求书:Group sequential methods with applications to clinical trials

                               
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, B; @4 n' L5 g" }/ |  B" LJennison C, Turnbull B. Group sequential methods with applications to clinical trials. Boca Raton: Chapman and Hall,2000.
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9 A6 a- L8 w) `4 g4 I  g, m+ tProvides a clear, practical description of group sequential tests
Explains how to choose the most appropriate test for a given application
4 l: @" m% E3 {* i: QDescribes group sequential stopping rules that reduce average study length and control Type I and II error probabilities
) \; n. z6 s2 w: o7 ]* h( FOffers a presentation that allows easy implementation to a wide variety of data types
& P0 ~# F* `* ]1 Q+ X  YIncludes a survey of current research


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( |* I1 `3 v. }; a& QINTRODUCTION
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• About This Book
• Why Sequential Methods
• A Short History of Sequential and Group Sequential Methods
• Chapter Organization: A Roadmap
• Bibliography and Notes

TWO-SIDED TESTS: INTRODUCTION

• Two-Sided Tests for Comparing Two Treatments with Normal Response of Known Variance
• A Fixed Sample Test
• Group Sequential Tests
• Pocock's Test
• O'Brien and Fleming's Test
• Properties of Pocock and O'Brien and Fleming Tests
• Other Tests
• Conclusions

! @4 |3 S1 D5 t1 o2 ]2 T5 J# TTWO-SIDED TESTS: GENERAL APPLICATIONS

• A Unified Formulation
• Applying the Tests with Equal Group Sizes
• Applying the Tests with Unequal Increments in Information
• Normal Linear Models
• Other Parametric Models
• Binary Data: Group Sequential Tests for Proportions
• The Group Sequential Log-Rank Test for Survival Data
• Group Sequential t-Tests

ONE-SIDED TESTS
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• Introduction
• The Power Family of One-Sided Group Sequential Tests
• Adapting Power Family Tests to Unequal Increments in Information
• Group Sequential One-Sided t-Tests
• Whitehead's Triangular Test

TWO-SIDED TESTS WITH EARLY STOPPING UNDER THE NULL HYPOTHESIS
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• Introduction
• The Power Family of Two-Sided, Inner Wedge Tests
• Whitehead's Double Triangular Test

  R5 h  h5 \. i  rEQUIVALENCE TESTS
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• Introduction
• One-Sided Tests of Equivalence
• Two-Sided Tests of Equivalence: Application to Comparative Bioavailability Studies
• Individual Bioequivalence: A One-Sided Test for Proportions
• Bibliography and Notes

# m4 s/ G3 c3 R7 ]* zFLEXIBLE MONITORING: THE ERROR SPENDING APPROACH

• Unpredictable Information Sequences
• Two-Sided Tests
• One-Sided Tests
• Data Dependent Timing of Analyses
• Computations for Error Spending Tests

ANALYSIS FOLLOWING A SEQUENTIAL TEST
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• Introduction
• Distribution Theory
• Point Estimation
• P-Values
• Confidence intervals

! R' d# v" ~- ?  x- f, b3 _REPEATED CONFIDENCE INTERVALS

• Introduction
• Example: Difference of Normal Means
• Derived Tests: Use of RCIs to Aid Early
• Stopping Decisions
• Repeated P-Values
• Discussion

STOCHASTIC CURTAILMENT
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• Introduction
• Conditional Power Approach
• Predictive Power Approach
• A Parameter-Free Approach
• A Case Study with Survival Data
• Bibliography and Notes

GENERAL GROUP SEQUENTIAL DISTRIBUTION THEORY

• Introduction
• A Standard Joint Distribution for
• Successive Estimates of a Parameter Vector
• Normal Linear Models
• Normal Linear Models with Unknown Variance: Group Sequential t-Tests
• Example: An Exact One-Sample Group Sequential t-Test
• General Parametric Models: Generalized Linear Models
• Connection with Survival Analysis

BINARY DATA

• A Single Bernoulli Probability
• Two Bernoulli Probabilities
• The Odds Ratio and Multiple 2 x 2 Tables
• Case-Control and Matched Pair Analysis
• Logistic Regression: Adjusting for Covariates
• Bibliography and Notes

SURVIVAL DATA
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• Introduction
• The Log Rank Test
• The Stratified Log-Rank Test
• Group Sequential Methods for Survival Data with Covariates
• Repeated Confidence Intervals for a Hazard Ratio
• Example: A Clinical Trial for Carcinoma of the Oropharynx
• Survival Probabilities and Quantiles
• Bibliography and Notes

INTERNAL PILOT STUDIES: SAMPLE SIZE RE-ESTIMATION
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• The Role of an Internal Pilot Phase
• Sample Size Re-estimation for a Fixed Sample Test
• Sample Size Re-estimation in Group Sequential Tests

; M/ E/ T+ T7 |$ r, j% OMULTIPLE ENDPOINTS
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• Introduction
• The Bonferroni Procedure
• A Group Sequential Hotelling Test
• A Group Sequential Version of O'Brien's Test
• Tests Based on other Global Statistics
• Tests Based on Marginal Criteria
• Bibliography and Notes

MULTI-ARMED TRIALS
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• Introduction
• Global Tests
• Monitoring Pairwise Comparisons
• Bibliography and Notes

ADAPTIVE TREATMENT ASSIGNMENT

• A Multi-Stage Adaptive Design
• A Multi-Stage Adaptive Design with Time Trends
• Validity of Adaptive Multi-Stage Procedures
• Bibliography and Notes

BAYESIAN APPROACHES

• The Bayesian Paradigm
• Stopping Rules
• Choice of Prior Distribution
• Discussion

) @0 F: d. v+ r: g# x& dNUMERICAL COMPUTATIONS FOR GROUP SEQUENTIAL TESTS
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• Introduction
• The Basic Calculation
• Error Probabilities and Sample Size Distributions
• Tests Defined by Error Spending Functions
• Analysis Following a Group Sequential Test
• Further Applications of Numerical Computation
• Computer Software

Editorial Reviews
- x; B9 |& Z7 t2 h, FReview
! ?4 V7 q' n& w! z2 mThe statistical methodology for sequential trials is complicated. This book provides an excellent presentation of it. It succeeds as both a training text and as a reference source. I liked the progression of the book…any statistician involved in designing or analysing sequential trials should have a copy.
--Tim Auton, Protherics, Macclesfield
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The statistical methodology for sequential trials is complicated. This book provides an excellent presentation of it. It succeeds as both a training text and as a reference source. I liked the progression of the book…any statistician involved in designing or analysing sequential trials should have a copy.
. A$ r0 }+ c  f; X--Tim Auton, Protherics, Macclesfield
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This book represents a comprehensive presentation of group sequential methods. Written by active researchers in this area, it provides an ideal source for those wishing an introduction to the area and for those who desire a clear outline of specific topics or methods. It should quickly become a standard reference both for those wishing to apply the methods and for researchers in the area…The extent of coverage of various topics broadly reflects current usage…the discussion of each topic appears to be well balanced…All in all, this is a very welcome book.
* D2 e: b" S2 n0 P& C- Short Book Reviews of the ISI

$ j* x. k6 O5 g! u  _This book represents a comprehensive presentation of group sequential methods. Written by active researchers in this area, it provides an ideal source for those wishing an introduction to the area and for those who desire a clear outline of specific topics or methods. It should quickly become a standard reference both for those wishing to apply the methods and for researchers in the area…The extent of coverage of various topics broadly reflects current usage…the discussion of each topic appears to be well balanced…All in all, this is a very welcome book.
& E0 x% p& t$ t- M& P- Short Book Reviews of the ISI
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Product Description
$ B# i3 ^/ l2 bGroup sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion.Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models.Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.

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8 L3 X# A% ?( i6 E0 c3 l) z& U* KProduct Details
. |5 _9 [- @9 `5 J! pHardcover: 416 pages
Publisher: Chapman & Hall/CRC; 1 edition (September 15, 1999)
, g+ n- t, X* r9 F- WLanguage: English
ISBN-10: 0849303168
ISBN-13: 978-0849303166
Product Dimensions: 9.2 x 6.2 x 1.1 inches
Shipping Weight: 1.5 pounds (View shipping rates and policies)

+ W$ G4 P* h$ S! S& v% V; q0 dMost Helpful Customer Reviews
; [' w( x: T" F+ k5 \* F7 ~6 JAdvances in the theory of repeated significance testing in the 1980s and 1990s has made sequential methods practical by identifying stopping rules for data collected sequentially but in groups. This material is now used to plan interim analyses and both safety and efficacy group sequential trials for clinical trials. This text provides for the first time thorough coverage of these advances with suitable references to the literature.
: F6 c6 k9 ~( a  ?, ~0 c5 g, L3 ^5 MIt should be on the bookshelf of any biostatistician who conducts clinical trials for pharmaceutical or medical device companies.
9 c/ M( ~* N- U% U& f
! B- K( l4 Y, R8 x5 jAdvances in the theory of repeated significance testing in the 1980s and 1990s has made sequential methods practical by identifying stopping rules for data collected sequentially but in groups. This material is now used to plan interim analyses and both safety and efficacy group sequential trials for clinical trials. This text provides for the first time thorough coverage of these advances with suitable references to the literature.
It should be on the bookshelf of any biostatistician who conducts clinical trials for pharmaceutical or medical device companies.

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