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Sample size determination in clinical trials with multiple endpoints [electronic resource] / Takashi Sozu, Tomoyuki Sugimoto, Toshimitsu Hamasaki, Scott R. Evans.

Sozu, Takashi, author.; Sugimoto, Tomoyuki, author.; Hamasaki, Toshimitsu, author.; Evans, Scott R., author.
2015
R853.C55
Available Online
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Title
Sample size determination in clinical trials with multiple endpoints [electronic resource] / Takashi Sozu, Tomoyuki Sugimoto, Toshimitsu Hamasaki, Scott R. Evans.
ISBN
9783319220055 electronic book
3319220055 electronic book
9783319220048
DOI
https://doi.org/10.1007/978-3-319-22005-5
Published
Cham : Springer, [2015]
Copyright
©2015
Language
English
Description
1 online resource (vi, 95 pages) : illustrations.
Item Number
10.1007/978-3-319-22005-5 doi
Call Number
R853.C55
Dewey Decimal Classification
615.5072/4
Summary
This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clinical trials where the alternative hypothesis is that there are effects on ALL endpoints are discussed in detail. The book also brieƠ̐ℓy examines trials designed with an alternative hypothesis of an effect on AT LEAST ONE endpoint with a prespeciƠ̐ℓed non-ordering of endpoints. ℗ℓ.
Bibliography, etc. Note
Includes bibliographical references.
Access Note
Access limited to authorized users.
Source of Description
Online resource; title from PDF title page (viewed August 27, 2015)
Added Author
Sozu, Takashi, author.
Sugimoto, Tomoyuki, author.
Hamasaki, Toshimitsu, author.
Evans, Scott R., author.
Series
SpringerBriefs in statistics.
Available in Other Form
Print version: 9783319220048
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1.Introduction
2.Continuous Co-primary Endpoints
3.Binary Co-primary Endpoints
4.Convenient Sample Size Formula
5.Continuous Primary Endpoints
6. Further Developments
A.Sample Size Calculation Using other Contrasts for Binary Endpoints
B.Empirical Power for Sample Size Calculation for Binary Co-primary Endpoints
C.Numerical Tables for Ck in the Convenient Sample Size Formula for the Three Co-primary Continuous Endpoints Cace
D.Software Programs for Sample Size Calculation for Continuous Co-primary Endpoints
References.

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