| Description |
1 online resource (388 pages) |
| Series |
Cambridge medicine |
|
Cambridge medicine (Series)
|
| 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 |
|
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 |
|
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 |
|
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 |
|
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.
|
|
Neurology -- Research -- Methodology.
|
|
Clinical Trials as Topic -- methods.
|
|
Nervous System Diseases -- therapy.
|
|
Drug Design.
|
| Form |
Electronic book
|
| Author |
Cummings, Jeff.
|
|
McDermott, Michael.
|
|
Poole, R. Michael
|
| ISBN |
0521762596 |
|
1139032445 (electronic book) |
|
1139376586 |
|
1139379445 (electronic bk.) |
|
9780521762595 |
|
9781139032445 (electronic book) |
|
9781139376587 |
|
9781139379441 (electronic bk.) |
|
