LEADER 00000cam  2200853 a 4500 
001    798437925 
003    OCoLC 
005    20200814215037.3 
006    m     o  d         
007    cr un|---uuuuu 
008    120705s2013    nju     ob    001 0 eng   
010    2012027524 
020    9781118458143|q(ePub) 
020    1118458141|q(ePub) 
020    9781118458099|q(MobiPocket) 
020    1118458095|q(MobiPocket) 
020    9781118458136|q(Adobe PDF) 
020    1118458133|q(Adobe PDF) 
020    1118458168|q(electronic bk.) 
020    9781118458167|q(electronic bk.) 
020    0470887656 
020    9780470887653 
020    9781306133579|q(MyiLibrary) 
020    1306133572|q(MyiLibrary) 
020    |z9780470887653|q(cloth) 
035    (OCoLC)798437925|z(OCoLC)871193330|z(OCoLC)897584259
       |z(OCoLC)903290396|z(OCoLC)992822982 
035    Ebook Central DDA Titles 
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050 00 R853.S7eb 
072  7 HEA|x012000|2bisacsh 
072  7 HEA|x020000|2bisacsh 
072  7 MED|x004000|2bisacsh 
072  7 MED|x101000|2bisacsh 
072  7 MED|x109000|2bisacsh 
072  7 MED|x029000|2bisacsh 
072  7 MED|x040000|2bisacsh 
072  7 MED|x092000|2bisacsh 
100 1  Chow, Shein-Chung,|d1955- 
245 10 Design and analysis of clinical trials :|bconcepts and 
       methodologies /|cShein-Chung Chow, Jen-Pei Liu. 
250    3rd ed. 
260    Hoboken, N.J. :|bWiley,|c©2013. 
300    1 online resource 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
500    Includes index. 
504    Includes bibliographical references and index. 
505 00 |gMachine generated contents note:|gpt. I|tPRELIMINARIES -
       -|g1.|tIntroduction --|g1.1.|tWhat are Clinical Trials? --
       |g1.2.|tHistory of Clinical Trials --|g1.3.|tRegulatory 
       Process and Requirements --|g1.4.|tInvestigational New 
       Drug Application --|g1.5.|tNew Drug Application --|g1.6.
       |tClinical Development and Practice --|g1.7.|tAIMS and 
       Structure of the Book --|g2.|tBasic Statistical Concepts -
       -|g2.1.|tIntroduction --|g2.2.|tUncertainty and 
       Probability --|g2.3.|tBias and Variability --|g2.4.
       |tConfounding and Interaction --|g2.5.|tDescriptive and 
       Inferential Statistics --|g2.6.|tHypotheses Testing and p-
       Values --|g2.7.|tClinical Significance and Clinical 
       Equivalence --|g2.8.|tReproducibility and Generalizability
       --|g3.|tBasic Design Considerations --|g3.1.|tIntroduction
       --|g3.2.|tGoals of Clinical Trials --|g3.3.|tTarget 
       Population and Patient Selection --|g3.4.|tSelection of 
       Controls --|g3.5.|tStatistical Considerations --|g3.6.
       |tOther Issues --|g3.7.|tDiscussion --|g4.|tRandomization 
       and Blinding --|g4.1.|tIntroduction --|g4.2.
       |tRandomization Models --|g4.3.|tRandomization Methods --
       |g4.4.|tImplementation of Randomization --|g4.5.
       |tGeneralization of Controlled Randomized Trials --|g4.6.
       |tBlinding --|g4.7.|tDiscussion --|gpt. II|tDESIGNS AND 
       THEIR CLASSIFICATIONS --|g5.|tDesigns for Clinical Trials 
       --|g5.1.|tIntroduction --|g5.2.|tParallel Group Designs --
       |g5.3.|tClustered Randomized Designs --|g5.4.|tCrossover 
       Designs --|g5.5.|tTitration Designs --|g5.6.|tEnrichment 
       Designs --|g5.7.|tGroup Sequential Designs --|g5.8.
       |tPlacebo-Challenging Designs --|g5.9.|tBlinded Reader 
       Designs --|g5.10.|tDiscussion --|g6.|tDesigns for Cancer 
       Clinical Trials --|g6.1.|tIntroduction --|g6.2.|tGeneral 
       Considerations for Phase I Cancer Clinical Trials --|g6.3.
       |tSingle-Stage Up-and-Down Phase I Designs --|g6.4.|tTwo-
       Stage Up-and-Down Phase I Designs --|g6.5.|tContinual 
       Reassessment Method Phase I Designs --|g6.6.|tOptimal and 
       Flexible Multiple-Stage Designs --|g6.7.|tRandomized Phase
       II Designs --|g6.8.|tDiscussion --|g7.|tClassification of 
       Clinical Trials --|g7.1.|tIntroduction --|g7.2.
       |tMulticenter Trials --|g7.3.|tSuperiority Trials --|g7.4.
       |tActive Control and Equivalence/Noninferiority Trials --
       |g7.5.|tDose-Response Trials --|g7.6.|tCombination Trials 
       --|g7.7.|tBridging Studies and Global Trials --|g7.8.
       |tVaccine Clinical Trials --|g7.9.|tQT Studies --|g7.10.
       |tDiscussion --|gpt. III|tANALYSIS OF CLINICAL DATA --|g8.
       |tAnalysis of Continuous Data --|g8.1.|tIntroduction --
       |g8.2.|tEstimation --|g8.3.|tTest Statistics --|g8.4.
       |tAnalysis of Variance --|g8.5.|tAnalysis of Covariance --
       |g8.6.|tNonparametric Methods --|g8.7.|tRepeated Measures 
       --|g8.8.|tDiscussion --|g9.|tAnalysis of Categorical Data 
       --|g9.1.|tIntroduction --|g9.2.|tStatistical Inference for
       One Sample --|g9.3.|tInference of Independent Samples --
       |g9.4.|tOrdered Categorical Data --|g9.5.|tCombining 
       Categorical Data --|g9.6.|tModel-Based Methods --|g9.7.
       |tRepeated Categorical Data --|g9.8.|tDiscussion --|g10.
       |tCensored Data and Interim Analysis --|g10.1.
       |tIntroduction --|g10.2.|tEstimation of the Survival 
       Function --|g10.3.|tComparison Between Survival Functions 
       --|g10.4.|tCox's Proportional Hazard Model --|g10.5.
       |tCalendar Time and Information Time --|g10.6.|tGroup 
       Sequential Methods --|g10.7.|tDiscussion --|g11.|tSample 
       Size Determination --|g11.1.|tIntroduction --|g11.2.
       |tBasic Concept --|g11.3.|tTwo Samples --|g11.4.|tMultiple
       Samples --|g11.5.|tCensored Data --|g11.6.|tDose-Response 
       Studies --|g11.7.|tCrossover Designs --|g11.8.
       |tEquivalence and Noninferiority Trials --|g11.9.
       |tMultiple-Stage Design in Cancer Trials --|g11.10.
       |tMultinational Trials --|g11.11.|tComparing Variabilities
       --|g11.12.|tDiscussion --|gpt. IV|tISSUES IN EVALUATION --
       |g12.|tIssues in Efficacy Evaluation --|g12.1.
       |tIntroduction --|g12.2.|tBaseline Comparison --|g12.3.
       |tIntention-to-Treat Principle and Efficacy Analysis --
       |g12.4.|tAdjustment for Covariates --|g12.5.|tMulticenter 
       Trials --|g12.6.|tMultiplicity --|g12.7.|tData Monitoring 
       --|g12.8.|tUse of Genetic Information for Evaluation of 
       Efficacy --|g12.9.|tSample Size Reestimation --|g12.10.
       |tDiscussion --|g13.|tSafety Assessment --|g13.1.
       |tIntroduction --|g13.2.|tExtent of Exposure --|g13.3.
       |tCoding of Adverse Events --|g13.4.|tAnalysis of Adverse 
       Events --|g13.5.|tAnalysis of Laboratory Data --|g13.6.
       |tAnalysis of QT/QTc Prolongation --|g13.7.|tDiscussion --
       |gpt. V|tRECENT DEVELOPMENT --|g14.|tBiomarkers and 
       Targeted Clinical Trials --|g14.1.|tIntroduction --|g14.2.
       |tConcepts and Strategies --|g14.3.|tBiomarker Development
       and Validation --|g14.4.|tDesigns of Targeted Clinical 
       Trials --|g14.5.|tAnalyses of Targeted Clinical Trials --
       |g14.6.|tDiscussion --|g15.|tTrials for Evaluating 
       Accuracy of Diagnostic Devices --|g15.1.|tIntroduction --
       |g15.2.|tStudy Design --|g15.3.|tMeasures of Diagnostic 
       Accuracy --|g15.4.|tReporting Results --|g15.5.|tSample 
       Size Estimation --|g15.6.|tDiscussion --|g16.|tStatistical
       Methods in Translational Medicine --|g16.1.|tIntroduction 
       --|g16.2.|tBiomarker Development --|g16.3.|tBench-to-
       Bedside --|g16.4.|tAnimal Model Versus Human Model --
       |g16.5.|tTranslation in Study Endpoints --|g16.6.
       |tBridging Studies --|g16.7.|tDiscussion --|g16.8.
       |tAppendix --|g17.|tAdaptive Clinical Trial Designs --
       |g17.1.|tIntroduction --|g17.2.|tWhat Is Adaptive Design? 
       --|g17.3.|tWell-Understood and Less Well-Understood 
       Designs --|g17.4.|tClinical/Statistical and Regulatory 
       Perspectives --|g17.5.|tImpact of Protocol Amendments --
       |g17.6.|tChallenges in By-Design Adaptations --|g17.7.
       |tObstacles of Retrospective Adaptations --|g17.8.
       |tDiscussion --|g18.|tTraditional Chinese Medicine --
       |g18.1.|tIntroduction --|g18.2.|tFundamental Differences -
       -|g18.3.|tBasic Considerations of TCM Clinical Trials --
       |g18.4.|tOther Issues in TCM Research and Development --
       |g18.5.|tConsortium for Globalization of Traditional 
       Chinese Medicine --|g18.6.|tDiscussion --|gpt. VI|tCONDUCT
       OF CLINICAL TRIALS --|g19.|tPreparation and Implementation
       of a Clinical Protocol --|g19.1.|tIntroduction --|g19.2.
       |tStructure and Components of a Protocol --|g19.3.|tPoints
       to be Considered and Common Pitfalls During Development 
       and Preparation of a Protocol --|g19.4.|tCommon Departures
       for Implementation of a Protocol --|g19.5.|tMonitoring, 
       Audit, and Inspection --|g19.6.|tQuality Assessment of a 
       Clinical Trial --|g19.7.|tDiscussion --|g20.|tData 
       Management of a Clinical Trial --|g20.1.|tIntroduction --
       |g20.2.|tRegulatory Requirements --|g20.3.|tDevelopment of
       Case Report Forms --|g20.4.|tDatabase Development --
       |g20.5.|tData Entry, Query, and Correction --|g20.6.|tData
       Validation and Quality --|g20.7.|tDatabase Lock, Archive, 
       and Transfer --|g20.8.|tCritical Issues. 
506    Available only to authorized UTEP users. 
520    Praise for the Second Edition: " ... a grand feast for 
       biostatisticians. It stands ready to satisfy the appetite 
       of any pharmaceutical scientist with a respectable 
       statistical appetite."--Journal of Clinical Research Best 
       Practices The Third Edition of Design and Analysis of 
       Clinical Trials provides complete, comprehensive, and 
       expanded coverage of recent health treatments and 
       interventions. Featuring a unified presentation, the book 
       provides a well-balanced summary of current regulatory 
       requirements and recently developed statistical methods as
       well as. 
588 0  Print version record and CIP data provided by publisher. 
650  0 Clinical trials|xMethodology. 
650  0 Clinical trials|xStatistical methods. 
650  2 Clinical Trials as Topic|xmethods. 
650  2 Research Design. 
700 1  Liu, Jen-pei,|d1952- 
776 08 |iPrint version:|aChow, Shein-Chung, 1955-|tDesign and 
       analysis of clinical trials.|b3rd ed.|dHoboken, N.J. : 
       John Wiley & Sons, ©2013|z9780470887653|w(DLC)  2012020270
856 40 |uhttp://0-ebookcentral.proquest.com.lib.utep.edu/lib/utep
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