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Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Mental, neurological, and substance use disorders are common, highly disabling, and associated with significant premature mortality. The impact of these disorders on the social and economic well-being of individuals, families, and societies is large, growing, and underestimated. Despite this burden, these disorders have been systematically neglected, particularly in low- and middle-income countries, with pitifully small contributions to scaling up cost-effective prevention and treatment strategies. Systematically compiling the substantial existing knowledge to address this inequity is the central goal of this volume. This evidence-base can help policy makers in resource-constrained settings as they prioritize programs and interventions to address these disorders.
This single-volume reference covers the natural course, treatment, and management of all neurological diseases affecting the brain, spinal cord nerves and muscles. This comprehensive text reference seeks to assist physicians with treatment by providing an easy-to-use compendium covering the treatment and management of all neurological diseases along with details on the natural course of these diseases. Organized for ease of use and quick reference, each chapter presents a neurological disorder or key symptoms and systematically discusses the clinical syndrome and differential diagnosis, natural course, principles of therapy, and practical management of each. Covers wide range of neurological conditions and potential treatments, including the evidence for and against each treatment Describes the spontaneous course of neurological diseases along with discussion of the management of different stages and variants of a disorder Presents special situations and exceptional cases in which alternative therapies should be considered
Most neurological disorders are chronic and aging-related. With the increase of life expectancy their incidence and prevalence will grow in the decades to come, which in turn will increase the load on medical and social systems worldwide. There is thus a desperate need for successful preventive and therapeutic measures based on randomized clinical trials (RTCs) conducted by independent organizations. This book provides a compendium relating most of the principles of reliable RTCs to specific neurological diseases. Contributed by specialized neurologists, the articles touch on important aspects of RCTs with a clear critical approach, highlighting their limitations as well as giving recommendations for their planning and conducting to address the variable genotypic and phenotypic aspects of neurological conditions. Consideration is also given to combining the clinical impact of the study results with patients’ values and the interests of pharmaceutical companies. Neurologists involved in clinical trials will certainly benefit from this book, which should become a basic text for all neurological courses dealing with evidence-based neurology.
Current data and trends in morbidity and mortality for the sub-Saharan Region as presented in this new edition reflect the heavy toll that HIV/AIDS has had on health indicators, leading to either a stalling or reversal of the gains made, not just for communicable disorders, but for cancers, as well as mental and neurological disorders.
Nervous system diseases and disorders are highly prevalent and substantially contribute to the overall disease burden. Despite significant information provided by the use of animal models in the understanding of the biology of nervous system disorders and the development of therapeutics; limitations have also been identified. Treatment options that are high in efficacy and low in side effects are still lacking for many diseases and, in some cases are nonexistent. A particular problem in drug development is the high rate of attrition in Phase II and III clinical trials. Why do many therapeutics show promise in preclinical animal models but then fail to elicit predicted effects when tested in humans? On March 28 and 29, 2012, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened the workshop "Improving Translation of Animal Models for Nervous System Disorders" to discuss potential opportunities for maximizing the translation of new therapies from animal models to clinical practice. The primary focus of the workshop was to examine mechanisms for increasing the efficiency of translational neuroscience research through discussions about how and when to use animal models most effectively and then best approaches for the interpretation of the data collected. Specifically, the workshop objectives were to: discuss key issues that contribute to poor translation of animal models in nervous system disorders, examine case studies that highlight successes and failures in the development and application of animal models, consider strategies to increase the scientific rigor of preclinical efficacy testing, explore the benefits and challenges to developing standardized animal and behavioral models. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary also identifies methods to facilitate development of corresponding animal and clinical endpoints, indentifies methods that would maximize bidirectional translation between basic and clinical research and determines the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system.
Reprint of the original, first published in 1881.
Neuronal Networks in Brain Function, CNS Disorders, and Therapeutics, edited by two leaders in the field, offers a current and complete review of what we know about neural networks. How the brain accomplishes many of its more complex tasks can only be understood via study of neuronal network control and network interactions. Large networks can undergo major functional changes, resulting in substantially different brain function and affecting everything from learning to the potential for epilepsy. With chapters authored by experts in each topic, this book advances the understanding of: - How the brain carries out important tasks via networks - How these networks interact in normal brain function - Major mechanisms that control network function - The interaction of the normal networks to produce more complex behaviors - How brain disorders can result from abnormal interactions - How therapy of disorders can be advanced through this network approach This book will benefit neuroscience researchers and graduate students with an interest in networks, as well as clinicians in neuroscience, pharmacology, and psychiatry dealing with neurobiological disorders. - Utilizes perspectives and tools from various neuroscience subdisciplines (cellular, systems, physiologic), making the volume broadly relevant - Chapters explore normal network function and control mechanisms, with an eye to improving therapies for brain disorders - Reflects predominant disciplinary shift from an anatomical to a functional perspective of the brain - Edited work with chapters authored by leaders in the field around the globe – the broadest, most expert coverage available