Clinical Trials in Neurology

"This much needed book is a gem. If you are involved in a clinical trial make sure you and all your collaborators have read it, before the trial commences...This book provides the information the clinician needs to understand how trials are organised, how data are collected, how they are analysed, and how their clinical significance should be assessed. Dr Guiloff has assembled an impressive team of contributors, all with expertise and experience in their subject. "The consistent high quality of [the] chapters is remarkable in a multiauthored text and a tribute to the hard work of the editor. The book concludes with a review by Michael Brooke that should be required reading for every neurologist. This book not only fills a gap on the neurologist's bookshelf but also will be opened again and again" -Michael Swash

• 1 Ethical Considerations.- 2 Assessment Measures and Clinical Scales.- 3 Ethics, Outcome Variables and Clinical Scales: The Clinician’s Point of View.- 4 The Cochrane Collaboration Reviews in Neurology.- 5 Drug Development Stages.- 6 Drug Regulatory Requirements in the United Kingdom and Europe.- 7 Drug Regulatory Requirements in the United States.- 8 Quality Control and Data Monitoring: A Guide To Good Clinical Practice.- 9 Statistical Issues in Clinical Trials in Neurology.- 10 Analysis of Results: Statistical Principles.- 11 Survival Analysis.- 12 The Intention-to-Treat Principle for Clinical Trials.- 13 Statistical Analysis of Repeated-Measures Data with Drop-outs.- 14 The Role of Meta-analyses in Clinical Research: Uses and Limitations.- 15 Outcome Variables in Dementia Trials: Conceptual and Practical Issues.- 16 Dementia: Trial Design and Experience with Large Multicentre Trials.- 17 Cerebrovascular Disease: Basic Designs, Sample Sizes and Pitfalls.- 18 Clinical Trials in Stroke Prevention in North America.- 19 Cerebrovascular Disease: Experience Within Large Multicentre Trials.- 20 Epilepsy: Ethics, Outcome Variables and Clinical Scales.- 21 Epilepsy: Basic Designs, Sample Sizes and Experience with Large Multicentre Trials.- 22 Headache: Ethics, Outcome Variables and Clinical Studies.- 23 Headache: Basic Trial Designs, Sample Sizes and Pitfalls.- 24 Headache: Experience with Large Multicenter Trials in the Treatment of Migraine Attacks.- 25 Parkinson’s Disease: Outcome Variables and Clinical Scales.- 26 Parkinson’s Disease: A Review of Drug Trials.- 27 Parkinson’s Disease: Experience with Large Multicentre Trials.- 28 Tremor: Clinical Measurement of Impairment, Disability and Handicap.- 29 Tremor: Natural Behaviour, Trial Design and Physiological OutcomeMeasures.- 30 Multiple Sclerosis: Ethics, Outcome Variables and Clinical Scales.- 31 Multiple Sclerosis: Study Design, Sample Sizes and Pitfalls.- 32 Multiple Sclerosis: Experience with Large Clinical Trials.- 33 Motor Neurone Disease: Ethics, Outcome Variables and Clinical Scales.- 34 Motor Neurone Disease: Basic Designs, Sample Sizes and Pitfalls.- 35 Motor Neurone Disease: Experience with Large Multicentre Trials.- 36 Peripheral Neuropathies: Controlled Clinical Trials.- 37 Peripheral Neuropathies: Experience with Large Multicentre Trials.- 38 Disorders of the Neuromuscular Junction: Outcome Measures and Clinical Scales.- 39 Myasthenia Gravis: Basic Designs, Sample Sizes and Pitfalls.- 40 Myopathies: Ethics, Outcome Variables and Clinical Scales.- 41 Myopathies: Basic Designs, Sample Sizes and Pitfalls.