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Title Clinical trials in the neurosciences / volume editors, K.M. Woodbury-Harris, B.M. Coull
Published Basel ; New York : Karger, ©2009


Description 1 online resource (xii, 213 pages) : illustrations
Series Frontiers of neurology and neuroscience, 1660-4431 ; v. 25
Frontiers of neurology and neuroscience ; v. 25.
Contents Cover; Contents; List of Contributors; Introduction; Evolution of Clinical Trials in Neurology; Pragmatic Adjustment to Changing Practice Pattern; Conceptual Innovation of Clinical Trials; Practical Issues for Future Protocols; References; Preclinical Trials; Translation; Role of Animal Studies in the Design of Clinical Trials; Goals of Drug Therapies for Acute Neurological Disorders; Acute Neurological Injury Models; What Have Previous Clinical Trials of Neuroprotective Agents Taught Us about the Needs for Preclinical Drug Evaluation in Animal Models?
Issues that Need to Be Addressed in Preclinical Neuroprotective or Neurorestorative Drug EvaluationGene and Cellular Therapies; Utility of Transgenic and Gene Knockout Models for Preclinical Therapeutic Evaluation; Outcome Measures in Preclinical Models; Restrictions and Ethical Considerations in Animal Studies; Summary; References; STAIR; Translating Interventions from Ischemic Stroke Models to Patients: The View in 2009; Modeling Considerations by the STAIR Initiative; Another Look at the Problem of Translating Stroke from Animal Models to Humans; References; Pharmacology
Scaling Up from Animal to Human StudiesPreclinical Phase; Phase I; Phase II; Phase III; Statistical Approaches; Study Logistics; References; FDA Requirements for Preclinical Studies; Clinical Trials; Pilot Trials; Phase I/II -- Design and Analysis; Biomarkers in Neurology; Pitfalls in Choosing Biomarkers; Biomarkers in Neurodegenerative Diseases; Biomarkers and Stroke; Conclusion; References; The Randomized, Blinded Trial; FDA Investigational New Drug Requirements; European Union Regulatory Requirements; Legislation Governing Clinical Trials Evaluating Medicinal Products in the European Union
An Overview of the EU CTDKey Directives, Guidance Documents and Instructions for Application to CA and EC; Challenges in the Implementation of the CTD and Future Directions; Disclaimer; References; Adaptive Clinical Trials; Sample Size Re-Estimation; Adaptive Seamless Phase II/III Trials; Challenges in Adaptive Designs; References; Design and Analysis Plans; References; Behavioral/Neuropsychological Outcomes and Quality of Life Endpoints; Defining Behavioral Outcome; Choosing a Test Battery; Testing Standards; Test Selection; Language; Visuospatial Functions; Attention, Vigilance and Tracking
Memory and LearningExecutive Functions; Motor/Psychomotor Skills; Measuring Quality of Life; Computerized Assessment of Neuropsychological Function; Study Participants; Testing Considerations; Burden of Neuropsychological Testing on Recruitment and Retention; References; Clinical Endpoints; Classification; Clinical Outcome Scales; Health-Related Quality of Life; The Need for Patient-Reported Outcomes; Patient-Reported Outcomes Measurement Information System; Conclusion; References; Data Management and Quality Assurance; Data Management Team; Data Management Plan
Summary 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
Bibliography Includes bibliographical references and indexes
Notes Print version record
Subject Neurology -- Research.
Neurosciences -- Research
Clinical trials.
Nervous system -- Diseases.
Nervous system -- Surgery.
Clinical Trials as Topic
Neurology -- methods
Nervous System Diseases
Neurosurgical Procedures
Research Design
HEALTH & FITNESS -- Diseases -- Nervous System (incl. Brain)
MEDICAL -- Neurology.
Nervous system -- Surgery
Nervous system -- Diseases
Clinical trials
Neurology -- Research
Neurosciences -- Research
Essais cliniques comme sujet.
Interventions neurochirurgicales.
Projet recherche.
Neurologie -- Recherche.
Neurosciences -- Recherche.
√Čtudes cliniques.
Klinisches Experiment -- Neurologie -- Aufsatzsammlung.
Neurologie -- Klinisches Experiment -- Aufsatzsammlung.
Form Electronic book
Author Woodbury-Harris, K. M. (Katherine M.)
Coull, B. M. (Bruce M.)
ISBN 9783805590242