On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.
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.
Advances and major investments in the field of neuroscience can enhance traditional behavioral science approaches to training, learning, and other applications of value to the Army. Neural-behavioral indicators offer new ways to evaluate how well an individual trainee has assimilated mission critical knowledge and skills, and can also be used to provide feedback on the readiness of soldiers for combat. Current methods for matching individual capabilities with the requirements for performing high-value Army assignments do not include neuropsychological, psychophysiological, neurochemical or neurogenetic components; simple neuropsychological testing could greatly improve training success rates for these assignments. Opportunities in Neuroscience for Future Army Applications makes 17 recommendations that focus on utilizing current scientific research and development initiatives to improve performance and efficiency, collaborating with pharmaceutical companies to employ neuropharmaceuticals for general sustainment or enhancement of soldier performance, and improving cognitive and behavioral performance using interdisciplinary approaches and technological investments. An essential guide for the Army, this book will also be of interest to other branches of military, national security and intelligence agencies, academic and commercial researchers, pharmaceutical companies, and others interested in applying the rapid advances in neuroscience to the performance of individual and group tasks.
An "elegant", "engrossing" (Carol Tavris, Wall Street Journal) examination of what we think we know about the brain and why -- despite technological advances -- the workings of our most essential organ remain a mystery. "I cannot recommend this book strongly enough."--Henry Marsh, author of Do No Harm For thousands of years, thinkers and scientists have tried to understand what the brain does. Yet, despite the astonishing discoveries of science, we still have only the vaguest idea of how the brain works. In The Idea of the Brain, scientist and historian Matthew Cobb traces how our conception of the brain has evolved over the centuries. Although it might seem to be a story of ever-increasing knowledge of biology, Cobb shows how our ideas about the brain have been shaped by each era's most significant technologies. Today we might think the brain is like a supercomputer. In the past, it has been compared to a telegraph, a telephone exchange, or some kind of hydraulic system. What will we think the brain is like tomorrow, when new technology arises? The result is an essential read for anyone interested in the complex processes that drive science and the forces that have shaped our marvelous brains.
Biomarkers, or biological markers, are quantitative measurements that offer researchers and clinicians valuable insight into diagnosis, treatment and prognosis for many disorders and diseases. A major goal in neuroscience medical research is establishing biomarkers for disorders of the nervous system. Given the promising potential and necessity for neuroscience biomarkers, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened a public workshop and released the workshop summary entitled Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships. The workshop brought together experts from multiple areas to discuss the most promising and practical arenas in neuroscience in which biomarkers will have the greatest impact. The main objective of the workshop was to identify and discuss biomarker targets that are not currently being aggressively pursued but that could have the greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders.
Multiple sclerosis is a chronic and often disabling disease of the nervous system, affecting about 1 million people worldwide. Even though it has been known for over a hundred years, no cause or cure has yet been discovered-but now there is hope. New therapies have been shown to slow the disease progress in some patients, and the pace of discoveries about the cellular machinery of the brain and spinal cord has accelerated. This book presents a comprehensive overview of multiple sclerosis today, as researchers seek to understand its processes, develop therapies that will slow or halt the disease and perhaps repair damage, offer relief for specific symptoms, and improve the abilities of MS patients to function in their daily lives. The panel reviews existing knowledge and identifies key research questions, focusing on: Research strategies that have the greatest potential to understand the biological mechanisms of recovery and to translate findings into specific strategies for therapy. How people adapt to MS and the research needed to improve the lives of people with MS. Management of disease symptoms (cognitive impairment, depression, spasticity, vision problems, and others). The committee also discusses ways to build and financially support the MS research enterprise, including a look at challenges inherent in designing clinical trials. This book will be important to MS researchers, research funders, health care advocates for MS research and treatment, and interested patients and their families.
An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.
Animals are widely used in neuroscience research to explore biological mechanisms of nervous system function, to identify the genetic basis of disease states, and to provide models of human disorders and diseases for the development of new treatments. To ensure the humane care and use of animals, numerous laws, policies, and regulations are in place governing the use of animals in research, and certain animal regulations have implications specific to neuroscience research. To consider animal research regulations from a global perspective, the IOM Forum on Neuroscience and Nervous System Disorders, in collaboration with the National Research Council and the Institute for Laboratory Animal Research, held a workshop in Buckinghamshire, UK, July 26-27, 2011. The workshop brought together neuroscientists, legal scholars, administrators, and other key stakeholders to discuss current and emerging trends in animal regulations as they apply to the neurosciences. This document summarizes the workshop.
Drugs and the Future presents 13 reviews collected to present the new advances in all areas of addiction research, including knowledge gained from mapping the human genome, the improved understanding of brain pathways and functions that are stimulated by addictive drugs, experimental and clinical psychology approaches to addiction and treatment, as well as both ethical considerations and social policy. The book also includes chapters on the history of addictive substances and some personal narratives of addiction. Introduced by Sir David King, Science Advisory to the UK Government and head of the Office of Science and Technology, and Nora Volkow, director of the National Institute on Drug Abuse in the USA, the book uniquely covers the full range of disciplines which can provide insight into the future of addiction, from genetics to the humanities. Written for a scientific audience, it is also applicable to non-specialists as well. - Provides an unique overview of what we know about addiction, and how scientific knowledge can and should be applied in the societal, ethical, and political context - Applies the state-of-the-art research in fields such as Genomics, Neuroscience, Pharmacology, Social Policy and Ethics to addiction research - Includes a preface by Sir David King, Science Advisory to the UK Government and head of the Office of Science and Technology, and in introduction by Nora Volkow, director of the National Institute on Drug Abuse in the USA
