Description |
1 online resource (388 pages) |
Series |
Cambridge medicine |
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Cambridge medicine (Series)
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Contents |
Cover; Clinical Trials in Neurology: Design, Conduct, Analysis; Title; Copyright; Dedication; Contents; Contributors; Preface; Audience; Organization and terminology; Disclaimer; Acknowledgements; Section 1: The role of clinical trials in therapy development; Chapter 1: The impact of clinical trials in neurology; Overview; The burden of neurological disease is growing globally; Clinical investigations can have a substantial public health impact; Developing new and novel drugs is increasingly difficult; Developing neurotherapeutics has its own set of challenges |
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Identifying and creating compounds with optimal CNS pharmaceutical propertiesHow can biomarkers and CNS exposure measurements mitigate the risks of CNS drugdevelopment?; Biomarkers; Measuring CNS exposure and target engagement; Measuring biological effects of a therapeutic; Conclusions; References; Section 2: Concepts in biostatistics and clinical measurement; Chapter 4: Fundamentals of biostatistics; Statistical formulation of clinicalquestions; General principles of the design of controlled clinical trials; Primary outcome; Secondary and exploratory outcomes; Study population |
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Non-compliance and dropoutRandom error; Operations manual and training; Data entry and audit; Centralization of operations; Case report forms; On-site monitoring; Analysis of study data; Bias; Intention-to-treat; Eligibility assessment; Random error; Stratification factors; Adjustment for covariates; Interpretation of study results; Bias; The multiple comparisons problem; Subsets; Interim analyses; Methods to account for multiple comparisons; Pre-specification of analytical plan; Random error; Summary; References; Some useful population distributions; The normal and t distributions |
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Reference populationProjected timeline; Control group; Basic statistics for randomized clinical trials; Null and alternative hypotheses; The type I error, or 'a-level'; The type II error, or 'ß-level'; Statistical tests of significance; Sample size; Power; The p-value; Censoring; Log-rank test; Sample size formulae; Other considerations in calculating sample size; Bayesian statistics; References; Chapter 5: Bias and random error; Introduction; Study design; Bias; Random error; Sample size; Inclusion criteria; Study conduct; Bias; Allocation concealment; Blinded outcome evaluation |
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The scope of investigations for neurological treatments is growingConclusions; Acknowledgement; References; Chapter 2: The sequence of clinical development; Introduction; Early stage clinical development; Middle stage clinical development; Late stage clinical development; Important sources of information; Conclusions; References; Chapter 3: Unique challenges in the development of therapies for neurological disorders; Introduction; Why are CNS diseases difficult to treat?; Targets; Animal models of CNS biology and 'human disease'; Blood brain barrier and its impact on CNS drug development |
Summary |
Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences |
Notes |
Other considerations in analyzing clinical trial data: Missing data and imputation |
Bibliography |
Includes bibliographical references and index |
Notes |
Print version record |
Subject |
Clinical trials.
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Neurology -- Research -- Methodology.
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Clinical Trials as Topic -- methods.
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Nervous System Diseases -- therapy.
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Drug Design.
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Form |
Electronic book
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Author |
Cummings, Jeff.
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McDermott, Michael.
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Poole, R. Michael
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ISBN |
0521762596 |
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1139032445 (electronic book) |
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1139376586 |
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1139379445 (electronic bk.) |
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9780521762595 |
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9781139032445 (electronic book) |
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9781139376587 |
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9781139379441 (electronic bk.) |
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