Clinical Trials in Neurology de Bernard Ravina MD MSCE

Clinical Trials in Neurology: Design, Conduct, Analysis

Bernard Ravina MD MSCE

Jeffrey Cummings

Michael McDermott

R. Michael Poole

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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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.