| Description |
1 online resource (xxi, 559 pages) : illustrations |
| Contents |
Hypotheses, data, stratification -- The analysis of efficacy data -- The analysis of safety data -- Log likelihood ratio tests for safety data analysis -- Equivalence testing -- Statistical power and sample size -- Interim analyses -- Controlling the risk of false positive clinical trials -- Multiple statistical inferences -- The interpretation of the p-values -- Research data closer to expectation than compatible with random sampling -- Statistical tables for testing data closer to expectation than compatible with random sampling -- Principles of linear regression -- Subgroup analysis using multiple linear regression: confounding, interaction, synergism -- Curvilinear regression -- Logistic and Cox regression, Markow models, Laplace transformations -- Regression modeling for improved precision -- Regression modeling for improved precision -- Post-hoc analyses in clinical trials, a case for logistic regression analysis -- Confounding -- Interaction -- Meta-analysis, basic approach -- Meta-analysis, review and update of methodologies -- Crossover studies with continuous variables -- Crossover studies with binary responses -- Cross-over trials should not be used to test treatments with different chemical class -- Quality-of-life assessments in clinical trials -- Statistical analysis of genetic data -- Relationship among statistical distributions -- Testing clinical trials for randomness -- Clinical trials do not use random samples anymore -- Clinical data where variability is more important than averages -- Testing reproducibility -- Validating qualitative diagnostic tests -- Uncertainty of qualitative diagnostic tests -- Meta-analysis of diagnostic accuracy studies -- Validating quantitative diagnostic tests -- Summary of validation procedures for diagnostic tests -- Validating surrogate endpoints of clinical trials -- Methods for repeated measures analysis -- Advanced analysis of variance, random effects and mixed effects models -- Monte Carlo methods -- Physicians' daily life and the scientific method -- Clinical trials: superiority-testing -- Trend-testing -- Odds ratios and multiple regression models, why and how to use them -- Statistics is no "bloodless" algebra -- Bias due to conflicts of interests, some guidelines |
| Summary |
Explains classical statistical analysis of clinical trials. This book addresses relatively novel issues, including equivalence testing, interim analysis, sequential analysis, meta-analysis, and provides a framework of the best statistical methods available for such purpose. It is suitable for investigators in the field of clinical trials |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Drugs -- Testing -- Statistical methods
|
|
Clinical trials -- Statistical methods
|
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Clinical Trials as Topic -- methods
|
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Data Interpretation, Statistical
|
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Clinical trials -- Statistical methods
|
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Drugs -- Testing -- Statistical methods
|
| Form |
Electronic book
|
| Author |
Cleophas, Ton J. M
|
| ISBN |
9781402095238 |
|
1402095236 |
|
9786611954789 |
|
6611954783 |
|
