Noninferiority testing in clinical trials : issues and challenges /: issues and challenges. (2014)

• Record Type: Book
• Further Information: Note: Tie-Hua Ng.
• Authors: Ng, Tie-Hua
• Contents: Introduction ; Equivalence and Noninferiority Testing; One-Sided and Two-Sided Hypotheses; Equivalence Margin δ; Choice of δ; Ethical Issues and Declaration of Helsinki; Conventional Approach versus Role-Reversal Approach; Notations and Noninferiority Hypotheses Choice of Noninferiority Margin for the Mean Difference ; Introduction; Proposed δ; Motivations; Choice of ε and Interpretation; How Do You Know the Effect Size?; Assay Sensitivity; Constancy Assumption versus Assay Sensitivity; Discussion Choice of Noninferiority Margin for the Mean Ratio and Hazard Ratio; Introduction; Why Mean Ratio?; Mean Ratio for Continuous Endpoints; Hazard Ratio for Survival Endpoints; Discussion Noninferiority Hypotheses with Binary Endpoints ; Introduction; Noninferiority Hypothesis Based on the Difference or Ratio of Two Proportions; NI Hypothesis Based on the Odds Ratio; Discussion Two Statistical Approaches for Testing the Noninferiority Hypothesis ; Introduction; One-Sided versus Two-Sided; Fixed-Margin Method; Synthesis Method; Fixed-Margin Method versus Synthesis Method; Efficacy; Preservation versus Discounting; Control of Type I Error Rates Switching between Superiority and Noninferiority ; Introduction; Background; Statistical Issues with Simultaneous Testing; Decision-Theoretic Views; Conditional Type I Error Rate in Superiority Testing; Discussion and Concluding Remarks Multiple Historical Studies and Meta-Analysis ; Introduction; Meta-Analysis and Systematic Review; Fixed-Effect Model; Random-Effects Model; Constancy Assumption in the Context of Meta-Analysis; Discounting-and-then-Pooling Approach; Discussion Three Treatment Groups ; Introduction; Gold-Standard Design; Two Test Treatments versus an Active Control; Equivalence of Three Test Groups Regulatory Guidances ; Introduction; Guidelines in the Anti-Infective Area with a Binary Endpoint; EMEA/CPMP Document; FDA Draft Guidance Intention-to-Treat versus Per-Protocol ; Introduction; Background; Analyses of Randomized Control Trials; Intention-to-Treat Analysis versus Per-Protocol Analysis in Superiority Trials; Intention-to-Treat Analysis versus Per-Protocol Analysis in Noninferiority Trials; Implementation of an Intention-to-Treat Analysis in Randomized Control Trials Thrombolytic Example ; Introduction; Background; CBER Criteria in the Assessment of New Thrombotics in June 1999; Discussion Issues and Challenges ; Introduction; Fundamental Issues; Advances in Noninferiority Trials; Current Controversial Issues; Issues and Challenges Index References appear at the end of each chapter.
• Edition: 1st
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2014
• Extent: 1 online resource, illustrations (black and white)
• Subjects: 615.50724; Clinical trials; Statistics
• Languages: English
• ISBNs: 9781466561502
• Related ISBNs: 9781466561496
• Notes: Note: Includes bibliographical references and index.; Note: Description based on CIP data; item not viewed.
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