Adaptive design methods in clinical trials. (©2007)

• Record Type: Book
• Further Information: Note: Shein-Chung Chow, Mark Chang.
• Other Names: Chow, Shein-Chung, 1955-; Chang, Mark
• Contents: INTRODUCTION; What Is Adaptive Design; Regulatory Perspectives; Target Patient Population; Statistical Inference; Practical Issues; Aims and Scope of the Book; ; PROTOCOL AMENDMENT; Actual Patient Population; Estimation of Shift and Scale Parameters; Statistical Inference; Sample Size Adjustment; Statistical Inference with Covariate Adjustment; Concluding Remarks; ; ADAPTIVE RANDOMIZATION; Conventional Randomization; Treatment-Adaptive Randomization; Covariate-Adaptive Randomization; Response-Adaptive Randomization; Issues with Adaptive Randomization; Summary; ; ADAPTIVE HYPOTHESES; Modifications of Hypotheses; Switch from Superiority to Noninferiority; Concluding Remarks; ; ADAPTIVE DOSE-ESCALATION TRIALS; Introduction; CRM in Phase I Oncology Study; Hybrid Frequentist-Bayesian Adaptive Design; Simulations; Concluding Remarks; ; ADAPTIVE GROUP SEQUENTIAL DESIGN; Sequential Methods ; General Approach for Group Sequential Design; Early Stopping Boundaries; Alpha Spending Function; Group Sequential Design Based on Independent P-Values; Calculation of Stopping Boundaries; Group Sequential Trial Monitoring; Conditional Power; Practical Issues; ; ADAPTIVE SAMPLE SIZE ADJUSTMENT; Sample Size Re-Estimation without Unblinding Data; Cui-Hung-Wang's Method; Proschan-Hunsberger's Method; Muller-Schafer Method; Bauer-Köhne Method; Generalization of Independent P-Value Approaches; Inverse-Normal Method; Concluding Remarks; ; ADAPTIVE SEAMLESS PHASE II/III DESIGN; Why a Seamless Design Is Efficient; Step-wise Test and Adaptive Procedures; Contrast Test and Naive P-Value; Comparisons of Seamless Design; Drop-the-Loser Adaptive Design; Summary; ; ADAPTIVE TREATMENT SWITCHING; Latent Event Times; Proportional Hazard Model with Latent Hazard Rate; Mixed Exponential Model; Concluding Remarks; ; BAYESIAN APPROACH; Basic Concepts of Bayesian Approach; Multiple-Stage Design for Single-Arm Trial; Bayesian Optimal Adaptive Designs; Concluding Remarks; ; CLINICAL TRIAL SIMULATION; Simulation Framework; Early Phases Development; Late Phases Development; Software Application; Examples; Concluding Remarks; ; CASE STUDIES; Basic Considerations; Adaptive Group Sequential Design; Adaptive Dose-Escalation Design; Adaptive Seamless Phase II/III Design; ; SUBJECT INDEX; BIBLIOGRAPHY
• Publisher Details: Boca Raton, FL : Chapman & Hall/CRC
• Publication Date: 2007
• Copyright Date: 2007
• Extent: 1 online resource (277 pages), illustrations
• Subjects: 610.7/4; Clinical trials; Adaptive sampling (Statistics); Experimental design; Clinical trials -- Statistical methods; Clinical Trials -- methods; Research Design; Biometry -- methods; Models, Statistical; MEDICAL -- Education & Training; Adaptive sampling (Statistics); Clinical trials; Clinical trials -- Statistical methods; Experimental design; Electronic books
• Languages: English
• ISBNs: 9781584887775
• Related ISBNs: 158488777X; 1584887761; 9781584887768
• Notes: Note: Includes bibliographical references (pages 255-267) 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.