Analysis of Safety Data of Drug Trials An Update
The authors, as professors in statistics at various universities in Europe, are worrried about the poor quality of safety data analysis of clinical trials, despite its importance in drug development and pharmacovigilance. Clinical trials, not adequately addressing safety, are unethical. An effective...
| Main Authors: | , |
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| Format: | eBook |
| Language: | English |
| Published: |
Cham
Springer International Publishing
2019, 2019
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| Edition: | 1st ed. 2019 |
| Subjects: | |
| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- Preface
- General Introduction
- Significant and Insignificant Adverse Effect
- Incidence Ratios and Reporting Ratios of Adverse Effects
- Safety Analysis and the Alternative Hypothesis
- Forest Plots of Adverse Effects
- Graphics of Adverse Effects
- Repeated Measures Methods for Testing Adverse Effects
- Benefit Risk Ratios
- Equivalence, Non-inferiority and Superiority Testing of Adverse Effects
- Part II The Analysis of Dependent Adverse Effects
- Independent and Dependent Adverse Effects. Categorical Predictors Assessed as Dependent Adverse Effects. Adverse Effect of the Dependent Type in Crossover Trial
- Confoundings and Interactions Assessed as Dependent Adverse Effects
- Subgroup Characteristics Assessed as Dependent Adverse Effects
- Random Effects Assessed as Dependent Adverse Effects
- Outliers Assessed as Dependent Adverse Effects
- Index.