Sample Size Calculations in Clinical Research, Second Edition N-Solution bundle version / Edition 2

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More About This Textbook


This book explains how the formulas and procedures for sample size calculations can be used in a variety of clinical research and development stages. It presents real-world examples from several therapeutic areas and explores emerging topics in pharmaceutical research and development. This edition now provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches. It also includes a basic version of PharmaSoftware Solutions, Inc.’s N Solution 2007. Along with sensitivity analyses for each procedure, the software contains all procedures for testing equality, superiority/noninferiority, and equivalence for comparing means, proportions, and time-to-event data.

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Product Details

  • ISBN-13: 9781439813591
  • Publisher: Taylor & Francis
  • Publication date: 3/23/2009
  • Series: Chapman & Hall/CRC Biostatistics Series
  • Edition number: 2
  • Pages: 480
  • Product dimensions: 6.40 (w) x 9.40 (h) x 1.30 (d)

Table of Contents



Regulatory Requirement

Basic Considerations

Procedures for Sample Size Calculation

Aims and Structure of the Book

Considerations Prior to Sample Size Calculation

Confounding and Interaction

One-Sided Test versus Two-Sided Test

Crossover Design versus Parallel Design

Subgroup/Interim Analyses

Data Transformation

Practical Issues

Comparing Means

One-Sample Design

Two-Sample Parallel Design

Two-Sample Crossover Design

Multiple-Sample One-Way ANOVA

Multiple-Sample Williams Design

Practical Issues

Large Sample Tests for Proportions

One-Sample Design

Two-Sample Parallel Design

Two-Sample Crossover Design

One-Way Analysis of Variance

Williams Design

Relative Risk—Parallel Design

Relative Risk—Crossover Design

Practical Issues

Exact Tests for Proportions

Binomial Test

Fisher’s Exact Test

Optimal Multiple-Stage Designs for Single Arm Trials

Flexible Designs for Multiple-Arm Trials


Tests for Goodness-of-Fit and Contingency Tables

Tests for Goodness-of-Fit

Test for Independence—Single Stratum

Test for Independence—Multiple Strata

Test for Categorical Shift

Carry-Over Effect Test

Practical Issues

Comparing Time-to-Event Data

Basic Concepts

Exponential Model

Cox’s Proportional Hazards Model

Weighted Log-Rank Test

Practical Issues

Group Sequential Methods

Pocock’s Test

O’Brien and Fleming’s Test

Wang and Tsiatis’ Test

Inner Wedge Test

Binary Variables

Time-to-Event Data

Alpha Spending Function

Sample Size Re-Estimation

Conditional Power

Practical Issues

Comparing Variabilities

Comparing Intra-Subject Variabilities

Comparing Intra-Subject CVs

Comparing Inter-Subject Variabilities

Comparing Total Variabilities

Practical Issues

Bioequivalence Testing

Bioequivalence Criteria

Average Bioequivalence

Population Bioequivalence

Individual Bioequivalence

In Vitro Bioequivalence

Dose Response Studies

Continuous Response

Binary Response

Time-to-Event Endpoint

Williams’ Test for Minimum Effective Dose (MED)

Cochran–Armitage’s Test for Trend

Dose Escalation Trials

Concluding Remarks

Microarray Studies

Literature Review

False Discovery Rate (FRD) Control

Family-Wise Error Rate (FWER) Control

Concluding Remarks

Bayesian Sample Size Calculation

Posterior Credible Interval Approach

Posterior Error Approach

The Bootstrap-Median Approach

Concluding Remarks


Violation of Assumptions

One-Sample Location Problem

Two-Sample Location Problem

Test for Independence

Practical Issues

Sample Size Calculation in Other Areas

QT/QTc Studies with Time-Dependent Replicates

Propensity Analysis in Nonrandomized Studies

ANOVA with Repeated Measures

Quality of Life

Bridging Studies

Vaccine Clinical Trials


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