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Clinical Trials in Neurology
Design, Conduct, Analysis

E. Ray Dorsey, S. Claiborne Johnston, Michael Poole, Gilmore N. O'Neill, Judith Bebchuk, Janet Wittes, Susan S. Ellenberg, Jacqueline A. French, William R. Clarke, Robert G. Holloway, Andrew D. Siderowf, Bruce Levin, Christopher S. Coffey, Mary E. Putt, Michael P. McDermott, Kathryn M. Kellogg, John Markman, Rick Chappell, Rickey E. Carter, Robert F. Woolson, Gerald J. Dal Pan, Jonathan Kimmelman, Scott Y. H. Kim, Russell Katz, Eric A. Mann, Peter G. Como, Karl D. Kieburtz, Jordan Elm, Joshua Grill, Jeffrey Cummings, Karen C. Johnston, Devin L. Brown, Yuko Y. Palesch, Richard A. Rudick, Elizabeth Fisher, Gary R. Cutter, Nazem Atassi, David Schoenfeld, Merit Cudkowicz, John R. Pollard, Michael E. Yurcheshen, Changyong Feng, J. Todd Arnedt, Cornelia L. Kamp, Jean-Michel Germain, Troy Morgan
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  • Date Published: April 2012
  • availability: Available
  • format: Hardback
  • isbn: 9780521762595

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  • 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.

    • Helps readers to understand key regulatory requirements and allows for planning of successful clinical trials
    • Aims to enhance the development of new treatments for neurological diseases
    • Definitive single source of information on neurological clinical trials including the basics of clinical trials design and the issue faced when studying neurologic disorders
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    Product details

    • Date Published: April 2012
    • format: Hardback
    • isbn: 9780521762595
    • length: 386 pages
    • dimensions: 246 x 191 x 23 mm
    • weight: 0.98kg
    • contains: 49 b/w illus.
    • availability: Available
  • Table of Contents

    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.

  • Editors

    Bernard Ravina, Biogen Idec., Cambridge, MA
    Bernard Ravina is Medical Director, Translational Neurology at Biogen Idec in Cambridge, Massachusetts and Adjunct Associate Professor of Neurology at the University of Rochester School of Medicine, New York, USA.

    Jeffrey Cummings, Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas
    Jeffrey Cummings is Director of the Cleveland Clinic Lou Ruvo Center for Brain Health in Nevada, Ohio and Florida, USA.

    Michael McDermott, University of Rochester
    Michael McDermott is Professor of Biostatistics and Professor of Neurology at the University of Rochester School of Medicine, New York, USA.

    R. Michael Poole, AstraZeneca PLC, Waltham, MA, US
    Michael Poole is Chief Medical Officer of Link Medicine, Cambridge, Massachusetts, USA.

    Contributors

    E. Ray Dorsey, S. Claiborne Johnston, Michael Poole, Gilmore N. O'Neill, Judith Bebchuk, Janet Wittes, Susan S. Ellenberg, Jacqueline A. French, William R. Clarke, Robert G. Holloway, Andrew D. Siderowf, Bruce Levin, Christopher S. Coffey, Mary E. Putt, Michael P. McDermott, Kathryn M. Kellogg, John Markman, Rick Chappell, Rickey E. Carter, Robert F. Woolson, Gerald J. Dal Pan, Jonathan Kimmelman, Scott Y. H. Kim, Russell Katz, Eric A. Mann, Peter G. Como, Karl D. Kieburtz, Jordan Elm, Joshua Grill, Jeffrey Cummings, Karen C. Johnston, Devin L. Brown, Yuko Y. Palesch, Richard A. Rudick, Elizabeth Fisher, Gary R. Cutter, Nazem Atassi, David Schoenfeld, Merit Cudkowicz, John R. Pollard, Michael E. Yurcheshen, Changyong Feng, J. Todd Arnedt, Cornelia L. Kamp, Jean-Michel Germain, Troy Morgan

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