Sample size calculations in clinical research

by Chow, Shein-Chung Lokhnygina, Yuliya Shao, Jun, (Statistician) Wang, Hansheng

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"Like the well-regarded and bestselling second edition, Sample Size Calculations in Clinical Research, Third Edition, presents statistical procedures for performing sample size calculations during various phases of clinical research and development. This new edition will be updated throughout and will contain four entirely new chapters written especially for this edition."--Provided by publisher.

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Title Statements

Full title :Sample size calculations in clinical research / Shein-Chung Chow, Jun Shao, Hansheng Wang, and Yuliya Lokhnygina.

Summary

Edition Statements

Publication Date:2017.
Edition:Third edition

Publication Statements

Publisher(s):CRC Press
Place of Publication:Boca Raton, FL
Language:eng
Publication Date:2017.

Notes

"A Chapman & Hall book."

The Physical Object

Description:1 online resource : : text file, PDF

Edition Identifiers

ISBN:9781315183084, 1315183080, 1351727125, 9781351727129
oclc:ocn993983487
LC Classification:R853.S7
Dewey Decimal:610.72/7

Cover; Half Title; Published Titles; Title Page; Copyright Page; Contents; Preface; 1. Introduction; 1.1 Regulatory Requirement; 1.1.1 Adequate and Well-Controlled Clinical Trials; 1.1.2 Substantial Evidence; 1.1.3 Why At Least Two Studies?; 1.1.4 Substantial Evidence with a Single Trial; 1.1.5 Sample Size; 1.2 Basic Considerations; 1.2.1 Study Objectives; 1.2.2 Study Design; 1.2.3 Hypotheses; 1.2.3.1 Test for Equality; 1.2.3.2 Test for Noninferiority; 1.2.3.3 Test for Superiority; 1.2.3.4 Test for Equivalence; 1.2.3.5 Relationship among Noninferiority, Superiority, and Equivalence.

1.2.4 Primary Study Endpoint1.2.5 Clinically Meaningful Difference; 1.3 Procedures for Sample Size Calculation; 1.3.1 Type I and Type II Errors; 1.3.2 Precision Analysis; 1.3.3 Power Analysis; 1.3.4 Probability Assessment; 1.3.5 Reproducibility Probability; 1.3.6 Sample Size Reestimation without Unblinding; 1.4 Aims and Structure of this Book; 1.4.1 Aim of this Book; 1.4.2 Structure of this Book; 2. Considerations Prior to Sample Size Calculation; 2.1 Confounding and Interaction; 2.1.1 Confounding; 2.1.2 Interaction; 2.1.3 Remark; 2.2 One-Sided Test versus Two-Sided Test; 2.2.1 Remark.

2.3 Crossover …

Subjects

Biometry -- methods Clinical medicine -- Research Drug development -- Statistical methods Échantillonnage (Statistique) HEALTH & FITNESS -- Holism HEALTH & FITNESS -- Reference Médecine clinique -- Recherche MEDICAL -- Alternative Medicine MEDICAL -- Atlases MEDICAL -- Biostatistics MEDICAL -- Essays MEDICAL -- Family & General Practice MEDICAL -- Holistic Medicine MEDICAL -- Osteopathy MEDICAL -- Pharmacology Médicaments -- Développement Sample Size Sampling (statistics)