Clinical Trial Biostatistics and Biopharmaceutical Applications - Couverture rigide

Couverture rigide

ISBN 10 : 1482212188 ISBN 13 : 9781482212181

Editeur : Chapman & Hall/CRC, 2014

Synopsis

Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry.

Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data.

In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints.

This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.

A propos du livre

À propos de l?auteur

Walter R. Young, Ding-Geng Chen

Détails de l'édition

• Éditeur: Chapman & Hall/CRC
• Date d'édition: 2014
• Langue: anglais
• ISBN 10: 1482212188
• ISBN 13: 9781482212181
• Reliure: Relié
• Numéro d'édition: 1
• Nombre de pages: 580
• Éditeur: Young Walter R., Chen Ding-Geng (Din)
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible