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001    750172564 
003    OCoLC 
005    20200921044458.5 
006    m     o  d         
007    cr cnu---unuuu 
008    110907s2011    flua    ob    001 0 eng d 
020    9781439849620 
020    1439849625 
035    Taylor & Francis All eBooks 
035    (OCoLC)750172564|z(OCoLC)1015206713|z(OCoLC)1066020301 
035    skip4alma 
037    TANDF_224252|bIngram Content Group 
040    N$T|beng|epn|cN$T|dYDXCP|dOCLCQ|dCUS|dOCLCQ|dGPM|dOCLCQ
049    txum 
050  4 RM301.27|b.C475 2011eb 
072  7 HEA|x009000|2bisacsh 
072  7 MED|x034000|2bisacsh 
072  7 OCC|x011000|2bisacsh 
072  7 HEA|x032000|2bisacsh 
082 04 615.5072/4|223 
100 1  Chow, Shein-Chung,|d1955- 
245 10 Controversial statistical issues in clinical trials /
       |cShein-Chung Chow. 
260    Boca Raton :|bCRC Press,|c©2011. 
300    1 online resource (xix, 591 pages) :|billustrations 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
490 1  Chapman & Hall/CRC biostatistics series 
504    Includes bibliographical references (pages 553-575) and 
505 0  Introduction; Pharmaceutical Development; Controversial 
       Issues; Aim and Structure of the Book Good Statistical 
       Practices ; Statistical Principles; Good Statistical 
       Practices in Europe; Implementation of GSP Bench-to-
       Bedside Translational Research ; Biomarker Development; 
       One-Way/Two-Way Translational Process; Lost in 
       Translation; Animal Model versus Human Model 
       Bioavailability and Bioequivalence; Bioequivalence 
       Assessment; Drug Interchangeability; Controversial Issues;
       Frequently Asked Questions Hypotheses for Clinical 
       Evaluation and Significant Digits; Hypotheses for Clinical
       Evaluation; Statistical Methods for Testing Composite 
       Hypotheses of NS; The Impact on Power and Sample Size 
       Calculation; Significant Digits Instability of Sample Size
       Calculation ; Sample Size 
505 0  Calculation; Instability and Bootstrap-Median Approach; 
       Simulation Study; An Example Integrity of Randomization/
       Blinding ; The Effect of Mixed-Up Randomization; Blocking 
       Size in Randomization; Test for Integrity of Blinding; 
       Analysis under Breached Blindness; An Example Clinical 
       Strategy for Endpoint Selection ; Clinical Strategy for 
       Endpoint Selection; Translations among Clinical Endpoints;
       Comparison of Different Clinical Strategies; A Numerical 
       Study Protocol Amendments ; Moving Target Patient 
       Population; Analysis with Covariate Adjustment; Assessment
       of Sensitivity Index; Sample Size Adjustment Seamless 
       Adaptive Trial Designs ; Controversial Issues; Types of 
       Two-Stage Seamless Adaptive Designs; Analysis for Seamless
       Design with Same Study Objectives/Endpoints; Analysis for 
       Seamless Design with Different Endpoints; Analysis 
505 0  For Seamless Design with Different Objectives/Endpoints 
       Multiplicity in Clinical Trials ; General Concept; 
       Regulatory Perspective and Controversial Issues; 
       Statistical Method for Adjustment of Multiplicity; 
       Gatekeeping Procedures Independence of Data Monitoring 
       Committee ; Regulatory Requirements; DMC Composition and 
       Charter; DMC's Functions and Activities; Independence of 
       DMC Two-Way ANOVA versus One-Way ANOVA with Repeated 
       Measures ; One-Way ANOVA with Repeated Measures; Two-Way 
       ANOVA; Statistical Evaluation; Simulation Study; An 
       Example; Discussion Validation of QOL Instruments ; QOL 
       Assessment; Performance Characteristics; Responsiveness 
       and Sensitivity; Utility Analysis and Calibration; 
       Analysis of Parallel Questionnaire; An Example Missing 
       Data Imputation ; Last Observation Carry 
505 0  Forward; Mean/Median Imputation; Regression Imputation; 
       Marginal/Conditional Imputation for Contingency; Testing 
       for Independence; Controversial Issues; Recent Development
       Center Grouping ; Selection of the Number of Centers; 
       Impact of Treatment Imbalance on Power; Center Grouping; 
       Procedure for Center Grouping; An Example Non-Inferiority 
       Margin ; Non-Inferiority Margin; Statistical Test Based on
       Treatment Difference; Statistical Tests Based on Relative 
       Risk; Mixed Non-Inferiority Margin; Recent Developments QT
       Studies with Recording Replicates ; Study Designs and 
       Models; Power and Sample Size Calculation; Adjustment for 
       Covariates; Optimization for Sample Size Allocation; Test 
       for QT/QTc Prolongation; Recent Developments Multiregional
       Clinical Trials ; Multiregional (Multinational), 
505 0  Multicenter Trials; Selection of the Number of Sites; 
       Sample Size Calculation and Allocation; Statistical 
       Methods for Bridging Studies Dose Escalation Trials ; 
       Traditional Escalation Rule; Continual Reassessment 
       Method; Design Selection and Sample Size Enrichment 
       Process in Target Clinical Trials ; Identification of 
       Differentially Expressed Genes; Optimal Representation of 
       In Vitro Diagnostic Multivariate Index Assays; Validation 
       of In Vitro Diagnostic Multivariate Index Assays; 
       Enrichment Process; Study Designs of Target Clinical 
       Trials; Analysis of Target Clinical Trials; Discussion 
       Clinical Trial Simulation ; Process for Clinical Trial 
       Simulation; EM Algorithm; Resampling Method: 
       Bootstrapping; Clinical Applications Traditional Chinese 
       Medicine ; Fundamental Differences; Basic Considerations; 
       Controversial Issues; Recent 
505 0  Development The Assessment of Follow-On Biologic Products 
       ; Regulatory Requirements; Criteria for Biosimilarity; 
       Scientific Issues; Assessing Similarity Using Genomic Data
       Generalizability/Reproducibility Probability ; The 
       Estimated Power Approach; The Confidence Bound Approach; 
       The Bayesian Approach; Applications Good Review Practices 
       ; Regulatory Process and Requirements; Good Review 
       Practices; Obstacles and Challenges Probability of Success
       ; Go/No-Go Decision in Development Process; POS Assessment
       References Index 
506    Available only to authorized UTEP users. 
520    "Preface In pharmaceutical/clinical development of a test 
       drug or treatment, relevant clinical data are usually 
       collected from subjects with the diseases under study in 
       order to evaluate safety and efficacy of the test drug or 
       treatment under investigation. To provide accurate and 
       reliable assessment, well-controlled clinical trials under
       valid study design are necessarily conducted. Clinical 
       trial process is a lengthy and costly process, which is 
       necessary to ensure a fair and reliable assessment of the 
       test treatment under investigation. Clinical trial process
       consists of protocol development, trial conduct, data 
       collection, statistical analysis/interpretation, and 
       reporting. In practice, controversial issues evitably 
       occur regardless the compliance of good statistical 
       practice (GSP) and good clinical practice (GCP). 
       Controversial issues in clinical trials are referred to as
       debatable issues that are commonly encountered during the 
       conduct of clinical trials. In practice, controversial 
       issues could be raised from, but are not limited to, (1) 
       compromises between theoretical and real/common practices,
       (2) miscommunication and/or misunderstanding in perception
       /interpretation among regulatory agencies, clinical 
       scientists, and biostatisticians, and (3) disagreement, 
       inconsistency, miscommunication/misunderstanding, and 
       errors in clinical practice."--|cProvided by publisher. 
588 0  Print version record. 
650  0 Drugs|xTesting. 
650  0 Drug development. 
650  0 Clinical trials. 
650 12 Clinical Trials as Topic. 
650 12 Drug Evaluation, Preclinical. 
650 22 Data Interpretation, Statistical. 
776 08 |iPrint version:|aChow, Shein-Chung, 1955-|tControversial 
       statistical issues in clinical trials.|dBoca Raton : CRC 
       Press, ©2011|z9781439849613|w(DLC)  2011024204
830  0 Chapman & Hall/CRC biostatistics series. 
856 40 |uhttp://0-www.taylorfrancis.com.lib.utep.edu/books/
       9780429063497|zTo access this resource 
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