Veterinary Clinical Trials From Concept To Completion

Conceived and edited by Nigel Dent and Ramzan Visanji, Veterinary Clinical Trials form Concept to Completion is designed for both established practitioners and novices, offering alternative ways of conducting studies and ensuring that the studies are guided by Good Clinical Practices and are in compliance with regulations. Comprehensive in scope, it provides the scientific, biological, and regulatory background invaluable to teachers, researchers, and regulatory affairs staff, as well as those directly involved in clinical trials. The book covers: Objectives of the clinical study Control of the study Conduct of the study Regulation versus compliance Factors for success International harmonization activities Roles of the investigator, the monitor, and the practicing veterinarian Setting up GCP trials with particular animal species SOPs, the generic protocol, and the study report Contract research farms and multi-site studies Auditing With contributions from experts in every area of veterinary trials, the text has been organized with everyday use in mind. The chapters can be read sequentially for a comprehensive view or individually for coverage of particular topics and issues as needed. Drawing directly from the in-the-trenches experience of the editors and chapter authors, the book is a guide to methods that ensure studies meet regulatory compliance and strategies that ensure avoidance of common pitfalls.

Learning from Disease in Pets: A ‘One Health’ Model for Discovery is the first encompassing reference guide for veterinarians, researchers and physicians on conducting studies using spontaneous models of disease in animals. The study of naturally occurring disease in (pet) animals can help model our understanding of the biology, prevention and therapy of human and animal diseases. Studies of pet dogs, for instance, can aid treatment of complex medical problems such as cancer, orthopedic, cardiopulmonary, and neuro-inflammatory diseases, and zoonotic infections. Each chapter within this novel cross-species approach is contributed by a leader, or leaders, in their field of research. Using clinical trials to learn how pets with real diseases respond to therapy can lead to breakthroughs in human medicine, as well as benefiting pets suffering from otherwise debilitating illness. Despite similarities of diseases across species, there are very few spontaneous models of disease used in research compared with models where disease is induced in healthy laboratory animals. Many medical researchers and veterinarians have a multitude of questions regarding how to use naturally occurring diseases in pets for the discovery of treatments and diagnostics: this book will demonstrate how to safely make this happen. This book encourages veterinarians to build on and disseminate existing findings for the wider benefit of pets and humans. Many pets suffering from incurable illnesses may benefit from clinical trials; the book includes a section on the imperative communication styles necessary within the research environment and with clients, a compelling discussion on the ethics of using pets in veterinary clinical research, comprehensive tables of diseases that spontaneously occur in animals and humans, the regulatory requirements necessary to move therapy from benchside research to patient bedside, as well as intricate details on how to design a robust clinical study.

A comprehensive introduction to the role of epidemiology in veterinary medicine This fully revised and expanded edition of Veterinary Epidemiology introduces readers to the field of veterinary epidemiology. The new edition also adds new chapters on the design of observational studies, validity in epidemiological studies, systematic reviews, and statistical modelling, to deliver more advanced material. This updated edition begins by offering an historical perspective on the development of veterinary medicine. It then addresses the full scope of epidemiology, with chapters covering causality, disease occurrence, determinants, disease patterns, disease ecology, and much more. Veterinary Epidemiology, Fourth Edition: ● Features updates of all chapters to provide a current resource on the subject of veterinary epidemiology ● Presents new chapters essential to the continued advancement of the field ● Includes examples from companion animal, livestock, and avian medicine, as well as aquatic animal diseases ● Focuses on the principles and concepts of epidemiology, surveillance, and diagnostic-test validation and performance ● Includes access to a companion website providing multiple choice questions Veterinary Epidemiology is an invaluable reference for veterinary general practitioners, government veterinarians, agricultural economists, and members of other disciplines interested in animal disease. It is also essential reading for epidemiology students at both the undergraduate and postgraduate levels.

"This reference book is the first encompassing guide for veterinarians, researchers and physicians on conducting studies using spontaneous models of disease in animals. The study of naturally-occurring disease in (pet) animals can help model our understanding of the biology, prevention and therapy of human and animal diseases. Studies of pet dogs, for instance, can aid treatment of complex medical problems such as cancer, orthopedic, cardiopulmonary, neuro-inflammatory disease, and zoonotic infections. Each chapter within this novel cross-species approach is contributed by a leader, or leaders, in their field of research. Using clinical trials to learn how pets with real disease respond to therapy can lead to breakthroughs in human medicine, as well as benefiting pets suffering from otherwise debilitating illness. Despite similarities of diseases across species, there are very few spontaneous models of disease used in research compared with models where disease is induced in healthy laboratory animals. Many medical researchers and veterinarians have a multitude of questions regarding how to use naturally-occurring disease in pets for the discovery of treatments and diagnostics: this book will demonstrate how to safely make this happen. The book encourages veterinarians to build on and disseminate existing findings for the wider benefit of pets and humans. Many pets suffering from disease may benefit from clinical trials because they suffer from incurable illnesses. This book includes a section on the imperative communication styles necessary within the research environment and with clients, a compelling discussion on the ethics of using pets in veterinary clinical research, comprehensive tables of diseases that spontaneously occur in animals and man, the regulatory requirements necessary to move therapy from benchside research to patient bedside, as well as intricate details on how to design a robust clinical study"--

Research in veterinary science is critical for the health and well-being of animals, including humans. Food safety, emerging infectious diseases, the development of new therapies, and the possibility of bioterrorism are examples of issues addressed by veterinary science that have an impact on both human and animal health. However, there is a lack of scientists engaged in veterinary research. Too few veterinarians pursue research careers, and there is a shortage of facilities and funding for conducting research. This report identifies questions and issues that veterinary research can help to address, and discusses the scientific expertise and infrastructure needed to meet the most critical research needs. The report finds that there is an urgent need to provide adequate resources for investigators, training programs, and facilities involved in veterinary research.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

The first accessible information on how to carry out veterinary clinical research. This book is an aid to increasing the quantity and quality of such research within veterinary clinical practice. Covering all the core research methods as well as aspects specific to veterinary medicine. Clinical research aims to optimize decision making in practice by answering questions on the best diagnostic options and treatments. Reading this book will help you take the intellectually rewarding step towards improving prognoses and outcomes through informed decisions. Special attention is given to ethical and legal issues, how to maximise the power of studies when faced with small numbers of patients, and how to go about research with few obvious resources to hand.

4* Doody's Review! Ideal for veterinary students, residents and clinicians, the fourth edition of this bestselling textbook has been fully updated in line with developments in research and teaching. The logical chapter progression reflects the stages in a clinical case work-up and how epidemiological concepts and methods contribute. This new edition provides guidelines for improving patient and population health outcomes, and detecting emerging diseases through systematic evaluation of patient encounters and electronic medical records incorporates new methodologies and concepts drawn from the recent veterinary practice literature updates chapter content including expanded coverage of risk, statistical and economic analyses, and surveillance for emerging diseases more than 60 examples of clinical research drawn from the international veterinary practice literature presented as structured abstracts; follow-up questions invite the reader to participate in the analysis of results online links to full text versions of more than half of structured abstracts and more than 40% of the book’s 174 literature citations updates the listing and review of public and private online resources, including guidelines for online literature searching and critical evaluation of clinical reports. Today’s veterinary curricula places greater emphasis on experiential/problem-based learning versus discipline-oriented instruction. This fourth edition is ideally suited to introduce epidemiologic concepts and methodologies to veterinary students in the context of the patient encounter, and should be of use at any point in the veterinary curriculum.