Controversial Statistical Issues in Clinical Trials

Shein-Chung Chow, Ph.D., is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also an adjunct professor of clinical sciences at Duke–National University of Singapore Graduate Medical School and the editor-in-chief of the Journal of Biopharmaceutical Statistics. He has authored or co-authored more than 200 papers and 19 books, including the recently published Handbook of Adaptive Designs in Pharmaceutical and Clinical Development. He earned his Ph.D. in statistics from the University of Wisconsin–Madison.

Introduction. Good Statistical Practices. Bench-to-Bedside Translational Research. Bioavailability and Bioequivalence. Hypotheses for Clinical Evaluation and Significant Digits. Instability of Sample Size Calculation. Integrity of Randomization/Blinding. Clinical Strategy for Endpoint Selection. Protocol Amendments. Seamless Adaptive Trial Designs. Multiplicity in Clinical Trials. Independence of Data Monitoring Committee. Two-Way ANOVA versus One-Way ANOVA with Repeated Measures. Validation of QOL Instruments. Missing Data Imputation. Center Grouping. Non-Inferiority Margin. QT Studies with Recording Replicates. Multiregional Clinical Trials. Dose Escalation Trials. Enrichment Process in Target Clinical Trials. Clinical Trial Simulation. Traditional Chinese Medicine. The Assessment of Follow-On Biologic Products. Generalizability/Reproducibility Probability. Good Review Practices. Probability of Success. References. Index.