Download or read book Clinical Trials in the Neurosciences written by Katherine M. Woodbury-Harris and published by . This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: A properly designed and executed clinical trial that addresses an import question and delivers a definitive result can change the practice of medicine worldwide. This book encompasses a bench-to-bedside approach and serves as an excellent guidance for translating preclinical studies to early phase I/II and phase III trials. In the first part, the book covers preclinical science with respect to animal models of various neurological diseases, FDA requirements for preclinical studies, translation of animal to patient studies and scaling up from animal to human studies. In the second part, the design of phase I/II trials and the use of biomarkers as surrogate endpoints are discussed. With regard to phase III trials, FDA and European requirements, specific design issues, relevant clinical endpoints as well as data management and quality are examined. Topics specific to multicenter trials, such as design, recruitment of special populations, monitoring, ethical and consent issues are also covered. Finally, genetics, gene therapy, imaging and surgical devices are reviewed. This publication is highly recommended to clinician researchers, such as neurologists, neurosurgeons, pediatric neurologists and neonatologists, who want to design and conduct clinical trials in the neuroscience, but also to nurses, research coordinators and clinical pharmacologists.
Download or read book Neuroscience Trials of the Future written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-11-07 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Neuroscience Trials of the Future written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-12-07 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Clinical Trials in Neurology written by Bernard Ravina and published by Cambridge University Press. This book was released on 2012-04-12 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences.
Download or read book Clinical Studies in Neuro psychoanalysis written by Karen Kaplan-Solms and published by Routledge. This book was released on 2018-06-14 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: When the first edition of Clinical studies in Neuro-Psychoanalysis was published in 2000, it was hailed as a turning point in psychoanalytic research. It is now relied on as a model for the integration of neuroscience and psychoanalysis. It won the NAAP's Gradiva Award for Best Book of the Year 2000 (Science Category) and Mark Solms received the International Psychiatrist Award 2001 at the American Psychiatric Association's annual meeting. The authors have added a glossary of key terms of this edition to aid their introduction to depth neuropsychology. 'Freud, in his 1895 Project for a Scientific Psychology, attempted to join the emerging discipline of psychoanalysis with the neuroscience of his time. But that was a hundred years ago, when the neuron had only just been described, and Freud was forced - through lack of pertinent knowledge - to abandon his project. We have had to wait many decades before the sort of data which Freud needed finally became available. Now, these many years later, contemporary neuroscience allows for the resumption of the search for correlations between these two disciplines.
Download or read book Clinical Trials in Neurology written by Roberto J. Guiloff and published by Springer Science & Business Media. This book was released on 2013-03-14 with total page 537 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials in Neurology comprehensively tackles the methodology and design of clinical trials in neurological disease. A general section deals with the ethical aspects, drug development and regulatory requirements, basic trial designs and the statistics used. A diseases section tackles specific aspects of disorders, focusing on the relevant ethical issues, outcome variables and experience with large multicentre trials.
Download or read book Controlled Clinical Trials in Neurological Disease written by Roger J Porter and published by . This book was released on 1990-05-31 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook of Neuroemergency Clinical Trials written by Brett E. Skolnick and published by Academic Press. This book was released on 2017-11-13 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. This volume provides neurologists, neuroscientists, and drug developers with a more complete understanding of the scientific and medical issues of relevance in designing and initiating clinical development plans for novel drugs intended for acute neuroscience populations. The editors provide the best understanding of the pitfalls associated with acute CNS drug development and the best information on how to approach and solve issues that have plagued drug development. Presents a comprehensive overview on clinical trials and drug development challenges in acute neuroscience populations Provides neurologists, neuroscientists and drug developers with a complete understanding of scientific and medical issues related to designing clinical trials Edited by leaders in the field who have designed and managed over 50 neuroemergency clinical trials
Download or read book Clinical Trials in Neuroscience written by K. M. Woodbury-Harris and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook of Neuroemergency Clinical Trials written by Wayne M. Alves and published by Elsevier. This book was released on 2006-01-18 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the 1990’s, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. Numerous novel compounds were “tested, and seemingly fell by the wayside. This book is intended to focus on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. The authors explore the issues facing research in this area and the strategies that might lead to future success in this critical area of unmet medical need. It represents a compendium of information gained from over 20 years of clinical trial experience in areas of acute neurology and neurosurgery. From the knowledge of clinical assessment using standardized tools, to the intricate design of difficult hyper-acute neuroemergencies trials, the reader will benefit from the authors’ perspectives. * Presents new perspectives on acute neuroemergency clinical trials * Includes insights from clinical pharmacology and industry perspectives * Discusses historical lessons learned from early and recent trials in acute neuroscience populations
Download or read book Clinical Trials in Neurology written by Bernard Ravina and published by . This book was released on 2012 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences.
Download or read book 50 Studies Every Neurologist Should Know written by David Y. Hwang and published by Oxford University Press. This book was released on 2016-04-13 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: 50 Studies Every Neurologist Should Know presents key studies that shape the current clinical practice of neurology. All neurologic subspecialties are covered, with a special emphasis on neurocritical care and vascular neurology. For each study, a concise summary is presented with an emphasis on the results and limitations of the study, and its implications for practice. An illustrative clinical case concludes each review, followed by brief information on other relevant studies. This is the first book of its kind to present a collection of the most influential clinical trials in neurology that are detailed enough to be used on rounds, but still easily digestible. It is a must-read for health care professionals and anyone who wants to learn more about the data behind clinical practice.
Download or read book Neuroscience Biomarkers and Biosignatures written by Institute of Medicine and published by National Academies Press. This book was released on 2008-01-08 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book 50 Studies Every Neurologist Should Know written by David Y. Hwang and published by Oxford University Press. This book was released on 2016 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: '50 Studies Every Neurologist Should Know' presents summaries and analyses of clinical trials that have shaped the current practice of neurology. Every subspecialty is covered, with special emphasis on neurocritical care and vascular neurology.
Download or read book Global Clinical Trials for Alzheimer s Disease written by Menghis Bairu and published by Academic Press. This book was released on 2013-08-28 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease. Written by leading experts with hands-on experience in designing and running global Alzheimer’s disease and other neurodegenerative diseases clinical trials A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer’s disease global clinical trials in emerging markets and developing countries
Download or read book Clinical Trials in Neurologic Practice written by José Biller and published by Butterworth-Heinemann. This book was released on 2001 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text covers the neurologic areas where trials have become increasingly important, including stroke, epilepsy, head and spinal cord injuries, and movement disorders. By applying the clinical evidence gained from the trials to neurologic practice, clinicians will be better positioned to meet the needs of their patients. * A practical approach to assist neurologists and neurologists in training in the understanding of clinical trials for neurologic disorders * Authors have assembled a distinguished international group of contributors to critically evaluate trials that have been conducted in their areas of expertise * Ideal book for practitioners interested in evidence-based neurologic practice
