HANDBOOK OF PHASE II CLINICAL TR

1. Auflage 2017
ISBN: 978-1-4398-2162-6
Verlag: TAYLOR & FRANCIS

Buch, Englisch, 352 Seiten, Format (B × H): 156 mm x 234 mm

Reihe: Chapman & Hall/CRC Biostatistics Series

In the past, pharmaceutical companies have quickly jumped to Phase III without completion and full analysis of Phase II, which consequently led to failure. In the future, more emphasis needs to be placed on quality designed, conducted, and analyzed Phase II clinical trials. Focusing on Phase II clinical trials conducted in a sequential manner, this handbook presents modern techniques of clinical trial design, describes many Phase II designs, and discusses the software used for sample size and power analysis. It also provides sample size tables for those without the appropriate software to calculate sample size and power and includes numerous real-world examples of trial designs in use.

Zielgruppe

Clinicians (statisticians) involved in biomedical research; students in biostatistics, epidemiology, preventive medicine, and other related fields; pharmaceutical companies and government agencies.

Autoren/Hrsg.

SHYR,YU

Berry, Lynne D.

Fachgebiete

• Mathematik | Informatik Mathematik Stochastik Wahrscheinlichkeitsrechnung
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Epidemiologie, Medizinische Statistik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Mathematik | Informatik Mathematik Stochastik Mathematische Statistik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Mathematik & Informatik

Inhaltsverzeichnis

Introduction. Single-stage and multiple-stage designs. Adaptive designs: Bayesian and frequentist. Phase II designs for biomarker-based trials. Phase II trial designs for high-dimensional data. Recommendations. Appendix.

Über Autor(innen)

Yu Shyr is an Ingram Professor of Cancer Research, Professor of Biostatistics, and Director of the Cancer Biostatistics Center at Vanderbilt University School of Medicine.

Lynne D. Berry is an editorial assistant in the Cancer Biostatistics Center at Vanderbilt University School of Medicine.