## Group Sequential Methods with Applications to Clinical TrialsGroup 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 |

385 | |

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Group Sequential Methods with Applications to Clinical Trials Christopher Jennison,Bruce W. Turnbull Ingen forhåndsvisning tilgjengelig - 1999 |

### Vanlige uttrykk og setninger

accept achieve adaptive alternative analysis applied approach approximately attained boundary calculated Chapter clinical trials close comparing comparison computed conditional confidence intervals consider constants construct continue critical values decision defined denote depend described discuss early effect endpoints equal equivalence error probability error rate error spending estimate example final Fleming test follow function given gives group sequential test Imax increases information levels interim Jennison joint distribution known maximum mean methods monitoring needed normal Note null hypothesis O'Brien & Fleming observations obtained one-sided tests ordering outcome parameter patients planned Pocock possible power family prior problem procedure properties ratio RCIs reject repeated respectively response rule Section sequence shows similar specified stage standard statistics stopping subjects Suppose Table termination treatment treatment arm trial Turnbull two-sided tests Type I error variables variance

### Referanser til denne boken

Bioequivalence and Statistics in Clinical Pharmacology Scott D. Patterson,Byron Jones Begrenset visning - 2005 |

Common Errors in Statistics (and How to Avoid Them) Phillip I. Good,James W. Hardin Begrenset visning - 2006 |