Clinical trials in the neurosciences...
Coull, B. M.

 

  • Clinical trials in the neurosciences[electronic resource] /
  • 紀錄類型: 書目-語言資料,印刷品 : Monograph/item
    杜威分類號: 616.80072/4
    書名/作者: Clinical trials in the neurosciences/ volume editors, K.M. Woodbury-Harris, B.M. Coull.
    其他作者: Woodbury-Harris, K. M.
    出版者: Basel : : S. Karger,, 2009
    面頁冊數: 1 online resource : : ill. (some col.)
    附註: A comprehensive and practical overview
    標題: Neurology - Research.
    標題: Neurosciences - Research.
    標題: Clinical trials.
    標題: Clinical Trials as Topic.
    標題: Neurology - methods.
    標題: Nervous System Diseases.
    標題: Neurosurgical Procedures.
    標題: Research Design.
    ISBN: 9783805590242
    書目註: Includes bibliographical references and indexes.
    摘要、提要註: 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.
    電子資源: http://content.karger.com/ProdukteDB/produkte.asp?Aktion=showproducts&searchWhat=books&searchParm=toc&ProduktNr=242160
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