Clinical Trials in Neurology

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 is Director of the Cleveland Clinic Lou Ruvo Center for Brain Health in Nevada, Ohio and Florida, USA. Michael McDermott is Professor of Biostatistics and Professor of Neurology at the University of Rochester School of Medicine, New York, USA. Michael Poole is Chief Medical Officer of Link Medicine, Cambridge, Massachusetts, USA.

• 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.