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Clinical trials in the neurosciences

K. M Woodbury-Harris (Katherine M.); B. M Coull (Bruce M.)

Basel Karger New York 2009

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  • Título:
    Clinical trials in the neurosciences
  • Autor: K. M Woodbury-Harris (Katherine M.); B. M Coull (Bruce M.)
  • Assuntos: Neurology -- Research; Neurosciences -- Research; Clinical trials; Neurology -- methods; Clinical Trials as Topic; Nervous System Diseases; NEUROCIÊNCIAS; NEUROLOGIA; DOENÇAS DO SISTEMA NERVOSO; Neurosurgical Procedures; Research Design; Interventions neurochirurgicales; Projet recherche
  • Notas: Includes bibliographical references and indexes.
  • Descrição: Evolution of clinical trials in neurology -- Preclinical tools -- Translation -- Role of animal studies in the design of clinical trials -- STAIR -- Translating interventions from ischemic stroke models to patients: the view in 2009 -- Pharmacology -- Scaling up from animal to human studies -- FDA requirements for preclinial studies -- Clinical tools -- Pilot trials -- Phase I/II: design and analysis -- Biomarkers in neurology -- Randomized, blinded trial -- FDA investigational new drug requirements -- European Union regulatory requirements -- Adaptive clinical trials -- Design and analysis plans -- Behavioral/neuropsychological outcomes and quality of life endpoints -- Clinical endpoints -- Data management and quality assurance -- Multicentered trials -- Multidisciplinary trial design -- Design and analysis issues -- Strategies for recruiting and retaining minorities -- Informed consent and HIPAA -- Committees for multicenter clinical trials -- Interim monitoring of clinical trials -- Medical monitoring -- Budgets for clinical trials -- Institutional review boards and ethical issues in randomized clinical trials -- Financial conflict of interest -- Special populations and genetic studies -- Clinical trials in progressive neurological diseases -- Genetics in clinical trials -- Randomized clinical trials in children -- Neurological emergencies -- Clinical trials of surgical devices for neurological disorders -- Gene therapy clinical trials in the human brain -- Imaging -- Magnetic resonance imaging for surrogate outcomes and patient selection -- Computed tomography -- Positron emission tomography imaging -- Training and education -- Clinical research training opportunities and elements.
  • Editor: Basel Karger New York
  • Data de criação/publicação: 2009
  • Formato: xii, 213 pages illustrations 27 cm.
  • Idioma: Inglês
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  • Realização: ABCD-USP USP   Logos de Redes Sociais: Freepik

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