Shein-Chung Chow, Mark Chang

Adaptive Design Methods in Clinical Trials (eBook, PDF)

• Format: PDF

Produktbeschreibung

This second edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. This edition significantly updates the chapters on protocol amendment and clinical trial simulation to incorporate the latest changes. It also includes five entirely new chapters on two-stage adaptive design, biomarker adaptive trials, target clinical trials, sample size and power estimation, and regulatory perspectives.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 374
• Erscheinungstermin: 1. Dezember 2011
• Englisch
• ISBN-13: 9781439839881
• Artikelnr.: 38445402

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.