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Handbook of Phase II Clinical Trial Design

Yu Shyr, Lynne D. Berry (Autoren)

Buch | Hardcover

352 Seiten

2017
Crc Press Inc (Verlag)
978-1-4398-2162-6 (ISBN)

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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.

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.

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.

Erscheint lt. Verlag	26.6.2017
Reihe/Serie	Chapman & Hall/CRC Biostatistics Series
Verlagsort	Bosa Roca
Sprache	englisch
Maße	156 x 234 mm
Themenwelt	Mathematik / Informatik ► Mathematik
	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie
	Technik
ISBN-10	1-4398-2162-3 / 1439821623
ISBN-13	978-1-4398-2162-6 / 9781439821626
Zustand	Neuware