduces a practical and innovative Bayesian approach to Phase I cancer trials, including actual trial examples to illustrate use Examines strategies in the fixed-dose combination therapy clinical development via case studies stemming from regulatory reviews Evaluates computational tools and software packages used to apply novel statistical methods in combination drug development Statistical Methods in Drug Combination Studies provides researchers with a solid understanding of the available statistical methods and computational tools and how to apply them in drug combination studies. The book is equally useful for statisticians to become better equipped to deal with drug combination study design and analysis in their practice.

Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement. Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.

Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments. Such trials are widely used in clinical and medical research, and in other diverse areas such as veterinary science, psychology, sports science, and agriculture. The first edition of this book was the first to be wholly devoted to the subject. The second edition was revised to mirror growth and development in areas where the design remained in widespread use and new areas where it had grown in importance. This new Third Edition: Contains seven new chapters written in the form of short case studies that address re-estimating sample size when testing for average bioequivalence, fitting a nonlinear dose response function, estimating a dose to take forward from phase two to phase three, establishing proof of concept, and recalculating the sample size using conditional power Employs the R package Crossover, specially created to accompany the book and provide a graphical user interface for locating designs in a large catalog and for searching for new designs Includes updates regarding the use of period baselines and the analysis of data from very small trials Reflects the availability of new procedures in SAS, particularly proc glimmix Presents the SAS procedure proc mcmc as an alternative to WinBUGS for Bayesian analysis Complete with real data and downloadable SAS code, Design and Analysis of Cross-Over Trials, Third Edition provides a practical understanding of the latest methods along with the necessary tools for implementation.

This volume looks at major clinical trials for motor and non-motor symptoms in Parkinson's Disease (PD) and covers important aspects, including trial design, sample selection, and outcome selection. Chapters in this book discuss topics such as toxin-based rodent or genetic models of PD; clinical trials for motor symptoms, L-DOPA related motor complications, and gait disorders; clinical trials for mood disorders, troubled sleep, autonomic dysfunction; and clinical trials for disease modifying therapies. In the Neuromethods series style, chapters include the kind of detail and key advice from the specialists needed to get successful results in your laboratory or research center. Cutting-edge and authoritative, Clinical Trials in Parkinson's Disease is a valuable resource for clinicians and researchers who want to enhance their interpretation of results from clinical trials and to design their own high-quality trials.

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.

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.

This is the only book to offer an evidence-based model for retaining students and ensuring success across the nursing education spectrum. It is designed to assist faculty in creating, implementing, and evaluating student retention and academic success strategies. This model, Nursing Undergraduate Retention and Success (NURS), can be used effectively with all kinds of nursing programs, both traditional and nontraditional, including diploma, ADN, RN-BS, and accelerated BS.

The book features the "Nursing Student Retention Toolkit," an easy-to-use digital toolkit for assessment and planning that is thoroughly cross-referenced and integrated into the text. Together, these complementary resources offer a wide selection of educational activities and support strategies for diverse learners and settings. The text provides guidelines for maximizing educational strengths, identifying and assessing at-risk students, facilitating student retention, and revitalizing teaching methods. It examines the multidimensional factors that must be considered, including cultural values and beliefs, and describes proven strategies for promoting retention and academic success such as faculty advisement, promoting professional events and membership, peer partnerships, and enrichment programs. "Nursing Student Retention," with its breadth of information and one-of-a-kind digital toolkit, will be of great value to nurse educators, administrators, and graduate students. This new edition features:

An easy-to-use format that includes the "Nursing Student Retention Toolkit, "a digital adjunct containing assessment tools, and templates for designing, implementing, and evaluating retention strategies Chapters updated to provide a wealth of new information and evidence-based strategies Real-life scenarios featuring diverse learners and settings Vignettes to synthesize and demonstrate application of learning

Defines best practices for leveraging of discovery research to facilitate a science-based, rational, and predictive preclinical development program to ensure clinical efficacy and safety Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications

Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I-II Clinical Trials describes how phase I-II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.

"Neural Crest Cells: Evolution, Development and Disease" summarizes discoveries of historical significance and provides in-depth, current analyses of the evolution of neural crest cells, their contribution to embryo development, and their roles in disease. In addition, prospects for tissue engineering, repair and regeneration are covered, offering a timely synthesis of the current knowledge in neural crest cell research. A comprehensive resource on neural crest cells for researchers studying cell biology, developmental biology, stem cells and neurobiology, "Neural Crest Cells: Evolution, Development and Disease "provides foundational information needed for students, practicing physicians and dentists treating patients with craniofacial defects.
Provides timely, comprehensive synthesis of the current knowledge of neural crest cellsCovers the evolution and development of neural crest cellsIncludes content on applications for tissue engineering, repair and regeneration

This new edition explores and provides an update on the biology and pathogenesis of human cytomegalovirus infection. Modern techniques that are currently being utilized to investigate the molecular aspects of viral infection, as well as how these new research studies are leading to new approaches to mitigate disease, are also provided. Given the key role the virus plays in significant acute and chronic human disease in all stages of life, from newborns to seniors, the need for clear methodologies to further explore the biology of HCMV infection and mitigation strategies is readily apparent. Written in the highly successful Methods in Molecular Biology format, 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, Human Cytomegaloviruses: Methods and Protocols, Second Edition serves as an ideal scientific reference for basic and clinical scientists and medical personnel on the modern understanding of the pathobiology of the virus, and the approaches, techniques, and models to study human cytomegalovirus infection and disease.

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.

"Advances in Cancer Research" provides invaluable information on the exciting and fast-moving field of cancer research. Here, once again, outstanding and original reviews are presented on a variety of topics.
Provides information on cancer research

Oustanding and original reviews

Suitable for researchers and students

This collection provides detailed information on current advances in analytical methods and strategies employed for monitoring and discovering a wide range of novel psychoactive substances (NPS) in clinical and forensic laboratories. The main classes of NPS in terms of prevalence include synthetic cannabinoids, synthetic cathinones, synthetic opioids, and designer or synthetic benzodiazepines, and this book explores selecting the appropriate sample matrix and analytical testing approaches for laboratories faced with NPS drug testing, such as in blood, urine, saliva, and hair. Written for the Methods in Pharmacology and Toxicology series, chapters in this volume feature the kind of detailed implementation advice from the experts that leads to successful results in the lab. Authoritative and practical, Methods for Novel Psychoactive Substance Analysis serves as an ideal guide for forensic and clinical toxicologists, pharmacologists and chemists in academic and research settings, as well as for private laboratories seeking to increase our ability to test for these substances. @font-face {font-family:"Cambria Math"; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-pitch:variable; mso-font-signature:-536869121 1107305727 33554432 0 415 0;}@font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-469750017 -1073732485 9 0 511 0;}p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0cm; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:11.0pt; font-family:"Times New Roman",serif; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}.MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; mso-bidi-font-size:11.0pt; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}div.WordSection1 {page:WordSection1;}

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.

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.