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001    137289024 
003    OCoLC 
005    20210521141112.2 
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007    cr cnu---unuuu 
008    070531s2007    flua    ob    001 0 eng d 
020    9781584887775 
020    158488777X 
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100 1  Chow, Shein-Chung,|d1955- 
245 10 Adaptive design methods in clinical trials /|cShein-Chung 
       Chow, Mark Chang. 
260    Boca Raton, FL :|bChapman & Hall/CRC,|c©2007. 
300    1 online resource (277 pages) :|billustrations 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
490 1  Chapman & Hall/CRC biostatistics series ;|v17 
504    Includes bibliographical references (pages 255-267) and 
       index. 
505 0  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 
505 0  ; 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 
505 0  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 
506    Available only to authorized UTEP users. 
520    Although adaptive design methods are flexible and useful 
       in clinical research, little or no regulatory guidelines 
       are available. One of the first books on the topic, 
       "Adaptive Design Methods in Clinical Trials" presents the 
       principles and methodologies in adaptive design and 
       analysis that pertain to adaptations made to trial or 
       statistical procedures that are based on accrued data of 
       ongoing clinical trials. The book also offers a well-
       balanced summary of current regulatory perspectives and 
       recently developed statistical methods in this area. After
       an introduction to basic concepts and statistical 
       considerations of adaptive design methods, the book 
       questions the impact on target patient populations as the 
       result of protocol amendments and discusses the 
       generalization of statistical inference. The authors also 
       present various adaptive design methods, including where 
       hypotheses are modified during the conduct of clinical 
       trials, for dose selection, and commonly used adaptive 
       group sequential design methods in clinical trials.; 
       Following a discussion of blind procedures for sample size
       re-estimation, the book describes statistical tests for 
       seamless phase II/III adaptive designs and statistical 
       inference for switching adaptively from one treatment to 
       another. The book concludes with computer simulations and 
       various case studies of clinical trials. By providing 
       theoretical and computer simulation results, method 
       comparisons, and practical guidelines for choosing an 
       optimal design, "Adaptive Design Methods in Clinical 
       Trials" fills the need for a unified, comprehensive, and 
       updated resource in the clinical research and development 
       of adaptive design and analysis 
588 0  Print version record. 
650  0 Clinical trials. 
650  0 Adaptive sampling (Statistics) 
650  0 Experimental design. 
650  0 Clinical trials|xStatistical methods. 
650 12 Clinical Trials|xmethods 
650 12 Research Design. 
650 22 Biometry|xmethods. 
650 22 Models, Statistical. 
700 1  Chang, Mark. 
776 08 |iPrint version:|aChow, Shein-Chung, 1955-|tAdaptive 
       design methods in clinical trails.|dBoca Raton, FL : 
       Chapman & Hall/CRC, ©2007|z1584887761|z9781584887768
       |w(DLC)  2006048510|w(OCoLC)70408042 
830  0 Chapman & Hall/CRC biostatistics series ;|v17. 
856 40 |uhttp://0-search.ebscohost.com.lib.utep.edu/
       login.aspx?direct=true&scope=site&db=nlebk&AN=189362|zTo 
       access this resource 
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