| Description |
1 online resource (xxii, 418 pages) : illustrations |
| Series |
Chapman & Hall/CRC biostatistics series |
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Chapman & Hall/CRC biostatistics series
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| Contents |
PREFACE ; INTRODUCTION ; Motivation; Adaptive Design Methods in Clinical Trials; FAQs about Adaptive Designs; Road Map; Classic Design ; Overview of Drug Development; Two-Group Superiority and Noninferiority Designs; Two-Group Equivalence Trial; Dose-Response Trials; Maximum Information Design; Theory of Adaptive Design ; Introduction; General Theory; Design Evaluation-Operating Characteristics; Method with Direct Combination of P-values ; Method Based on Individual P-Values; Method Based on the Sum of P-Values; Method with Linear Combination of P-Values; Method with Product of P-Values; Event-Based Adaptive Design; Adaptive Design for Equivalence Trial; Method with Inverse-Normal P-values ; Method with Linear Combination of Z-Scores; Lehmacher and Wassmer Method; Classic Group Sequential Method; Cui-Hung-Wang Method |
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; Lan-DeMets Method; Fisher-Shen Method; Implementation of K-Stage Adaptive Designs ; Introduction; Nonparametric Approach; Error-Spending Approach; Conditional Error Function Method ; Proschan-Hunsberger Method; Denne Method; Müller-Schäfer Method; Comparison of Conditional Power; Adaptive Futility Design; Recursive Adaptive Design ; P-Clud Distribution; Two-Stage Design; Error-Spending and Conditional Error Principles; Recursive Two-Stage Design; Recursive Combination Tests; Decision Function Method; Sample Size REestimation design ; Opportunity; Adaptation Rules; SAS Macros for Sample Size Reesimation; Comparison of Sample Size Reesimation Methods; Analysis of Design with Sample Size Adjustment; Trial Example: Prevention of Myocardial Infarction; Multiple-Endpoint Adaptive design ; Multiplicity Issues |
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; Multiple-Endpoint Adaptive Design; Drop-Loser and Add-Arm Designs ; Opportunity; Method with Week Alpha-Control; Method with Strong Alpha-Control; Application of SAS Macro for Drop-Loser Design; Biomarker-Adaptive Design ; Opportunities; Design with Classifier Biomarker; Challenges in Biomarker Validation; Adaptive Design with Prognostic Biomarker; Adaptive Design with Predictive Marker; Adaptive Treatment Switching and Crossover ; Treatment Switching and Crossover; Mixed Exponential Survival Model; Threshold Regression; Latent Event Time Model for Treatment Crossover; Response-Adaptive Allocation Design ; Opportunities; Adaptive Design with RPW; General Response-Adaptive Randomization (RAR); Adaptive Dose Finding design ; Oncology Dose-Escalation Trial; Continual Reassessment Method (CRM); Bayesian Adaptive Design ; Introduction |
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; Bayesian Learning Mechanism; Bayesian Basics; Trial Design; Trial Monitoring; Analysis of Data; Interpretation of Outcomes; Regulatory Perspective; Planning, Execution, Analysis, |
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And Reporting ; Validity and Integrity; Study Planning; Working with Regulatory Agency; Trial Monitoring; Analysis and Reporting; Bayesian Approach; Clinical Trial Simulation; Paradox--Debates in Adaptive Designs ; My Standing Point; Decision Theory Basics; Evidence Measure; Statistical Principles; Behaviors of Statistical Principles in Adaptive Designs; Appendix A: Random Number Generation ; Random Number; Uniformly Distributed Random Number; Inverse CDF Method; Acceptance-Rejection Methods; Multivariate Distribution; Appendix B: Implementing Adaptive Designs in R ; Bibliography ; INDEX ; Summaries and Research Problems/Exercises appear at the end of each chapter |
| Bibliography |
Includes bibliographical references (pages 381-402) and index |
| Notes |
Print version record |
| SUBJECT |
SAS (Computer file) http://id.loc.gov/authorities/names/n88028236
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SAS (Computer file) fast |
| Subject |
Clinical trials -- Design
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Clinical trials -- Computer simulation
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Clinical trials -- Statistical methods
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Adaptive sampling (Statistics)
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R (Computer program language)
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Computer software.
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Computer programs.
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Clinical Trials as Topic -- methods
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Research Design
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Biometry -- methods
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Data Interpretation, Statistical
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Software
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software.
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MEDICAL -- Laboratory Medicine.
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Computer software
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Computer programs
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Adaptive sampling (Statistics)
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Clinical trials -- Design
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Clinical trials -- Statistical methods
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R (Computer program language)
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| Form |
Electronic book
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| ISBN |
9781584889632 |
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1584889632 |
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