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Title Controversial statistical issues in clinical trials / Shein-Chung Chow.
Imprint Boca Raton : CRC Press, ©2011.

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Description 1 online resource (xix, 591 pages) : illustrations
Series Chapman & Hall/CRC biostatistics series
Chapman & Hall/CRC biostatistics series.
Bibliog. Includes bibliographical references (pages 553-575) and index.
Note Available only to authorized UTEP users.
Print version record.
Subject Drugs -- Testing.
Drug development.
Clinical trials.
Clinical Trials as Topic.
Drug Evaluation, Preclinical.
Data Interpretation, Statistical.
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
Summary "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."-- Provided by publisher.
Other Title Print version: Chow, Shein-Chung, 1955- Controversial statistical issues in clinical trials. Boca Raton : CRC Press, ©2011 9781439849613