Adaptive design theory and implementation using SAS and R. (©2008)

• Record Type: Book
• Further Information: Note: Mark Chang.
• Other Names: Chang, Mark
• 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 ; 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 ; 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 ; Bayesian Learning Mechanism; Bayesian Basics; Trial Design; Trial Monitoring; Analysis of Data; Interpretation of Outcomes; Regulatory Perspective; Planning, Execution, Analysis, 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.
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2008
• Copyright Date: 2008
• Extent: 1 online resource (xxii, 418 pages), illustrations
• Subjects: 610.72/4; Clinical trials -- Design; Clinical trials -- Computer simulation; Clinical trials -- Statistical methods; Adaptive sampling (Statistics); R (Computer program language); Clinical Trials as Topic -- methods; Research Design; Biometry -- methods; Data Interpretation, Statistical; Software; MEDICAL -- Laboratory Medicine; Electronic books
• Languages: English
• ISBNs: 9781584889632; 1584889632
• Related ISBNs: 9781584889625; 1584889624
• Notes: Note: Includes bibliographical references (pages 381-402) and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.