Controversial statistical issues in clinical trials. (©2011)

• Record Type: Book
• Further Information: Note: Shein-Chung Chow.
• Other Names: Chow, Shein-Chung, 1955-
• Contents: 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 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 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 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), 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 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
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2011
• Copyright Date: 2011
• Extent: 1 online resource (xix, 591 pages), illustrations
• Subjects: 615.5072/4; Drugs -- Testing; Drug development; Clinical trials; Clinical Trials as Topic; Drug Evaluation, Preclinical; Data Interpretation, Statistical; BODY, MIND & SPIRIT -- Healing -- General; HEALTH & FITNESS -- Alternative Therapies; HEALTH & FITNESS -- Healing; MEDICAL -- Healing; Clinical trials; Drug development; Drugs -- Testing; Electronic books
• Languages: English
• ISBNs: 9781439849620; 1439849625
• Related ISBNs: 9781439849613; 1439849617
• Notes: Note: Includes bibliographical references (pages 553-575) 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.