Clinical Trials in Neuroscience

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März 2009



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.


Introduction: Coull, B.M.; Woodbury-Harris, K.M. Evolution of Clinical Trials in Neurology: Stapf, C.; Preclinical Trials; Translation; Role of Animal Studies in the Design of Clinical Trials: Hall, E.D.; Traystman, R.J.; STAIR; Translating Interventions from Ischemic Stroke; Models to Patients: The View in 2009: del Zoppo, G.J.; Moskowitz, M.A.; Pharmacology; Scaling Up from Animal to Human Studies: Hemmen, T.M; Zivin, J.; FDA Requirements for Preclinical Studies: McElvany, K.D.; Clinical Trials; Pilot Trials; Phase I/II - Design and Analysis: Coleman, W.P.; Woodbury-Harris, K.M.; Coull, B.M. Biomarkers in Neurology: Silva, G.; Furie, K.; The Randomized, Blinded Trial; FDA Investigational New Drug Requirements: McElvany, K.D.; European Union Regulatory Requirements: Radziszewska, B.; Adaptive Clinical Trials: Gilbert, P.R.; Design and Analysis Plans: Palesch, Y.Y.; Behavioral/Neuropsychological Outcomes and Quality of Life Endpoints: Levin, B.E.; Clinical Endpoints: Sonni, S.; Furie, K.; Data Management and Quality Assurance: Richardson, D.; Kunitz, S.C.; Multicentered Trials; Multidisciplinary Trial Design: Stapf, C. Design and Analysis Issues: Coleman, W.P.; Strategies for Recruiting and Retaining Minorities: DeBaun, M.R.; Gorelick, P.B.; Som, S. Informed Consent and HIPAA: Woodbury-Harris, K.M.; Committees for Multicenter Clinical Trials: Adams, H.P., Jr.; Interim Monitoring of Clinical Trials: Richardson, D. Medical Monitoring: Adams, H.P., Jr.; Budgets for Clinical Trials: Kelly, L.C.; Hart, R.G.; Institutional Review Boards and Ethical Issues in Randomized Clinical Trials: Shinnar, S.; Financial Conflict of Interest: Fureman, B.E.; Special Populations and Genetic Studies; Clinical Trials in Progressive Neurological Diseases. Recruitment, Enrollment, Retention and Compliance: Bedlack, R.S.; Cudkowicz, M.E.; Genetics in Clinical Trials: Meschia, J.F.; Gwinn, K.; Randomized Clinical Trials in Children: Ment, L.R.; Shinnar, S.; Neurological Emergencies: Silbergleit, R.; Barsan, W.; Clinical Trials of Surgical Devices for Neurological Disorders: Kaplitt, M.G.; Barbaro, N.; Gene Therapy Clinical Trials in the Human Brain. Protocol Development and Review of Current Applications: Kaplitt, M.G.; Imaging; Magnetic Resonance Imaging for Surrogate Outcomes and Patient Selection: Hsia, A.W.; Kidwell, C.S.; Computed Tomography: Lima, F.; Goldmakher, G.; Lev, M.; Furie, K.; Positron Emission Tomography Imaging: Dhawan, V.; Eidelberg, D.; Training and Education Clinical Research Training Opportunities and Elements: Franz, D.; Coull, B.M.; Appendix.
EAN: 9783805590235
ISBN: 3805590237
Untertitel: 'Frontiers of Neurology and Neuroscience'. Tables:15. Sprache: Englisch.
Verlag: Karger Verlag
Erscheinungsdatum: März 2009
Seitenanzahl: 214 Seiten
Format: gebunden
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