Group Sequential Methods with Applications to Clinical Trials

Forside
CRC Press, 15. sep. 1999 - 416 sider
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
xix
12 Why Sequential Methods
1
13 A Short History of Sequential and Group Sequential Methods
3
14 Some Examples
9
A Roadmap
13
16 Bibliography and Notes
16
TwoSided Tests Introduction
19
23 Group Sequential Tests
21
General Group Sequential Distribution Theory
219
113 Normal Linear Models
220
Group Sequential rTests
222
An Exact OneSample Group Sequential tTest
224
Generalized Linear Models
226
117 Bibliography and Notes
230
Binary Data
233
122 Two Bernoulli Probabilities
242

24 Pococks Test
22
25 OBrien Flemings Test
27
26 Properties of Pocock and OBrien Fleming Tests
29
27 Other Tests
37
28 Conclusions
45
TwoSided Tests General Applications
47
32 Applying the Tests with Equal Group Sizes
51
33 Applying the Tests with Unequal Increments in Information
55
34 Normal Linear Models
60
35 Other Parametric Models
68
Group Sequential Tests for Proportions
72
37 The Group Sequential LogRank Test for Survival Data
75
38 Group Sequential rTests
77
OneSided Tests
85
42 The Power Family of OneSided Group Sequential Tests
87
43 Adapting Power Family Tests to Unequal Increments in Information
94
44 Group Sequential OneSided tTests
97
45 Whiteheads Triangular Test
103
TwoSided Tests with Early Stopping Under the Null Hypothesis
109
52 The Power Family of TwoSided Inner Wedge Tests
110
53 Whiteheads Double Triangular Test
121
Equivalence Tests
127
A OneSided Test for Proportions
139
65 Bibliography and Notes
141
Flexible Monitoring The Error Spending Approach
143
72 TwoSided Tests
144
73 OneSided Tests
159
74 Data Dependent Timing of Analyses
164
75 Computations for Error Spending Tests
167
Analysis Following a Sequential Test
169
83 Point Estimation
173
84 Pvalues
177
85 Confidence Intervals
179
Repeated Confidence Intervals
187
Difference of Normal Means
191
Use of RCIs to Aid Early Stopping Decisions
192
94 Repeated Pvalues
200
Stochastic Curtailment
203
103 The Predictive Power Approach
208
104 A ParameterFree Approach
211
105 A Case Study with Survival Data
213
106 Bibliography and Notes
217
123 The Odds Ratio and Multiple 2x2 Tables
249
124 CaseControl and Matched Pair Analyses
252
Adjusting for Covariates
254
126 Connection with Survival Analysis
255
Survival Data
257
133 The Stratified LogRank Test
259
134 Group Sequential Methods for Survival Data with Covariates
260
135 Repeated Confidence Intervals for a Hazard Ratio
263
A Clinical Trial for Carcinoma of the Oropharynx
265
137 Survival Probabilities and Quantiles
272
138 Bibliography and Notes
274
Internal Pilot Studies Sample Size Reestimation
277
142 Sample Size Reestimation for a Fixed Sample Test
279
143 Sample Size Reestimation in Group Sequential Tests
291
Multiple Endpoints
297
153 A Group Sequential HoteUing Test
300
154 A Group Sequential Version of OBriens Test
304
155 Tests Based on Other Global Statistics
308
156 Tests Based on Marginal Criteria
309
157 Bibliography and Notes
312
MultiArmed Trials
315
163 Monitoring Pairwise Comparisons
319
164 Bibliography and Notes
322
Adaptive Treatment Assignment
325
172 A MultiStage Adaptive Design with Time Trends
329
173 Validity of Adaptive Multistage Procedures
331
174 Bibliography and Notes
333
Bayesian Approaches
335
182 Stopping Rules
336
183 Choice of Prior Distribution
339
184 Discussion
341
Numerical Computations for Group Sequential Tests
343
192 The Basic Calculation
344
193 Error Probabilities and Sample Size Distributions
349
194 Tests Defined by Error Spending Functions
351
195 Analysis Following a Group Sequential Test
353
196 Further Applications of Numerical Computation
355
197 Computer Software
358
References
361
Index
385
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