Statistical Methods for Clinical Trials

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ISBN: 9780824704674 | 0824704673
Cover: Hardcover
Copyright: 11/8/2000

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Discusses statistical concepts including statistical power, multiplicity, testing for therapeutic equivalence, and missing values, which are commonly encountered in clinical research and development. For clinical researchers and scientists, and biostatisticians. Expanded-outline format.

Series Introduction

Preface

vii

The Logical Basis of Clinical Studies and Statistical Methods

(16)

The logical basis of clinical studies

(2)

The principle of statistical methods

(2)

Statistical methods for clinical studies

(12)

Data visualization and graphical data analysis

(2)

Comparison of summary measures

(2)

The analysis of variance

(1)

The analysis of dispersion

(2)

Permutation test

(5)

Graphical Data Analysis

(20)

Cross display of data distribution

(2)

Categorical data and continuous data

(1)

Direct display of frequencies

(5)

Bar chart for categorical data

(1)

Picket fence plot for continuous data

(3)

Histogram for continuous data

(1)

Cumulative frequency plot for continuous data

(3)

Box plot for showing main body and outliers

(2)

Delta plot and tree plot for within-patient contrasts

(4)

Delta plot for change from baseline

(2)

Tree plot for efficacy analysis

(2)

Scatter plot for profile analysis

(4)

Data Analysis with Summary Measures

(12)

Cross tabulation and display of summary measures

(3)

Number of patients for reliability and robustness

(2)

Mean and number of observations for categorical data

(1)

Frequently used summary measures

(6)

Mean and median

(2)

Standard deviation and average deviation

(1)

Standard error

(3)

The Analysis of Variance

(26)

The method

(3)

Basic operations in the analysis of variance

(6)

Controlled versus uncontrolled factors

(1)

Grouping and curve fitting

(2)

Linear models as a technical language

(1)

Effects and their measurement

(6)

Type I measure

(1)

Type II measure

(2)

Type III measure

(2)

Pros and cons and making choices

(1)

Presentation of analysis results

(6)

Graphical presentation

(1)

Marginal means or least squares means

(3)

The analysis of variance table

(1)

Limitations

(1)

Pairwise comparisons of multiple means

(2)

The analysis of variance for categorical data

(3)

Frequently Debated Issues in the Analysis of Clinical Trial Data

(18)

An overview

(1)

No center-treatment interaction

(2)

The effects of center-treatment interaction

(2)

The analysis of variance with covariates

(5)

Baseline measures

(1)

Statistical adjustment for the effects of covariates

(3)

Mean response profiles in a time course

(5)

Far-from-average individual response profiles

(2)

Nonparametric Analysis, Analysis on a Complex Scale, Analysis of Longitudinal Data, and Mixed Linear Models

(16)

An overview

(1)

Nonparametric analysis

(1)

The analysis of variance on a complex scale

(5)

Recent proposals for the analysis of longitudinal data

100

(5)

Analysis of longitudinal data with mixed linear models

105

(4)

Survival Analysis

109

(14)

Survival data and summary measures

109

(2)

Cross tabulation of death and projected survival rates

111

(2)

Kaplan-Meier plot of projected survival rates

113

(3)

The analysis of variance on survival data

116

(3)

Analysis of variance with proportional hazard models

119

(4)

The Design of Clinical Study Programs

123

(34)

An overview

123

(1)

Parallel and crossover setups

124

(6)

Parallel setups

124

(3)

Crossover setups

127

(3)

Randomization

130

(1)

Stratification

131

(2)

Blinding

133

(2)

Control

135

(6)

Longitudinal control

135

(2)

Parallel control

137

(1)

Placebo control versus active control

138

(2)

Pivotal control in clinical study program

140

(1)

Studies for dose-efficacy-safety relationship

141

(6)

Confounding factors in evaluation of dosing

142

(2)

Dose escalating studies

144

(2)

Reflection on the traditional phases II and III paradigm

146

(1)

Studies for treatment substitution

147

(2)

Target range of disease control and study sensitivity

147

(1)

Patient heterogeneity and disease fluctuation

148

(1)

Determination of sample size

149

(8)

Sampling unit

150

(1)

Criteria for projecting sample size

150

(5)

Measurement of efficiency

155

(2)

Integration of Clinical Studies

157

(34)

An overview

157

(2)

The principle of integration

159

(6)

Consistency and heterogeneity

159

(2)

Parameters to consider in planning integration studies

161

(2)

Source of information

163

(2)

The quality of clinical studies

165

(6)

The integrity of study design

165

(2)

The sufficiency of observations

167

(1)

Documentation in clinical study reports

168

(3)

Graphical analysis of integrated studies

171

(7)

Stratification by quality

171

(2)

Graphical arrays

173

(5)

The analysis of variance on pooled data

178

(6)

Common ground and appropriate stratification

178

(5)

An analysis of variance technique for compiling studies

183

(1)

Some other techniques in meta-analysis

184

(7)

The analysis of variance on summary measures

184

(3)

Effect size versus group-specific measures

187

(1)

Variations among studies and the random effects

188

(3)

The Fiction Behind the Current Statistics and Its Consequences

191

(16)

An overview

191

(1)

The fantasy of truth and the concept of errors

192

(1)

Assumption of distribution

193

(3)

P-value

196

(1)

Confidence interval

197

(1)

Devastating impact on clinical research

198

(3)

Multiplicity

198

(2)

Statistical power and sample size

200

(1)

Statistical inference and testing for equivalence

201

(3)

The maximum likelihood technique

204

(1)

Clinical research and statistical methods

205

(2)

Good Clinical Practice Guidelines

207

(14)

A brief history

207

(1)

An overview

208

(1)

Benefits of compliance with GCP guidelines

209

(1)

Investigators

210

(4)

Responsibilities

210

(2)

Necessary resources for an investigator site

212

(2)

Institutional review boards

214

(1)

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Statistical Methods for Clinical Trials

Summary

Table of Contents

Supplemental Materials