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Author: Bernard Ravina
Publisher: Cambridge University Press
ISBN: 1107376572
Category : Medical
Languages : en
Pages : 387
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Book Description
Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.
Author: Bernard Ravina
Publisher: Cambridge University Press
ISBN: 1107376572
Category : Medical
Languages : en
Pages : 387
Get Book
Book Description
Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.
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: 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: 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: Roger J. Porter
Publisher: Springer Science & Business Media
ISBN: 146131495X
Category : Medical
Languages : en
Pages : 447
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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: Katherine M. Woodbury-Harris
Publisher: Karger Medical and Scientific Publishers
ISBN: 3805590237
Category : Medical
Languages : en
Pages : 225
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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: David Y. Hwang
Publisher: Oxford University Press
ISBN: 0199377537
Category : Medical
Languages : en
Pages : 352
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Book Description
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.
Author: E. Beghi
Publisher: Karger Medical and Scientific Publishers
ISBN: 3318058653
Category : Medical
Languages : en
Pages : 168
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Book Description
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.
Author: David Y. Hwang
Publisher: Oxford University Press
ISBN: 0199377529
Category : Medical
Languages : en
Pages : 378
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Book Description
'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.
Author: José Biller
Publisher: Butterworth-Heinemann
ISBN:
Category : Medical
Languages : en
Pages : 378
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Book Description
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
