Shein-Chung Chow

Controversial Statistical Issues in Clinical Trials (eBook, PDF)

• Format: PDF

Produktbeschreibung

Written by one of the preeminent experts in the field, this book covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. It focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development, bench-to-bedside translational research, and late-phase clinical development. Numerous examples illustrate the impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation. The author also offers recommendations regarding possible resolutions of the problems.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 611
• Erscheinungstermin: 19. April 2016
• Englisch
• ISBN-13: 9781439849620
• Artikelnr.: 57532909

Autorenporträt

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.

Inhaltsangabe

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.