Analysis of Safety Data of Drug Trials An Update /

• Κύριοι συγγραφείς: Cleophas, Ton J. (Συγγραφέας, http://id.loc.gov/vocabulary/relators/aut), Zwinderman, Aeilko H. (http://id.loc.gov/vocabulary/relators/aut)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2019.
• Έκδοση: 1st ed. 2019.
• Θέματα: Medicine.; Statistics .; Biomedicine, general.; Statistics and Computing/Statistics Programs.

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...

Πίνακας περιεχομένων:

• 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. .