Clinical Trials in Neurology (eBook, PDF)

Design, Conduct, Analysis
Redaktion: Ravina, Bernard

• Format: PDF

Produktbeschreibung

Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.

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Produktdetails

• Verlag: Cambridge University Press
• Erscheinungstermin: 12. April 2012
• Englisch
• ISBN-13: 9781139368308
• Artikelnr.: 38277935

Inhaltsangabe

Preface; Part I. The Role of Clinical Trials in Therapy Development: 1. The
impact of clinical trials in neurology E. Ray Dorsey and S. Claiborne
Johnston; 2. The sequence of clinical development Michael Poole; 3. Unique
challenges in the development of therapies for neurological disorders
Gilmore N. O'Neill; Part II. Concepts in Biostatistics and Clinical
Measurement: 4. Fundamentals of biostatistics Judith Bebchuk and Janet
Wittes; 5. Bias and random error Susan S. Ellenberg and Jacqueline A.
French; 6. Approaches to data analysis William R. Clarke; 7. Selecting
outcome measures Robert G. Holloway and Andrew D. Siderowf; Part III.
Special Study Designs and Methods for Data Monitoring: 8. Selection and
futility designs Bruce Levin; 9. Adaptive designs across stages of
therapeutic development Christopher S. Coffey; 10. Crossover designs Mary
E. Putt; 11. Two period designs for evaluation of disease-modifying
treatments Michael P. McDermott; 12. Enrichment designs Kathryn M. Kellogg
and John Markman; 13. Non-inferiority trials Rick Chappell; 14. Monitoring
of clinical trials: interim monitoring, data monitoring committees, and
group sequential methods applied to neurology Rickey E. Carter and Robert
F. Woolson; 15. Clinical approaches to post-marketing drug safety
assessment Gerald J. Dal Pan; Part IV. Ethical Issues: 16. Ethics in
clinical trials involving the central nervous system: risk, benefit,
justice, and integrity Jonathan Kimmelman; 17. The informed consent
process: compliance and beyond Scott Y. H. Kim; Part V. Regulatory
Perspectives: 18. Evidentiary standards for neurologic drugs and biologics
approval Russell Katz; 19. Premarket reviews of neurological devices Eric
A. Mann and Peter G. Como; Part VI. Clinical Trials in Common Neurological
Disorders: 20. Parkinson's disease Karl D. Kieburtz and Jordan Elm; 21.
Alzheimer's disease Joshua Grill and Jeffrey Cummings; 22. Acute ischemic
stroke Karen C. Johnston, Devin L. Brown and Yuko Y. Palesch; 23. Multiple
sclerosis Richard A. Rudick, Elizabeth Fisher and Gary R. Cutter; 24.
Amytrophic lateral sclerosis (ALS) Nazem Atassi, David Schoenfeld and Merit
Cudkowicz; 25. Epilepsy John R. Pollard, Susan S. Ellenberg and Jacqueline
A. French; 26. Insomnia Michael E. Yurcheshen, Changyong Feng and J. Todd
Arnedt; Part VII. Clinical Trial Planning and Implementation: 27. Clinical
trial planning: an academic and industry perspective Cornelia L. Kamp and
Jean-Michel Germain; 28. Clinical trial implementation, analysis and
reporting: an academic and industry perspective Cornelia L. Kamp and
Jean-Michel Germain; 29. Academic-industry collaborations and compliance
issues Troy Morgan; Index.