Commonalities and Challenges in the Development of Clinical Trial Measures in Neurology

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• 作者：Jesse M. Cedarbaum (1)
  Diane Stephenson (2)
  Richard Rudick (3)
  Maria C. Carrillo (4)
  Glenn Stebbins (5)
  Douglas Kerr (6)
  Jill Heemskerk (7)
  Wendy R. Galpern (8)
  Petra Kaufmann (9)
  David Cella (10)
  Maria Isaac (11)
  Marc K. Walton (12)
  
  1. Neurology Early Clinical Development ; Biogen Idec ; 14 Cambridge Center ; Cambridge ; MA ; 02142 ; USA
  2. Coalition Against Major Diseases ; Critical Path Institute ; Tucson ; AZ ; USA
  3. Value Based Medicine ; Biogen Idec ; Cambridge ; MA ; USA
  4. Medical & Scientific Relations ; Alzheimer鈥檚 Association ; Chicago ; IL ; USA
  5. Department of Neurological Sciences ; Rush University Medical Center ; Chicago ; IL ; USA
  6. Clinical and Safety Sciences ; Biogen Idec ; Cambridge ; MA ; USA
  7. Division of Adult Translational Research ; National Institute of Mental Health ; National Institutes of Health ; Bethesda ; MD ; USA
  8. Office of Clinical Research ; National Institute of Neurological Disorders and Stroke ; Bethesda ; MD ; USA
  9. Division of Clinical Innovation ; National Center for Advancing Translational Sciences ; National Institutes of Health ; Bethesda ; MD ; USA
  10. Northwestern University Feinberg School of Medicine ; Chicago ; IL ; USA
  11. European Medicines Agency ; London ; UK
  12. Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration ; Silver Spring ; MD ; USA
  
• 关键词：Clinical trials ; Clinical outcome assessments
• 刊名：Neurotherapeutics
• 出版年：2015
• 出版时间：January 2015
• 年：2015
• 卷：12
• 期：1
• 页码：151-169
• 全文大小：1,608 KB
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• 刊物主题：Neurosciences; Neurology; Neurosurgery; Neurobiology;
• 出版者：Springer US
• ISSN：1878-7479

文摘

As neurologists and neuroscientists, we are trained to evaluate disorders of the nervous system by thinking systematically. Clinically, we think in terms of cognition, behavior, motor function, sensation, balance and co-ordination, and autonomic system function. But when we assess symptoms of neurological disorders for the purpose of drug development, we tend to create disease-specific outcome measures, often using a variety of methods to assess the same types of dysfunction in overlapping, related disorders. To begin to explore the potential to simplify and harmonize the assessment of dysfunction across neurological disorders, a symposium, entitled, "Commonalities in the Development of Outcome Measures in Neurology" was held at the 16th annual meeting of the American Society for Experimental NeuroTherapeutics (ASENT), in February 2014. This paper summarizes the presentations at the symposium. The authors hope that readers will begin to view Clinical Outcome Assessment (COA) development in a new light. We hope that in presenting this material, we will stimulate discussions and collaborations across disease areas to develop common concepts of neurological COA development and construction.