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Clinical Trials in the Neurosciences Frontiers of Neurology and Neuroscience 1st Edition by Woodbury harris, Coull 3805590237 9783805590235

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Clinical Trials in the Neurosciences Frontiers of Neurology and Neuroscience 1st Edition K. M. Woodbury-Harris Digital Instant Download

Author(s): K. M. Woodbury-harris, B. M. Coull
ISBN(s): 9783805590235, 3805590237
Edition: 1
File Details: PDF, 1.86 MB
Year: 2009
Language: english
SKU: EB-1462270 Category: Tags: ,

Clinical Trials in the Neurosciences Frontiers of Neurology and Neuroscience 1st Edition by Woodbury harris, Coull – Ebook PDF Instant Download/Delivery: 3805590237, 9783805590235

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ISBN 10: 3805590237

ISBN 13: 9783805590235

Author: K. M. Woodbury-harris, B. M. Coull

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

Clinical Trials in the Neurosciences Frontiers of Neurology and Neuroscience 1st Table of contents:

I – XII: Title Page / Table of Contents / List of Contributors
1 – 3: Introduction
4 – 8: Evolution of Clinical Trials in Neurology
10 – 33: Role of Animal Studies in the Design of Clinical Trials
34 – 38: Translating Interventions from Ischemic Stroke Models to Patients: The View in 2009
39 – 45: Scaling Up from Animal to Human Studies
46 – 49: FDA Requirements for Preclinical Studies
52 – 54: Phase I/II – Design and Analysis
55 – 61: Biomarkers in Neurology
62 – 65: FDA Investigational New Drug Requirements
66 – 70: European Union Regulatory Requirements
71 – 75: Adaptive Clinical Trials
76 – 77: Design and Analysis Plans
78 – 92: Behavioral/Neuropsychological Outcomes and Quality of Life Endpoints
93 – 97: Clinical Endpoints
98 – 105: Data Management and Quality Assurance
106 – 113: Multidisciplinary Trial Design
114 – 117: Design and Analysis Issues
118 – 120: Strategies for Recruiting and Retaining Minorities
121 – 123: Informed Consent and HIPAA
124 – 126: Committees for Multicenter Clinical Trials
127 – 130: Interim Monitoring of Clinical Trials
131 – 132: Medical Monitoring
133 – 135: Budgets for Clinical Trials
136 – 140: Institutional Review Boards and Ethical Issues in Randomized Clinical Trials
141 – 143: Financial Conflict of Interest
144 – 151: Clinical Trials in Progressive Neurological Diseases: Recruitment, Enrollment, Retention and Compliance
152 – 157: Genetics in Clinical Trials
158 – 162: Randomized Clinical Trials in Children
163 – 173: Neurological Emergencies
174 – 179: Clinical Trials of Surgical Devices for Neurological Disorders
180 – 188: Gene Therapy Clinical Trials in the Human Brain: Protocol Development and Review of Current Applications
189 – 192: Magnetic Resonance Imaging for Surrogate Outcomes and Patient Selection
193 – 196: Computed Tomography
197 – 202: Positron Emission Tomography Imaging
203 – 205: Clinical Research Training Opportunities and Elements

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Woodbury harris,Coull,Clinical,Neurosciences