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1 Ethical Considerations 3
2 Assessment Measures and Clinical Scales 17
3 Ethics, Outcome Variables and Clinical Scales: The Clinician's Point of View 29
4 The Cochrane Collaboration Reviews in Neurology 43
5 Drug Development Stages 53
6 Drug Regulatory Requirements in the United Kingdom and Europe 59
7 Drug Regulatory Requirements in the United States 71
8 Quality Control and Data Monitoring: A Guide To Good Clinical Practice 81
9 Statistical Issues in Clinical Trials in Neurology 95
10 Analysis of Results: Statistical Principles 105
11 Survival Analysis 121
12 The Intention-to-Treat Principle for Clinical Trials 131
13 Statistical Analysis of Repeated-Measures Data with Drop-outs 145
14 The Role of Meta-analyses in Clinical Research: Uses and Limitations 157
15 Outcome Variables in Dementia Trials: Conceptual and Practical Issues 171
16 Dementia: Trial Design and Experience with Large Multicentre Trials 183
17 Cerebrovascular Disease: Basic Designs, Sample Sizes and Pitfalls 199
18 Clinical Trials in Stroke Prevention in North America 213
19 Cerebrovascular Disease: Experience Within Large Multicentre Trials 229
20 Epilepsy: Ethics, Outcome Variables and Clinical Scales 251
21 Epilepsy: Basic Designs, Sample Sizes and Experience with Large Multicentre Trials 261
22 Headache: Ethics, Outcome Variables and Clinical Studies 271
23 Headache: Basic Trial Designs, Sample Sizes and Pitfalls 279
24 Headache: Experience with Large Multicenter Trials in the Treatment of Migraine Attacks 291
25 Parkinson's Disease: Outcome Variables and Clinical Scales 299
26 Parkinson's Disease: A Review of Drug Trials 311
27 Parkinson's Disease: Experience with Large Multicentre Trials 325
28 Tremor: Clinical Measurement of Impairment, Disability and Handicap 339
29 Tremor: Natural Behaviour, Trial Design and Physiological Outcome Measures 347
30 Multiple Sclerosis: Ethics, Outcome Variables and Clinical Scales 359
31 Multiple Sclerosis: Study Design, Sample Sizes and Pitfalls 371
32 Multiple Sclerosis: Experience with Large Clinical Trials 387
33 Motor Neurone Disease: Ethics, Outcome Variables and Clinical Scales 403
34 Motor Neurone Disease: Basic Designs, Sample Sizes and Pitfalls 427
35 Motor Neurone Disease: Experience with Large Multicentre Trials 451
36 Peripheral Neuropathies: Controlled Clinical Trials 465
37 Peripheral Neuropathies: Experience with Large Multicentre Trials 479
38 Disorders of the Neuromuscular Junction: Outcome Measures and Clinical Scales 485
39 Myasthenia Gravis: Basic Designs, Sample Sizes and Pitfalls 501
40 Myopathies: Ethics, Outcome Variables and Clinical Scales 505
41 Myopathies: Basic Designs, Sample Sizes and Pitfalls 515
Index 529