Buch, Englisch, 375 Seiten, Format (B × H): 163 mm x 231 mm, Gewicht: 680 g
Buch, Englisch, 375 Seiten, Format (B × H): 163 mm x 231 mm, Gewicht: 680 g
Reihe: Chapman & Hall/CRC Biostatistics Series
ISBN: 978-1-4398-3987-4
Verlag: CRC Press
New to the Second Edition
Along with revisions throughout the text, 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.
Following in the tradition of its acclaimed predecessor, this second edition continues to offer an up-to-date resource for clinical scientists and researchers in academia, regulatory agencies, and the pharmaceutical industry. Written in an intuitive style at a basic mathematical and statistical level, the book maintains its practical approach with an emphasis on concepts via numerous examples and illustrations.
Zielgruppe
Professional Practice & Development
Autoren/Hrsg.
Fachgebiete
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Mathematik & Informatik
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
Weitere Infos & Material
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 Regulatory Perspectives — A Review of FDA Draft Guidance.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.