Shein-Chung Chow, Mark Chang

Adaptive Design Methods in Clinical Trials

• Gebundenes Buch

Produktbeschreibung

This acclaimed book covers the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures based on accrued data of ongoing clinical trials. It presents a well-balanced summary of current regulatory perspectives, recently developed statistical methods, and statistical tests for seamless phase II/III adaptive designs. This edition features two new chapters as well as a complete rewrite of the chapter on computer simulation. It also includes computer simulations and various case studies to ensure a practical understanding of the methodologies.

Produktdetails

• Verlag: CRC Press
• 2nd edition
• Seitenzahl: 375
• Erscheinungstermin: 1. Dezember 2011
• Englisch
• Abmessung: 231mm x 163mm x 28mm
• Gewicht: 680g
• ISBN-13: 9781439839874
• ISBN-10: 1439839875
• Artikelnr.: 33805762

Autorenporträt

Shein-Chung Chow 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 numerous papers and books, including the Handbook of Adaptive Designs in Pharmaceutical and Clinical Development and Controversial Statistical Issues in Clinical Trials. Mark Chang is the executive director of biostatistics and data management at AMAG Pharmaceuticals and an adjunct professor at Boston University. A fellow of the American Statistical Association, Dr. Chang is a co-founder of the International Society for Biopharmaceutical Statistics and serves on the editorial boards of two statistical journals. He has authored many publications, including Adaptive Design Theory and Implementation Using SAS and R and Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies.

Inhaltsangabe

Introduction. Protocol Amendment. Adaptive Randomization. Adaptive
Hypotheses. Adaptive Dose-Escalation Trials. Adaptive Group Sequential
Design. Statistical Tests for Seamless Adaptive Designs. Adaptive Sample
Size Adjustment. Two-Stage Adaptive Design. Adaptive Treatment Switching.
Bayesian Approach. Biomarker Adaptive Trials. Target Clinical Trials.
Sample Size and Power Estimation. Clinical Trial Simulation. Regulatory
Perspectives - A Review of FDA Draft Guidance. Case Studies. Bibliography.
Subject Index.