The Wiley-Blackwell Handbook of Mood Disorders, 2/e reflects the important and fast-changing advancements that have occurred in theory and practice in unipolar and bipolar mood disorders. There is no other current reference that gathers all of these developments together in a single book Every chapter is updated to reflect the very latest developments in theory and practice in unipolar and bipolar mood disorders Includes additional chapters which cover marital and family therapy, medical disorders and depression, and cross-cultural issues Contributions are from the world's leading authorities, and include psychiatrists and clinical psychologists with experience in both research and in practice Focuses on innovations in science and clinical practice, and considers new pharmacological treatments as well as psychological therapies
A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Clinical Governance: A Guide to Implementation for Healthcare Professionals provides a comprehensive overview of what is meant by clinical governance and how it can be implemented in practice. It explores the evolution of clinical governance, its key components, legal implications, the barriers to implementing it, and its impact. Clinical Governance provides step-by-step practical advice, facilitating better understanding of the key principles of clinical governance. This third edition has been fully updated throughout to incorporate a more integrated approach to achieving clinical governance, with an additional chapter on education and training. Each chapter includes reflective questions, activities and case studies taken from clinical practice as well as a full list of references and further reading.
Through a compilation of original articles, the Handbook of Jealousy offers an integrated portrait of the emerging areas of research into the nature of jealousy and a forum for discussing the implications of the findings for theories of emotional and socio-cognitive development. Presents the most recent findings and theories on jealousy across a range of contexts and age-stages of development Includes 23 original articles with empirical findings and detailed commentaries by leading experts in the field Serves as a valuable resource for professionals in the fields of clinical psychology, psychiatry, and social work, as well as scholars in the fields of psychology, family studies, sociology, and anthropology
An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.
Praise for the Second Edition: “…a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: • New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine • A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts • New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines • An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.
The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical «nuts and bolts» approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.
This handbook provides a comprehensive review of new developments in the study of the relationship between the brain and language, from the perspectives of both basic research and clinical neuroscience. Includes contributions from an international team of leading figures in brain-language research Features a novel emphasis on state-of-the-art methodologies and their application to the central questions in the brain-language relationship Incorporates research on all parts of language, from syntax and semantics to spoken and written language Covers a wide range of issues, including basic level and high level linguistic functions, individual differences, and neurologically intact and different clinical populations
Still the most comprehensive reference source on the development, production and therapeutic application of antibodies, this second edition is thoroughly updated and now has 30% more content. Volume 1 covers selection and engineering strategies for new antibodies, while the second volume presents novel therapeutic concepts and antibodies in clinical study, as well as their potential. Volumes 3 and 4 feature detailed and specific information about each antibody approved for therapeutic purposes, including clinical data. This unique handbook concludes with a compendium of marketed monoclonal antibodies and an extensive index. Beyond providing current knowledge, the authors discuss emerging technologies, future developments, and intellectual property issues, such that this handbook meets the needs of academic researchers, decision makers in industry and healthcare professionals in the clinic.
Although clinical trials were virtually unheard of in psychiatry for many years, they are now the gold standard for judging whether drugs are safe and useful. But should they be? What is the true status of clinical trials? Even when they ostensibly demonstrate a benefit of a certain treatment, the strict patient selection criteria, poor compliance and high drop-out rate leave the conclusions open to question. Are the new treatments really better or more cost-effective than the old? Do they have fewer side effects? In this book the authors take a critical look at recent developments and present a series of trenchant and challenging observations. Section I examines the significant changes in law and the regulatory environment that have occurred during the past ten years. Has fossilization handicapped the US Food and Drug Administration in promoting treatment advances? How can the plethora of findings be regulated? This is particularly pertinent in genomic studies and there are two chapters addressing the impact of genomics on psychiatric research. This section also addresses the role of women in drug trials – a group long excluded but now demanding a part, for without testing how can optimal treatments be devised? The next two Sections highlight clinical trials in the major areas of psychiatric pharmacological treatment, including Mood Disorders, especially Bipolar, Anxiety Disorders, and addictions. Chapters on pharmacological treatments for Eating Disorders, Attention Deficit Disorder, Autism and Asperger’s Syndrome, and Impulse Control Disorder represent the latest thinking on these subjects. The final Section contains a consummate example of out-of-the [Western]– box thinking, namely consideration of herbal medicines – used by a large number of patients, with or without medical supervision. We conclude with a close look at the problem of side effects, then selected thoughts about methodology. Clearly written, the text provides immediate access to new developments across the spectrum of drug testing. Clinical Trials in Psychopharmacology: A Better Brain is provocative reading for psychiatrists, pharmacologists and all those interested in improved drug treatments for patients with mental illness. Raises questions about the conduct of trials and the credibility of their outcomes that are relevant not just in psychiatry but all areas of medicine Discusses the ethical problems in assessing outcomes in humans, including children
'I can enthusiastically recommend the Manual of Clinical Paramedic Procedures as the book that I wish had been available to me when I was studying to become a paramedic.' From the foreword by Professor Malcolm Woollard, Chair, College of Paramedics; Professor in Pre-hospital and Emergency Care & Director, Pre-hospital, Emergency & Cardiovascular Care Applied Research Group, Coventry University Clinical procedures are a fundamental aspect of care for practitioners working in pre-hospital settings. The Manual of Clinical Paramedic Procedures is written specifically to support the practice of paramedics, ambulance technicians, first responders and volunteer ambulance personnel. It presents up-to-date, evidence-based expert knowledge, enabling paramedics to deliver effective, patient-focused care. This accessible handbook provides a comprehensive exploration of core competencies and skills, looking at topics including Aseptic Technique, Airway Management, Assisted Ventilation, Cardiopulmonary Resuscitation, Defibrillation and External Cardiac Pacing, Observations, Pain Assessment & Management, Respiratory Therapy, Spinal Management and Venepuncture. Each chapter provides the relevant anatomy & physiology, evidence-based rationales for each procedure, and contraindications of use. Key features: The first UK text to explore clinical procedures for paramedics With further reading and illustrations throughout All procedures include the rationale for the action recommended Guides paramedics in the clinical application of evidence-based procedures
This book is designed to fill the need for a contemporary handbook for the practice of renal and pancreatic transplantation that is focussed on a European rather than North American approach. There are significant differences in transplant practice internationally and there is a need for a practical guide to application of the current evidence base.
Since 1960, the burden of adolescent illness has shifted from the traditional causes of disease to the more behavior-related problems, such as drinking, smoking and drug abuse (nearly half of American adolescents have used an illicit drug sometime during their life). Instilling in adolescents the knowledge, skills, and values that foster physical and mental health will require substantial changes in the way health professionals work and the way they connect with families, schools, and community organizations. At the same time, the major textbooks on addiction medicine and addiction psychiatry devote relatively little attention to the special problems of diagnosing and treating adolescent addicts. Similarly, the major textbooks on general and child and adolescent psychiatry direct relatively little attention to the issues surrounding adolescent addiction. The Clinical Handbook of Adolescent Addiction is one response to the challenge of meeting the mental health needs and behavior-related problems of addicted teenagers. The work has been edited as an independent project by members of the American Society for Adolescent Psychiatry, the oldest professional organization of psychiatrists devoted solely to the mental health care and treatment of teenagers in the USA. The forensic psychiatry perspective permeates the entire book. It will help to produce health providers with a deep and sensitive understanding of the developmental needs and behavior-related problems of adolescents. The Clinical Handbook of Adolescent Addiction is a practical tool for all those who help adolescents: practitioners of family medicine, general psychiatrists, child/adolescent psychiatrists, adolescent psychiatrists, addiction psychiatrists, non-psychiatric physicians specializing in addiction medicine, forensic psychiatrists, psychologists, clinical social workers, mental health administrators, Court/Probation/ Parole/Correctional health workers. The book is organized in a user-friendly format so that readers can easily locate the chapters that provide the information that is required. In some instances, topics of special importance deliberately have been addressed in more than one chapter, to illuminate the topics from a variety of vantage points. One aim of the editors is to move the topic from being a specialist area to a generalist one by providing tools for generalist to use.
Praise for Filipino American Psychology: A Handbook of Theory, Research, and Clinical Practice «Filipino American Psychology: A Handbook of Theory, Research, and Clinical Practice is destined to make a major contribution to the field of Asian American psychology and to the larger field of multicultural psychology.» —From the Foreword by Derald Wing Sue, PhD Professor of Psychology and Education, Teachers College, Columbia University «Dr. Nadal has done a superb job of locating the experiences of Filipino Americans within the larger scholarship on ethnic minority psychology, while also highlighting the complexity, richness, and uniqueness of their psychological experiences. This book should be a part of everyone's library.» —E.J.R. David, PhD Assistant Professor, Department of Psychology, University of Alaska Anchorage «Ranging from historical contexts to present-day case studies, theoretical models to empirical findings, self-reflection activities to online and media resources, Filipino American Psychology will engage, stimulate, and challenge both novices and experts. Without question, Dr. Nadal's book is a foundational text and a one-stop resource for both the Filipino American community and the community of mental health professionals.» —Alvin N. Alvarez, PhD Professor, San Francisco State University A landmark volume exploring contemporary issues affecting Filipino Americans, as well as the most successful mental health strategies for working with Filipino American clients Addressing the mental health needs of the Filipino American population—an often invisible, misunderstood, and forgotten group—Filipino American Psychology provides counselors and other mental health practitioners with the knowledge, awareness, and skills they can use to become effective and culturally competent when working with their Filipino American clients. Filipino American Psychology begins by looking at the unique cultural, social, political, economic, and mental health needs of Filipino Americans. Noted expert—and Filipino American—Kevin Nadal builds on a foundational understanding of the unique role and experience of Filipino Americans, offering strategies for more effective clinical work with Filipino Americans in a variety of settings. A must-read for mental health professionals as well as educators and students in the mental health field, Filipino American Psychology is an insightful look at the Filipino American community and the nuances of the Filipino American psyche.
Successful management of patients with treatment-resistant depression is going to require a thorough understanding of the biological basis for both the depression and its failure to respond to standard treatments. This book clearly and succinctly summarizes the latest scientific research and its applications in clinical practice. A first step is a clear definition of what constitutes treatment-resistant depression so that clinical trials and other studies are using common criteria, enabling comparison and meta-analysis of their outcomes. The opening chapter reviews definitions and predictors of originating from different fields and discusses their usefulness in clinical practice and clinical research. The next chapter proposes a new definition, adapting terminology from medicine. Biological classification requires identification of genetic risk factors: with gene variants accounting for 50% of the variance in the clinical outcomes of antidepressant treatments this is clearly a fruitful area of research. Chapter 3 describes several genes already associated with treatment-resistant depression and, while further work is needed to translate findings into clinical recommendations, predicts that genetic prediction of TRD could became a widespread clinical reality within a few years. Most patients with TRD will be treated pharmacologically and three chapters review the latest evidence for pharmacological best practice, including switching strategies for antidepressants, the role of antipsychotics and augmentation strategies to complement lithium. There are two major alternatives to pharmacotherapy: neuromodulation and psychotherapy. The brain intervention chapter summarizes clinical research and experience with electroconvulsive therapy, transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation and magnetic seizure therapy. The final chapter reviews the literature pertaining to the effectiveness of various forms of psychotherapy in patients who have not responded to antidepressant pharmacotherapy, revealing that patients who have not responded to one or two trials of antidepressant medication have a 30%-50% chance of responding to a focused psychotherapy. It proposes indications for psychotherapy in TRD and summarizes general therapeutic principles.
A user-friendly guide of best practice for leading groups in various settings and with different populations, which incorporates the latest developments in today's mental health marketplace. Features multiple theoretical perspectives and guidelines for running groups for diverse populations, in the US and worldwide Offers modern approaches and practical suggestions in a user-friendly and jargon-free style, with many clinical examples Includes a major component on resiliency and trauma relief work, and explores its impact on clinicians Accompanied by an online resource featuring discussions of psychotherapeutic techniques in practice