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Author: Katherine M. Woodbury-Harris
Publisher:
ISBN: 9783805590242
Category : Clinical Trials as Topic
Languages : en
Pages : 0
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Book Description
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.
Author: Katherine M. Woodbury-Harris
Publisher:
ISBN: 9783805590242
Category : Clinical Trials as Topic
Languages : en
Pages : 0
Get Book
Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309442583
Category : Medical
Languages : en
Pages : 111
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Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309442559
Category : Medical
Languages : en
Pages : 111
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Book Description
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.
Author: Bernard Ravina
Publisher: Cambridge University Press
ISBN: 0521762596
Category : Medical
Languages : en
Pages : 387
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Book Description
Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences.
Author: Roberto J. Guiloff
Publisher: Springer Science & Business Media
ISBN: 1447137876
Category : Medical
Languages : en
Pages : 537
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Book Description
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.
Author: Roger J. Porter
Publisher: Springer
ISBN: 9781461288046
Category : Medical
Languages : en
Pages : 440
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Book Description
The evaluation of the efficacy and safety of a clinical tool, be it a diagnostic technique, a preventive methodology, or a therapeutic intervention, is an im portant responsibility of physicians. The history of medicine is characterized by the authoritarianisms of teachers and of organizations giving way to the clinical experience of physicians; authoritarian dictum was replaced by case report and then by case series. As physicians learned to substitute the analysis of data for the inconsistencies of dictums and anecdotes, the problems of the case series as an investigative tool became more evident: patient selection criteria, measurements of outcome, significance of results, and extrapolation of conclusions to the community of patients. In response to these issues, the methodology of the controlled clinical trial has evolved and with it the instru ments of study design and of biostatistics as aids to study design and data analysis. The medical - surgical armamentarium has evolved from being dependent solely upon the observations and conclusions of a skilled clinician to being constructed upon the systematic collection and evaluation of data by a team of skilled clinicians and their statistical colleagues: this is the controlled clinical trial. During the past two decades, the evaluation of clinical approaches to pre vention and therapy has become particularly important to clinicians concerned with nervous system dysfunction. There has been and continues to be an explosion of information from the basic neurosciences and from the applica tion of biotechnology to the nervous system.
Author: Karen Kaplan-Solms
Publisher: Routledge
ISBN: 0429911998
Category : Psychology
Languages : en
Pages : 336
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Book Description
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.
Author: Brett E. Skolnick
Publisher: Academic Press
ISBN: 0128041013
Category : Science
Languages : en
Pages : 400
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Book Description
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
Author: K. M. Woodbury-Harris
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Author: Wayne M. Alves
Publisher: Elsevier
ISBN: 9780080454351
Category : Science
Languages : en
Pages : 360
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Book Description
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
