Clinical trials in the neurosciences 15 tables

 Content: 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.