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.

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.

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.

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

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.

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.