عنوان
پدید آورنده
موضوع
رده
R853.C55 T544 2015
R853
.
C55
T544
2015
کتابخانه
محل استقرار
INTERNATIONAL STANDARD BOOK NUMBER
(Number (ISBN
1466561491
(Number (ISBN
9781466561496
NATIONAL BIBLIOGRAPHY NUMBER
Number
b544322
TITLE AND STATEMENT OF RESPONSIBILITY
Title Proper
Noninferiority testing in clinical trials :
General Material Designation
[Book]
Other Title Information
issues and challenges
First Statement of Responsibility
Tie-Hua Ng.
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Boca Raton
Name of Publisher, Distributor, etc.
Taylor & Francis/CRC Press
Date of Publication, Distribution, etc.
[2015]
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
xvii, 190 pages : illustratons ; 25 cm.
SERIES
Series Title
Chapman & Hall/CRC biostatistics series.
CONTENTS NOTE
Text of Note
1. Introduction --;2. Choice of noninferiority margin for the mean difference --;3. Choice of noninferiority margin for the mean ratio and hazard ratio --;4. Noninferiority Hypotheses with Binary Endpoints --;5. Two statistical approaches for testing the noninferiority hypothesis --;6. Switching between superiority and noninferiority --;7. Multiple historical studies and meta-analysis --;8. Three treatment groups --;9. Regulatory guidances --;10. Intention-to-treat versus per-protocol --;11. Thrombolytic example --;12. Issues and challenges.
SUMMARY OR ABSTRACT
Text of Note
This book focuses on the rationale of choosing the noninferiority (NI) margin as a small fraction of the therapeutic effect of the active control in a clinical trial. It discusses issues of estimating the effect size based on historical placebo control trials of the active control. The book also covers basic concepts related to NI trials, such as essay sensitivity, constancy assumption, discounting, and preservation. Other topics described include patient populations, three-arm trials, and testing equivalence of three or more groups--Provided by publisher.
TOPICAL NAME USED AS SUBJECT
Clinical trials -- Statistical methods.
Data Interpretation, Statistical.
Drugs -- Therapeutic equivalency.
LIBRARY OF CONGRESS CLASSIFICATION
Class number
R853
.
C55
Book number
T544
2015
PERSONAL NAME - PRIMARY RESPONSIBILITY
Tie-Hua Ng.
PERSONAL NAME - ALTERNATIVE RESPONSIBILITY
Tie-Hua Ng
ELECTRONIC LOCATION AND ACCESS
Electronic name
مطالعه متن کتاب [Book]
Y
