(EBOOK PDF) Noninferiority Testing in Clinical Trials Issues and Challenges 1st Edition by Tie Hua ISBN 1466561505 9781466561502 full chapters

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Product details:

ISBN 10: 1466561505

ISBN 13: 9781466561502

Author:  Tie-Hua Ng 

Noninferiority Testing in Clinical Trials Issues and Challenges 1st Edition: 

Take Your NI Trial to the Next Level

Reflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development.

With over 20 years of experience in this area, the author introduces the basic elements of the NI trials one at a time in a logical order. He discusses issues with estimating the effect size based on historical placebo control trials of the active control. The book covers fundamental concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. It also describes patient populations, three-arm trials, and the equivalence of three or more groups.

 

Noninferiority Testing in Clinical Trials Issues and Challenges 1st Edition Table of contents:

Chapter 1: Introduction

Chapter 2: Choice of Noninferiority Margin for the Mean Difference

Chapter 3: Choice of Noninferiority Margin for the Mean Ratio and Hazard Ratio

Chapter 4: Noninferiority Hypotheses with Binary Endpoints

Chapter 5: Two Statistical Approaches for Testing the Noninferiority Hypothesis

Chapter 6: Switching between Superiority and Noninferiority

Chapter 7: Multiple Historical Studies and Meta-Analysis

Chapter 8: Three Treatment Groups

Chapter 9: Regulatory Guidances

Chapter 10: Intention-to-Treat versus Per-Protocol

Chapter 11: Thrombolytic Example

Chapter 12: Issues and Challenges

 

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