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Here you'll find more than 500 entries from the world's leading experts in the field on the basic concepts, methodologies, and applications in clinical trials. The range of topics includes: basic statistical concepts, design and analysis of clinical trials, ethics, regulatory issues, and methodologies for clinical data management and analysis
There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. * Provides a practical overview of data monitoring in clinical trials. * Describes the purpose, responsibilities and operation of data monitoring committees. * Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. * Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. * Discusses issues pertinent to those working in clinical trials in both the US and Europe. The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.
A comprehensive approach to sample size determination and power with applications for a variety of fields Sample Size Determination and Power features a modern introduction to the applicability of sample size determination and provides a variety of discussions on broad topics including epidemiology, microarrays, survival analysis and reliability, design of experiments, regression, and confidence intervals. The book distinctively merges applications from numerous fields such as statistics, biostatistics, the health sciences, and engineering in order to provide a complete introduction to the general statistical use of sample size determination. Advanced topics including multivariate analysis, clinical trials, and quality improvement are addressed, and in addition, the book provides considerable guidance on available software for sample size determination. Written by a well-known author who has extensively class-tested the material, Sample Size Determination and Power: Highlights the applicability of sample size determination and provides extensive literature coverage Presents a modern, general approach to relevant software to guide sample size determination including CATD (computer-aided trial design) Addresses the use of sample size determination in grant proposals and provides up-to-date references for grant investigators An appealing reference book for scientific researchers in a variety of fields, such as statistics, biostatistics, the health sciences, mathematics, ecology, and geology, who use sampling and estimation methods in their work, Sample Size Determination and Power is also an ideal supplementary text for upper-level undergraduate and graduate-level courses in statistical sampling.
The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies Designed for students with basic knowledge of epidemiology and public health Includes many case studies to illustrate pharmacoepidemiology in real clinical setting
The most up-to-date coverage on adult psychopathology Adult Psychopathology and Diagnosis, Fifth Edition offers comprehensive coverage of the major psychological disorders and presents a balanced integration of empirical data and diagnostic criteria to demonstrate the basis for individual diagnoses. The accessible format and case study approach provide the opportunity to understand how diagnoses are reached. Updated to reflect the rapid developments in the field of psychopathology, this Fifth Edition encompasses the most current research in the field including: A thorough introduction to the principles of the DSM-IV-TR classification system and its application in clinical practice The biological and neurological foundations of disorders and the implications of psychopharmacology in treatment Illustrative case material as well as clinical discussions addressing specific disorders, diagnostic criteria, major theories of etiology, and issues of assessment and measurement Coverage of the major diagnostic entities and problems seen in daily clinical work by those in hospitals, clinics, and private practice A new chapter on race and ethnicity by renowned expert Stanley Sue
Mixed methods research combines quantitative and qualitative research methods in a single study. The use of mixed methods research is increasingly popular in nursing and health sciences research. This growth in popularity has been driven by the increasing complexity of research problems relating to human health and wellbeing. Mixed Method Research for Nursing and the Health Sciences is an accessible, practical guide to the design, conduct and reporting of mixed method research in nursing or the health sciences. Each chapter stands alone, describing the various steps of the research process, but contains links to other chapters. Within the text, ‘real-life’ examples from the published literature, doctoral theses and the unpublished work of the authors, illustrate the concepts being discussed. Places mixed methods research within its contemporary context Includes international contributions from UK, Australia, NZ and USA Provides an accessible introduction to theoretical and philosophical underpinnings Demystifies strategies for analysing mixed methods data Examines strategies for publishing mixed methods research Includes learning objectives and exemplars in each chapter Final chapters provide ‘real-life’ examples of applied research About the Authors: Sharon Andrew is Head of Program (Postgraduate) and Elizabeth J. Halcomb is Senior Lecturer, School of Nursing & Midwifery, University of Western Sydney. Also of Interest: The Research Process in Nursing (Fifth Edition) Edited by Kate Gerrish and Anne Lacey 978-14051-3013-4 Research Handbook for Healthcare Professionals Mary Hickson 978-14051-7737-5 Real World Research: A Resource for Social Scientists and Practitioner-Researchers Second edition Colin Robson 978-0631-21305-5 Reviewing Research Evidence for Nursing Practice: Systematic Reviews Edited by Christine Webb and Brenda Roe 978-14051-4423-0
Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.
The Encyclopedia of RESEARCH METHODS IN CRIMINOLOGY & CRIMINAL JUSTICE The most comprehensive reference work on research designs and methods in criminology and criminal justice This Encyclopedia of Research Methods in Criminology and Criminal Justice offers a comprehensive survey of research methodologies and statistical techniques that are popular in criminology and criminal justice systems across the globe. With contributions from leading scholars and practitioners in the field, it offers a clear insight into the techniques that are currently in use to answer the pressing questions in criminology and criminal justice. The Encyclopedia contains essential information from a diverse pool of authors about research designs grounded in both qualitative and quantitative approaches. It includes information on popular datasets and leading resources of government statistics. In addition, the contributors cover a wide range of topics such as: the most current research on the link between guns and crime, rational choice theory, and the use of technology like geospatial mapping as a crime reduction tool. This invaluable reference work: Offers a comprehensive survey of international research designs, methods, and statistical techniques Includes contributions from leading figures in the field Contains data on criminology and criminal justice from Cambridge to Chicago Presents information on capital punishment, domestic violence, crime science, and much more Helps us to better understand, explain, and prevent crime Written for undergraduate students, graduate students, and researchers, The Encyclopedia of Research Methods in Criminology and Criminal Justice is the first reference work of its kind to offer a comprehensive review of this important topic.
Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features: • Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems • Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index • Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials
This book introduces the methodology for collection and identification of herbal materials, extraction and isolation of compounds from herbs, in vitro bioassay, in vivo animal test, toxicology, and clinical trials of herbal research. To fully understand and make the best use of herbal medicines requires the close combination of chemistry, biochemistry, biology, pharmacology, and clinical science. Although there are many books about traditional medicines research, they mostly focus on either chemical or pharmacological study results of certain plants. This book, however, covers the systematic study and analysis of herbal medicines in general – including chemical isolation and identification, bioassay and mechanism study, pharmacological experiment, and quality control of the raw plant material and end products.