Clinical Trials in Neurology

ISBN-13: 9781852332396 / Angielski / Twarda / 2001 / 542 str.

Roberto J. Guiloff; R. J. Guiloff; Roberto J. Guiloff

Opis

Clinical Trials in Neurology comprehensively tackles the methodology and design of clinical trials in neurological disease. A general section deals with the ethical aspects, drug development and regulatory requirements, basic trial designs and the statistics used. A diseases section tackles specific aspects of disorders, focusing on the relevant ethical issues, outcome variables and experience with large multicentre trials.

Recenzje

"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

Spis treści

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