Clinical Trials in Neurology: Design, Conduct, Analysis

Cambridge University Press, 4/12/2012
EAN 9780521762595, ISBN10: 0521762596

Hardcover, 386 pages, 25.2 x 19.3 x 2.1 cm
Language: English

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.

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.