Group Sequential Methods with Applications to Clinical Trials

Forside
CRC Press, 15. sep. 1999 - 416 sider
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Group 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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Innhold

Introduction
1
12 Why Sequential Methods
3
13 A Short History of Sequential and Group Sequential Methods
5
14 Some Examples
11
A Roadmap
15
16 Bibliography and Notes
18
TwoSided Tests Introduction
21
22 A Fixed Sample Test
22
General Group Sequential Distribution Theory
221
113 Normal Linear Models
222
Group Sequential rTests
224
An Exact OneSample Group Sequential tTest
226
Generalized Linear Models
228
117 Bibliography and Notes
232
Binary Data
235
122 Two Bernoulli Probabilities
244

23 Group Sequential Tests
23
24 Pococks Test
24
25 OBrien Flemings Test
29
26 Properties of Pocock and OBrien Fleming Tests
31
27 Other Tests
39
28 Conclusions
47
TwoSided Tests General Applications
49
32 Applying the Tests with Equal Group Sizes
53
33 Applying the Tests with Unequal Increments in Information
57
34 Normal Linear Models
62
35 Other Parametric Models
70
Group Sequential Tests for Proportions
74
37 The Group Sequential LogRank Test for Survival Data
77
38 Group Sequential rTests
79
OneSided Tests
87
42 The Power Family of OneSided Group Sequential Tests
89
43 Adapting Power Family Tests to Unequal Increments in Information
96
44 Group Sequential OneSided tTests
99
45 Whiteheads Triangular Test
105
TwoSided Tests with Early Stopping Under the Null Hypothesis
111
52 The Power Family of TwoSided Inner Wedge Tests
112
53 Whiteheads Double Triangular Test
123
Equivalence Tests
129
62 OneSided Tests of Equivalence
130
A OneSided Test for Proportions
141
65 Bibliography and Notes
143
Flexible Monitoring The Error Spending Approach
145
72 TwoSided Tests
146
73 OneSided Tests
161
74 Data Dependent Timing of Analyses
166
75 Computations for Error Spending Tests
169
Analysis Following a Sequential Test
171
83 Point Estimation
175
84 Pvalues
179
85 Confidence Intervals
181
Repeated Confidence Intervals
189
Difference of Normal Means
193
Use of RCIs to Aid Early Stopping Decisions
194
94 Repeated Pvalues
202
Stochastic Curtailment
205
103 The Predictive Power Approach
210
104 A ParameterFree Approach
213
105 A Case Study with Survival Data
215
106 Bibliography and Notes
219
123 The Odds Ratio and Multiple 2x2 Tables
251
124 CaseControl and Matched Pair Analyses
254
Adjusting for Covariates
256
126 Connection with Survival Analysis
257
Survival Data
259
132 The LogRank Test
260
133 The Stratified LogRank Test
261
134 Group Sequential Methods for Survival Data with Covariates
262
135 Repeated Confidence Intervals for a Hazard Ratio
265
A Clinical Trial for Carcinoma of the Oropharynx
267
137 Survival Probabilities and Quantiles
274
138 Bibliography and Notes
276
Internal Pilot Studies Sample Size Reestimation
279
142 Sample Size Reestimation for a Fixed Sample Test
281
143 Sample Size Reestimation in Group Sequential Tests
293
Multiple Endpoints
299
152 The Bonferroni Procedure
300
153 A Group Sequential HoteUing Test
302
154 A Group Sequential Version of OBriens Test
306
155 Tests Based on Other Global Statistics
310
156 Tests Based on Marginal Criteria
311
157 Bibliography and Notes
314
MultiArmed Trials
317
163 Monitoring Pairwise Comparisons
321
164 Bibliography and Notes
324
Adaptive Treatment Assignment
327
172 A MultiStage Adaptive Design with Time Trends
331
173 Validity of Adaptive Multistage Procedures
333
174 Bibliography and Notes
335
Bayesian Approaches
337
182 Stopping Rules
338
183 Choice of Prior Distribution
341
184 Discussion
343
Numerical Computations for Group Sequential Tests
345
192 The Basic Calculation
346
193 Error Probabilities and Sample Size Distributions
351
194 Tests Defined by Error Spending Functions
353
195 Analysis Following a Group Sequential Test
355
196 Further Applications of Numerical Computation
357
197 Computer Software
360
References
363
Index
387
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