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Title Controversial Statistical Issues in Clinical Trials.
Imprint Hoboken : Chapman & Hall/CRC, 2011.


 Internet  Electronic Book    AVAILABLE
Description 1 online resource (598 pages)
Series Chapman & Hall/CRC Biostatistics Series
Chapman & Hall/CRC biostatistics series.
Note Available only to authorized UTEP users.
Print version record.
Subject Drugs -- Testing.
Drug development.
Clinical trials.
Contents Front Cover -- Contents -- Preface -- Chapter 1: Introduction -- Chapter 2: Good Statistical Practices -- Chapter 3: Bench-to-Bedside Translational Research -- Chapter 4: Bioavailability and Bioequivalence -- Chapter 5: Hypotheses for Clinical Evaluation and Significant Digits -- Chapter 6: Instability of Sample Size Calculation -- Chapter 7: Integrity of Randomization/Blinding -- Chapter 8: Clinical Strategy for Endpoint Selection -- Chapter 9: Protocol Amendments -- Chapter 10: Seamless Adaptive Trial Designs -- Chapter 11: Multiplicity in Clinical Trials -- Chapter 12: Independence of Data Monitoring Committee -- Chapter 13: Two-Way ANOVA versus One-Way ANOVA with Repeated Measures -- Chapter 14: Validation of QOL Instruments -- Chapter 15: Missing Data Imputation -- Chapter 16: Center Grouping -- Chapter 17: Non-Inferiority Margin -- Chapter 18: QT Studies with Recording Replicates -- Chapter 19: Multiregional Clinical Trials -- Chapter 20: Dose Escalation Trials -- Chapter 21: Enrichment Process in Target Clinical Trials -- Chapter 22: Clinical Trial Simulation -- Chapter 23: Traditional Chinese Medicine -- Chapter 24: The Assessment of Follow-On Biologic Products -- Chapter 25: Generalizability/Reproducibility Probability -- Chapter 26: Good Review Practices -- Chapter 27: Probability of Success -- References -- Back Cover.
Summary In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. The book focuses on issues occurring at various stages of clinical research and development, includi.
Other Title Print version: Chow, Shein-Chung. Controversial Statistical Issues in Clinical Trials. Hoboken : Chapman & Hall/CRC, ©2011 9781439849613