This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to “speak the language of medicine” through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.

Conducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including: Standard operating procedures for investigators Standard operating procedures for sponsors and CROs GCP - an indexed reference Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.

v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

The field of public health is primarily concerned with understanding and improving physical health from a large group perspective (i.e., communities and whole populations). The field of social neuroscience, on the other hand, is primarily concerned with examining brain-behavior relationships that unfold in a social context. Both of these are rapidly developing fields of inquiry, and their boundaries have only recently begun to overlap. This book discusses collaborative research findings at the intersection of social neuroscience and public health that promise to fundamentally change the way scientists, public health practitioners, and the general public view physical health within the larger social context. Eighteen chapters are organized under the following major sections: cognition and health outcomes; neuroscientific aspects of health communication; health behavior and the neurobiology of self-regulation; neurobiological processes in health decision making; ecological and social context; neuroscience methods; and future directions.

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.

Principles and Concepts of Behavioral Medicine A Global Handbook Edwin B. Fisher, Linda D. Cameron, Alan J. Christensen, Ulrike Ehlert, Brian Oldenburg, Frank J. Snoek and Yan Guo This definitive handbook brings together an international array of experts to present the broad, cells-to-society perspectives of behavioral medicine that complement conventional models of health, health care, and prevention. In addition to applications to assessment, diagnosis, intervention, and management, contributors offer innovative prevention and health promotion strategies informed by current knowledge of the mechanisms and pathways of behavior change. Its range of conceptual and practical topics illustrates the central role of behavior in health at the individual, family, community, and population levels, and its increasing importance to person-centered care. The broad perspectives on risk (e.g., stress, lifestyle), management issues (e.g., adherence, social support), and overarching concerns (e.g., inequities, health policy) makes this reference uniquely global as it addresses the following core areas: · The range of relationships and pathways between behavior and health. · Knowing in behavioral medicine; epistemic foundations. · Key influences on behavior and the relationships among behavior, health, and illness. · Approaches to changing behavior related to health. · Key areas of application in prevention and disease management. · Interventions to improve quality of life. · The contexts of behavioral medicine science and practice. Principles and Concepts of Behavioral Medicine opens out the contemporary world of behavior and health to enhance the work of behavioral medicine specialists, health psychologists, public health professionals and policymakers, as well as physicians, nurses, social workers and those in many other fields of health practice around the world.

Eating behavior is a major lifestyle-related influencing factor of non-communicable chronic diseases (NCDs), particularly overweight/obesity, and metabolism syndrome (MetS). Typically, eating behavior refers not only to dietary patterns but also to nutrient intake. From the public health perspective, population-based evidence regarding healthy eating is of significance for policy developments regarding NCDs prevention. Eating behavior is time and economic status dependent, which may change as age or/and socio-economic status changes. This occurs not only in developing societies but also in economically settled communities. Therefore, although relationships between eating behaviors (dietary pattern, nutrients intake) and specific NCDs have been examined in different societies, further investigations of population-level associations between eating behavior and NCDs in different subpopulations (general community residents, elders/children, or patients, etc), especially the interaction of eating behavior and other influences (e.g., physical activity) on NCDs, remains of continuing importance. Meanwhile, updating the dietary patterns and nutrient intake levels of different subpopulations is also necessary.