LEADER 04282oam 2200625I 450 001 9910799990703321 005 20230725020027.0 010 $a0-429-13066-X 010 $a1-283-00453-4 010 $a9786613004536 010 $a1-4398-1017-6 024 7 $a10.1201/b10279 035 $a(CKB)2560000000058169 035 $a(EBL)665619 035 $a(OCoLC)707067824 035 $a(SSID)ssj0000469781 035 $a(PQKBManifestationID)11312409 035 $a(PQKBTitleCode)TC0000469781 035 $a(PQKBWorkID)10526998 035 $a(PQKB)11393182 035 $a(MiAaPQ)EBC665619 035 $a(Au-PeEL)EBL665619 035 $a(CaPaEBR)ebr10447931 035 $a(CaONFJC)MIL300453 035 $a(EXLCZ)992560000000058169 100 $a20180331d2011 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aHandbook of adaptive designs in pharmaceutical and clinical development /$fedited by Annpey Pong, Shein-Chung Chow 210 1$aBoca Raton :$cCRC Press,$d2011. 215 $a1 online resource (475 p.) 300 $aDescription based upon print version of record. 311 $a1-4398-1016-8 320 $aIncludes bibliographical references and index. 327 $aFront cover; Contents; Preface; Editors; Contributors; Chapter 1. Overview of Adaptive Design Methods in Clinical Trials; Chapter 2. Fundamental Theory of Adaptive Designs with Unplanned Design Change in Clinical Trials with Blinded Data; Chapter 3. Bayesian Approach for Adaptive Design; Chapter 4. The Impact of Protocol Amendments in Adaptive Trial Designs; Chapter 5. From Group Sequential to Adaptive Designs; Chapter 6. Determining Sample Size for Classical Designs; Chapter 7. Sample Size Reestimation Design with Applications in Clinical Trials 327 $aChapter 8. Adaptive Interim Analyses in Clinical TrialsChapter 9. Classical Dose-Finding Trial; Chapter 10. Improving Dose-Finding: A Philosophic View; Chapter 11. Adaptive Dose-Ranging Studies; Chapter 12. Seamless Phase I/II Designs; Chapter 13. Phase II/III Seamless Designs; Chapter 14. Sample Size Estimation/Allocation for Two-Stage Seamless Adaptive Trial Designs; Chapter 15. Optimal Response-Adaptive Randomization for Clinical Trials; Chapter 16. Hypothesis-Adaptive Design; Chapter 17. Treatment Adaptive Allocations in Randomized Clinical Trials: An Overview 327 $aChapter 18. Integration of Predictive Biomarker Diagnostics into Clinical Trials for New Drug DevelopmentChapter 19. Clinical Strategy for Study Endpoint Selection; Chapter 20. Adaptive Infrastructure; Chapter 21. Independent Data Monitoring Committees; Chapter 22. Targeted Clinical Trials; Chapter 23. Functional Genome-Wide Association Studies of Longitudinal Traits; Chapter 24. Adaptive Trial Simulation; Chapter 25. Efficiency of Adaptive Designs; Chapter 26. Case Studies in Adaptive Design; Chapter 27. Good Practices for Adaptive Clinical Trials; Back cover 330 $aThis comprehensive guide offers a unified presentation of the principles and methodologies in adaptive design and analysis. It gives a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. The handbook provides some insight regarding early phase and later phase adaptive designs. With a focus on the implementation of adaptive methods in clinical trials, it introduces the concepts of role, responsibility, function, and activity of a data safety monitoring board (DSMB) when applying these methods. Other important topics covered in detail include regulatory perspectives and logistics issues in applying adaptive design methods--Provided by publisher. 606 $aClinical trials$vHandbooks, manuals, etc 606 $aDrugs$xResearch$xMethodology$vHandbooks, manuals, etc 615 0$aClinical trials 615 0$aDrugs$xResearch$xMethodology 676 $a615.5072/4 701 $aPong$b Annpey$01588269 701 $aChow$b Shein-Chung$f1955-$0254512 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910799990703321 996 $aHandbook of adaptive designs in pharmaceutical and clinical development$93877636 997 $aUNINA