Behavioral Clinical Trials For Chronic Diseases
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| Author | : Lynda H. Powell |
| Publisher | : Springer Nature |
| Total Pages | : 324 |
| Release | : 2021-10-13 |
| Genre | : Psychology |
| ISBN | : 3030393305 |
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 221 |
| Release | : 2001-01-01 |
| Genre | : Medical |
| ISBN | : 0309171148 |
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.
| Author | : Kerm Henriksen |
| Publisher | : |
| Total Pages | : 526 |
| Release | : 2005 |
| Genre | : Medical |
| ISBN | : |
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 236 |
| Release | : 2015-04-20 |
| Genre | : Medical |
| ISBN | : 0309316324 |
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.
| Author | : Lynda H. Powell |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2021 |
| Genre | : |
| ISBN | : 9783030393298 |
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.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 127 |
| Release | : 2019-11-16 |
| Genre | : Medical |
| ISBN | : 0309494885 |
Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 335 |
| Release | : 2017-12-21 |
| Genre | : Medical |
| ISBN | : 0309462568 |
Since 1938 and 1941, nutrient intake recommendations have been issued to the public in Canada and the United States, respectively. Currently defined as the Dietary Reference Intakes (DRIs), these values are a set of standards established by consensus committees under the National Academies of Sciences, Engineering, and Medicine and used for planning and assessing diets of apparently healthy individuals and groups. In 2015, a multidisciplinary working group sponsored by the Canadian and U.S. government DRI steering committees convened to identify key scientific challenges encountered in the use of chronic disease endpoints to establish DRI values. Their report, Options for Basing Dietary Reference Intakes (DRIs) on Chronic Disease: Report from a Joint US-/Canadian-Sponsored Working Group, outlined and proposed ways to address conceptual and methodological challenges related to the work of future DRI Committees. This report assesses the options presented in the previous report and determines guiding principles for including chronic disease endpoints for food substances that will be used by future National Academies committees in establishing DRIs.
| Author | : Wendy Bohaychuk |
| Publisher | : John Wiley & Sons |
| Total Pages | : 234 |
| Release | : 1999-06-02 |
| Genre | : Medical |
| ISBN | : 9780471988243 |
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 350 |
| Release | : 2011-06-30 |
| Genre | : Medical |
| ISBN | : 0309221277 |
In the United States, chronic diseases currently account for 70 percent of all deaths, and close to 48 million Americans report a disability related to a chronic condition. Today, about one in four Americans have multiple diseases and the prevalence and burden of chronic disease in the elderly and racial/ethnic minorities are notably disproportionate. Chronic disease has now emerged as a major public health problem and it threatens not only population health, but our social and economic welfare. Living Well with Chronic Disease identifies the population-based public health actions that can help reduce disability and improve functioning and quality of life among individuals who are at risk of developing a chronic disease and those with one or more diseases. The book recommends that all major federally funded programmatic and research initiatives in health include an evaluation on health-related quality of life and functional status. Also, the book recommends increasing support for implementation research on how to disseminate effective longterm lifestyle interventions in community-based settings that improve living well with chronic disease. Living Well with Chronic Disease uses three frameworks and considers diseases such as heart disease and stroke, diabetes, depression, and respiratory problems. The book's recommendations will inform policy makers concerned with health reform in public- and private-sectors and also managers of communitybased and public-health intervention programs, private and public research funders, and patients living with one or more chronic conditions.
| Author | : Edwin B. Fisher |
| Publisher | : Springer |
| Total Pages | : 1132 |
| Release | : 2018-10-08 |
| Genre | : Psychology |
| ISBN | : 0387938265 |
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.
