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" Randomization in clinical trials : "
William F. Rosenberger, John M. Lachin
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BL
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662125
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dltt
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| Main Entry
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Rosenberger, William F.
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| Title & Author
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Randomization in clinical trials : : theory and practice /\ William F. Rosenberger, John M. Lachin
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| Series Statement
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Wiley series in probability and statistics
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| Page. NO
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1 online resource
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| ISBN
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9781118742372 (ePub)
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: 1118742370 (ePub)
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: 9781118742150 (Adobe PDF)
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: 111874215X (Adobe PDF)
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9781118742242 (cloth)
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: 9781118742112
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: 1118742117
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1118742249 (cloth)
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| Bibliographies/Indexes
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Includes bibliographical references and indexes
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| Contents
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Randomization and the Clinical Trial -- Introduction -- Causation and Association -- Randomized Clinical Trials -- Ethics of Randomization -- Problems -- References -- Issues in the Design of Clinical Trials -- Introduction -- Study Outcomes -- Sources of Bias -- Selection and ascertainment bias -- Statistical analysis philosophy -- Losses to follow-up and noncompliance -- Covariates -- Experimental Design -- Recruitment and Follow-Up -- Determining the Number of Randomized Subjects -- Development of the main formula -- Example -- Survival trials -- Adjustment for noncompliance -- Additional considerations -- Problems -- References -- Randomization for Balancing Treatment Assignments -- Introduction -- Complete Randomization -- Forced Balance Procedures -- Random allocation rule -- Truncated binomial design -- Hadamard randomization -- Maximal procedure -- Forced Balance Randomization Within Blocks -- Permuted block design -- Random block design -- Efron's Biased Coin Design -- Other Biased Coin Designs and Generalizations -- Wei's Urn Design -- Other urn Models and Generalizations -- Comparison of Balancing Properties -- Restricted Randomization for Unbalanced Allocation -- K>2 Treatments -- Problems -- References -- Appendix -- The Effects of Unobserved Covariates -- Introduction -- A Bound on the Probability of a Covariate -- Simulation Results -- Accidental Bias -- Maximum Eigenvalue of Σt -- Accidental Bias for Biased Coin Designs -- Chronological Bias -- Problems -- References -- Appendix -- Selection Bias -- Introduction -- The BlackweD-Hodges Model -- Predictability of a Randomization Sequence -- Selection Bias for the Random Allocation Rule and Truncated Binomial Design -- Selection Bias in a Permuted Block Design -- Permuted blocks using the random allocation rule -- Permuted blocks with truncated binomial randomization -- Random block design -- Conclusions -- Selection Bias for Other Restricted Randomization Procedures -- Efron's biased coin design -- Wei's urn design -- Smith's design -- Simulation Results -- Controlling and Testing for Selection Bias in Practice -- Problems -- References -- Appendix -- Randomization as a Basis for Inference -- Introduction -- The Population Model -- The Randomization Model -- Randomization Tests -- Linear Rank Tests -- Variance of the Linear Rank Test -- Optimal Rank Scores -- Exact and Large-Sample Randomization Tests -- Computation of exact tests -- Large sample randomization tests -- Monte Carlo Re-Randomization Tests -- Unconditional tests -- Example -- Conditional tests -- Preservation of Error Rates -- Regression Modeling -- Analyses with Missing Data -- Sample Size Considerations for Random Sample Fractions -- Group Sequential Monitoring -- Establishing a stopping boundary -- Information fraction -- Problems -- References -- Appendix A -- Appendix B -- Stratification -- Introduction -- Stratified Randomization -- Is Stratification Necessary? -- Treatment Imbalances in Stratified Trials -- Stratified Analysis Using Randomization Tests -- Efficiency of Stratified Randomization in a Stratified Analysis -- Conclusions -- Problems -- References -- Restricted Randomization in Practice -- Introduction -- Stratification -- Characteristics of Randomization Procedures -- Consideration of selection bias -- Implications for analysis -- Selecting a Randomization Procedure -- Choosing parameter values -- Comparing procedures -- Conclusions -- Generation of Sequences -- Implementation -- Packaging and labeling -- The actual randomization -- Special Situations -- Some Examples -- The optic neuritis treatment trial -- Vesnarinone in congestive heart failure -- The diabetes control and complications trial -- Captopril in diabetic nephropathy -- The diabetes prevention program -- Scleral buckling versus primary vitrectomy in retinal detachment (The SPR Study) -- Problems -- References -- Covariate-Adaptive Randomization -- Early Work -- Zelen's rule -- The Pocock-Simon procedure -- Example: Adjuvant chemotherapy for locally invasive bladder cancer -- Wei's marginal urn design -- Is marginal balance sufficient? -- Is randomization necessary? -- More Recent Covariate-Adaptive Randomization Procedures -- Balancing within strata -- Balancing with respect to continuous covariates -- Optimal Design Based on a Linear Model -- The Trade-Off Among Balance, Efficiency, and Ethics -- Inference for Covariate-Adaptive Randomization -- Model-based inference -- Randomization-based inference -- Conclusions -- Problems -- References -- Response-Adaptive Randomization -- Introduction -- Historical Notes -- Roots in bandit problems -- Roots in sequential stopping problems -- Roots in randomization -- Optimal Allocation -- Response-Adaptive Randomization to Target R* -- Sequential maximum likelihood procedure -- Doubly adaptive biased coin design -- Example -- Efficient randomized-adaptive design -- Urn Models -- The generalized Friedman's urn model -- The randomized play-the-winner rule -- Designs to target any allocation -- Ternary urn models -- Klein urn -- Treatment Effect Mappings -- Covariate-Adjusted Response-Adaptive Randomization -- Problems -- References -- Appendix -- Inference for Response-Adaptive Randomization -- Introduction -- Population-Based Inference -- The likelihood -- Sufficiency -- Bias of the maximum likelihood estimators -- Confidence interval procedures -- Power -- The relationship between power and the variability of the design -- Asymptotically best procedures -- Response-adaptive randomization and sequential monitoring -- Randomization-Based Inference -- Problems -- References -- Response-Adaptive Randomization in Practice -- Basic Assumptions -- Bias, Masking, and Consent -- Logistical Issues -- Selection of A Procedure -- Benefits of Response-Adaptive Randomization -- Some Examples -- The extracorporeal membrane oxygenation trial -- The fluoxetine trial -- Conclusions -- Problems -- References
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| Subject
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Clinical trials.
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Sampling (Statistics)
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| Dewey Classification
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610.72/4
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| LC Classification
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R853.C55
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| NLM classification
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W 20.55.C5
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| Added Entry
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Lachin, John M.,1942-
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| Added Entry
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Ohio Library and Information Network.
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