The second volume in the Wiley reference series in Biostatistics.

Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in:

• Bayesian methods
  
• Benefit/risk assessment
  
• Cost-effectiveness
  
• Ethics
  
• Fraud

Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials:

• Includes concise definitions and introductions to numerous concepts found in current literature

• Discusses the software and textbooks available

• Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts

This book examines developments in qualitative psychotherapeutic research. It focuses on different methods and aspects of clinical practice. These range from the experiences of service users and clinicians, examining in detail different aspects of how therapy gets done in practice, to critiquing the politics and ideologies of psychotherapy practice. It aims to reflect the diversity that characterises this developing field and to represent practice-based research carried out in different clinical settings, from different perspectives and in different sociocultural contexts. The wide range of research projects presented arise from a network of clinicians and psychotherapy researchers who have established an international transdisciplinary forum for dedicated qualitative research on a range of topics in the field of mental health, using a variety of methodologies and theoretical approaches. In the spirit of dialogue, this book further provides chapters written by key practitioners in the field of qualitative research in mental health discussing these contributions. This book was originally published as a special issue of the European Journal of Psychotherapy & Counselling.

This book presents a state-of-the-art report on recent advances concerning Ganoderma and where the field is going. Although some older work is also cited, the main focus is on advances made over the past 20 years in the pharmacology and clinical applications of Ganoderma. Ganoderma lucidum (Lingzhi) has been used as a traditional medicine in Asian countries to maintain health and to treat diseases for more than two thousand years. Recently, its value has been demonstrated in preventing and treating certain diseases, such as tumors, liver disorders, renal injury, hypercholesterolemia, obesity, cerebral ischemia reperfusion, bronchitis etc. In addition, laboratory and clinical studies have confirmed that the chemical components of Ganoderma, such as Ganoderma lucidum polysaccharide peptides and triterpenes isolated from the fruiting body of Ganoderma lucidum, produce diverse pharmacological effects. Ganoderma and its components play an important part in antioxidant stress, radical-scavenging, immunomodulation, and intracellular signaling regulation, and accordingly warrant further study. This book systematically reviews the latest advances in our understanding of pharmacology and clinical applications of Ganoderma, and offers researchers and graduate students valuable new insights into the pharmacology and clinical applications of Ganoderma and related products.

This open access book is the outcome of a Global Forum on Innovation, Intellectual Property and Access to Medicines held in December 2019 at the Max Plank Instititute in Munich, organised by the South Centre and the Max Plank Institute. The academics and experts from international organisations participating have contributed chapters to this book. The book is for policy makers (in Ministries of Health, Ministries of Trade, Ministries of Foreign Affairs, patent offices), but also relevant for academics (law, trade, public health), on the flexibilities available in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization to promote access to medicines.

Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.

What is research and how does it work in the context of nursing, health and social care? This introductory guide provides you with a concise overview of the different research methods and terminology that you will come across when undertaking research in any course related to nursing, health and social care. The book's easy-to-follow structure takes you from research novice to confident researcher, helping you to make sense of research and understand how it is implemented in healthcare practice. The new edition includes: Updates in light of the 2018 NMC standards, with more information on the impact of GDPR, consent and vulnerable groups, Personal and Public Involvement (PPI), and work-based projects. Improved case examples of real research, with more on group work, poster presentations, research output and dissemination, literature reviews, and dissertations. Upgraded activities that include reflective exercises, critical appraisal tools, a dissemination plan, and a glossary, all in the book. This is essential reading for undergraduate and postgraduate students within the health and therapy professions, nurses, midwives, physiotherapists, radiographers, occupational therapists, speech and language therapists, and paramedics.

While regression models have become standard tools in medical research, understanding how to properly apply the models and interpret the results is often challenging for beginners. Regression Models as a Tool in Medical Research presents the fundamental concepts and important aspects of regression models most commonly used in medical research, including the classical regression model for continuous outcomes, the logistic regression model for binary outcomes, and the Cox proportional hazards model for survival data. The text emphasizes adequate use, correct interpretation of results, appropriate presentation of results, and avoidance of potential pitfalls. After reviewing popular models and basic methods, the book focuses on advanced topics and techniques. It considers the comparison of regression coefficients, the selection of covariates, the modeling of nonlinear and nonadditive effects, and the analysis of clustered and longitudinal data, highlighting the impact of selection mechanisms, measurement error, and incomplete covariate data. The text then covers the use of regression models to construct risk scores and predictors. It also gives an overview of more specific regression models and their applications as well as alternatives to regression modeling. The mathematical details underlying the estimation and inference techniques are provided in the appendices.

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Presents health benefits and medicinal importance of dietary polyphenols having antioxidative effects and their possible preventive role against oxidative stress (OS)-induced chronic human diseases Summarizes latest understanding on the biochemical mechanism(s) involved in the antioxidative action of dietary polyphenols along with their bioavailability, pharmacokinetic, and toxicological considerations Highlights novel approaches of drug discovery from dietary polyphenols through computational screening of bioactive phytochemical components

Scientists working or planning to work in the field of cardiovascular research will welcome Practical Methods in Cardiovascular Research as the reference book they have long been waiting for. Not only general aspects of cardiovascular research are well presented, but also detailed descriptions of methods and protocols and practical examples. Written by leading scientists in their field, chapters cover classical methods such as the Langendorff heart or working heart models as well as numerous new techniques and methods. Newcomers and experienced researchers alike will benefit from the troubleshooting guide in each chapter, the extensive reference lists for advanced reading and the great practical experience of the authors. Practical Methods in Cardiovascular Research is therefore a long awaited "must have" for anybody with an interest in cardiovascular research.

Planning for a Career in Biomedical and Life Sciences:Learn to Navigate a Tough Research Culture by Harnessing the Power of Career Building, Second Edition, presents useful information, insights and tips to those pursuing a career in the biomedical and life sciences. The book focuses on making educated choices during schooling, training, and the job search in both the academic and non-academic sectors. The book's premise lies in the notion that if users understand the full path of a career in either the biomedical or life science fields, they can proactively plan their career, recognize any opportunities that present themselves, and be well prepared to address important aspects of their own professional development. Topics include choosing a training path, selecting the best supervisor/mentor, and negotiating a job offer. Updates to this edition include an outline of core competencies to achieve success, how to build soft skills and tailor them to specific job opportunities, and how to increase collaborations across disciplines. Additionally, coverage on issues around diversity, health, wellness and work/life balance are expanded. This book is a valuable resource for undergraduate, graduate, medical and postdoctoral students in the biomedical and life sciences, as well as academic faculty and advisors.

Keys to Running Successful Research Projects: All the Things They Never Teach You provides a step-by-step guide for the management of a successful research project or program. Through the use of illustrative case studies, the book covers all aspects of management that should be included during researcher training, helping researchers overcome the many challenges they face in their day-to-day management of people, time and resources. Links throughout provide more detailed information from gold standard sources on every topic. It is a must-have reference for postdocs, research managers and administrators in colleges, universities, hospitals and research institutes. In addition, it is an ideal resource for those working in grant and contract funding groups in the life sciences and medical fields.

**THE SUNDAY TIMES BESTSELLER | BBC RADIO 4 BOOK OF THE WEEK** Preventable tells the extraordinary story of COVID-19 and how global politics shape our health - from a world-leading expert and the pandemic's go-to science communicator Professor Devi Sridhar has risen to prominence for her vital roles in communicating science to the public and speaking truth to power. In Preventable she highlights lessons learned from outbreaks past and present in a narrative that traces the COVID-19 pandemic - including her personal experience as a scientist - and sets out a vision for how we can better protect ourselves from the inevitable health crises to come. In gripping and heartfelt prose, Sridhar exposes the varied realities of those affected (from the jailed doctor in Wuhan who sounded the alarm, and the bored passengers marooned on the Diamond Princess cruise ship, to the daily nightmares of exhausted healthcare workers), and puts you in the room with key decision makers at crucial moments (from over-confident heads of states and their hesitant scientific advisors, to the beleaguered leaders of global health organisations). Sridhar vibrantly conveys the twists and turns of a plot that saw: deadlier variants emerge (contrary to the predictions of social media pundits who argued it would mutate to a milder form); the Pyrrhic victory in many countries of the false narrative of health versus the economy (those countries which controlled the virus, like Taiwan and Denmark, had a steadier recovery); countries with weak health systems like Senegal and Vietnam fare better than countries like the US and UK (which were consistently ranked as the most prepared); and the quickest development of game-changing vaccines in history (and their unfair distribution). Combining science, politics, ethics and economics, this definitive book dissects the global structures that determine our fate, and reveals the deep-seated economic and social inequalities at their heart - it will challenge, outrage and inspire. 'A brutally compelling reminder that if voices like Devi's had been listened to, so many more could have lived' OWEN JONES 'One of the most brilliant scientists in the world who has been proven consistently right in this crisis' PIERS MORGAN 'Excellent . . . Fair, clear and compelling' NICOLA STURGEON 'Those who have found Professor Devi Sridhar's expertise and calm advice invaluable since the arrival of Covid-19 will be glad to know that she has written Preventable' RACHEL COOKE, Guardian, Non-fiction to look out for in 2022

This book contains an extensive collection of critical reviews, from leading researchers in the field of regulated protein degradation. It covers the role of regulated proteolysis in a range of microorganisms (from Gram positive, Gram negative and pathogenic bacteria to Archaea and the Baker s yeast Saccharomyces cerevisiae)."

Phillips and Ruth Thygeson were pioneers in medical research on external diseases of the human eye. Together, this husband-and-wife team shared a mutual story of extraordinary accomplishment including, among other things, the discovery of the cause and the cure of trachoma, a potentially blinding disease that affects millions of people worldwide.This comprehensive biography tells the complete story of their personal lives and careers. Beginning with each of their childhoods, the story continues through their meeting on the campus of Stanford University, their years of practicing ""frontier medicine"" in rural Colorado (where they built a log cabin with their own hands), their world travels in search of a cure for trachoma, and their considerable roles in establishing the Francis I. Proctor Foundation for Research in Ophthalmology. The story of this couple is one of a lifelong collaboration in medicine, a 70-year love affair, and an unending quest to conquer preventable blindness around the world.

This contributed volume gathers the latest knowledge in the field of stem cells in human reproductive organs, as well as animal models, and to consider the possibility of using this knowledge for clinical purposes. The scope of the book covers both clinical and basic knowledge of stem cells in both reproductive medicine (gynecology and obstetrics) and regenerative medicine as well as cellular and molecular medicine and reproductive biology. Chapters on basic stem cell knowledge in human reproductive tissues and organs or animal models are included, as well as clinical knowledge on their role in the manifestation of infertility and cancer and their clinical use.

Gives a convenient summary of trials in Gynecologic Oncology Supplies an invaluable revision primer for those undertaking certification Provides a uniquely up-to-date resource

The Liver: Oxidative Stress and Dietary Antioxidants takes a novel approach to the science of oxidative stress in liver disease by recognizing that diseases are multifactorial and oxidative stress is a single component. It highlights oxidative stress in relation to other processes, such as apoptosis, cell signaling and receptor mediated responses, and includes the therapeutic usage of natural antioxidants in the diet and food matrix, along with coverage of pharmacological and natural agents designed to counteract oxidative stress. Written for research scientists, gastroenterologists, food scientists, hepatologists and physicians, this trans-disciplinary guide will help advance medical sciences and enable new preventative and treatment strategies.

This book addresses hot issues in the research and management of difficult-to-treat medical disorders that are commonly encountered, but for which the underlying mechanisms are often unknown. These include the adverse effects of hemodialysis and its biocompatibility in chronic kidney insufficiency, particularly related to malnutrition and inflammation, or the vulnerability of cancer patients to bacterial meningitis, the infection that remains underdiagnosed due to limited expression of symptoms. The book also covers other key topics, such as the psychological care of lung cancer patients; difficulties in the diagnosis of diffuse axonal injury in traumatic brain injury - a disorder with a poor prognosis and high mortality rate; and the virological aspects of seasonal influenza epidemic outbreaks - a perennial modern scourge. Further, it addresses recent developments in targeted drug delivery from titanium implants and a novel integrated thermal approach to rehabilitation of neurodegeneration-related disabilities. Featuring the latest interdisciplinary trends in biomedicine, this book connects research, theory and practice to help alleviate suffering caused by a variety of diseases. It is a resource for medical professionals, including academics, practitioners and all allied healthcare workers.

Features Represents the first book to provide comprehensive coverage of model-assisted designs for various types of dose-finding and optimization clinical trials Describes the up-to-date theory and practice for model-assisted designs Presents many practical challenges and issues arising from early-phase clinical trials Illustrates with many real trial applications Offers numerous tips and guidance on designing dose finding and optimization trials Provides step-by-step illustration of using software to design trials Develops a companion website (www.trialdesign.org) to provide easy-to-use software to assist learning and implementing model-assisted designs.

This detailed volume explores the methods used for most of the recent approaches to suicide gene therapy of cancer, which exploits promoters that are specific to cancer cells, thereby ensuring (or greatly increasing the likelihood) that the therapeutic gene is expressed only in cancer cells. The book also contains chapters describing methods to improve the safety of cell therapy and techniques utilizing bone marrow mesenchymal cells. 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 practical, Suicide Gene Therapy: Methods and Protocols serves as an ideal guide for researchers expanding upon our knowledge and application of this vital form of cancer therapy.

The aim of this unique volume is to help medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables the researcher-with no background in statistics-to determine sample size and write statistical considerations for their protocols. It provides critical language which can help with FDA submissions and/or research grants. It also provides the mathematical justification of the material at a level consistent with one year of undergraduate mathematical statistics. It presents survival analysis methods at a more elementary level than any known text. Filled with tables, figures, plus an extensive appendix, this one-of-a-kind reference is an absolute must for all clinical researchers and biostatisticians.

In Silico Drug Discovery and Design: Theory, Methods, Challenges, and Applications provides a comprehensive, unified, and in-depth overview of the current methodological strategies in computer-aided drug discovery and design. Its main aims are to introduce the theoretical framework and algorithms, discuss the range of validity, strengths and limitations of each methodology, and present applications to real world problems in the drug discovery arena. Special emphasis has been given to the emerging and most pressing methodological challenges in in silico drug discovery and design. The book assumes a basic knowledge of physical principles and molecular modeling. Particular attention has been paid to outline the underlying physico-chemical foundation of the methods described, thus providing the necessary background to avoid a "black-box" approach. In each self-contained chapter, this is presented together with the latest developments and applications, and the challenges that lie ahead. Assembling a unique team of experts to weigh in on the most important issues influencing modern computational drug discovery and design, this book constitutes both a desktop reference to academic and industrial researchers in the field, and a textbook for students in the area of molecular modeling and drug discovery. Comprised of 18 chapters and divided into three parts, this book: Provides a comprehensive, unified, and in-depth overview of the current methodological strategies in computer-aided drug discovery and design Outlines the underlying physico-chemical foundation of the methods described Presents several applications of computational methods to real world problems in the drug design field Helps to avoid a "black-box" approach to in silico drug discovery Constitutes an actual textbook for students in the area of molecular modeling and drug discovery Gives the reader the adequate background to face the current challenges of the field In Silico Drug Discovery and Design: Theory, Methods, Challenges, and Applications describes the theoretical framework, methods, practical applications and case examples relevant to computer-aided drug lead discovery and design. This text will surely aid in understanding the underlying physical foundation of computational tools and their range of application, thus facilitating the interpretation of simulation results.

This detailed book provides an accessible compendium of up-to-date methods in the fields of environmental toxicology, molecular toxicology, and toxicogenomics. Organized into four major sections, the volume examines methods utilizing model animal species, such as nematode, fruit fly, mice, chicken, and amphibians, methods using plants to study chemical toxicity, applying the Ames assay to chemical mutagenicity study, as well as methods for environmental chemical analysis. Although this book is divided into these parts, the methods can be used across species. 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 practical, Environmental Toxicology and Toxicogenomics: Principles, Methods, and Applications serves as a valuable resource for the scientific community, particularly for young scientists and graduate and undergraduate students, inspiring more research in the vitally important field of environmental toxicity, molecular toxicology, and toxicogenomics.

Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making. This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.