Clinical Trial Optimization Using R

Alex Dmitrienko, Erik Pulkstenis (Herausgeber)

Buch | Hardcover

338 Seiten

2017
Chapman & Hall/CRC (Verlag)
978-1-4987-3507-0 (ISBN)

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Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making.

This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.

Alex Dmitrienko is President at Mediana Inc. He has been actively involved in biostatistical research with emphasis on multiplicity issues in clinical trials, subgroup analysis, innovative trial designs and clinical trial optimization. He has published over 90 papers and authored/edited three books. Dr. Dmitrienko is a Fellow of the American Statistical Association. Erik Pulkstenis is Vice President, Clinical Biostatistics and Data Management at MedImmune, and has worked in the medical device and biopharmaceutical industry for over 20 years. In addition, he served as a faculty member for the Institute for Professional Education teaching on categorical data analysis. His research interests include evidence-based decision making, precision medicine, and applications of statistical methods in oncology.

Introduction to Clinical Scenario Evaluation. Clinical Scenario Evaluation and Clinical Trial Optimization. General Clinical Trials Settings. Clinical Trials with Multiple Objectives. Clinical Trials with Adaptive Designs. Subgroup Analysis in Clinical Trials. Dose-Finding Clinical Trials. Bayesian Approaches in Clinical Trials

Erscheinungsdatum	26.06.2017
Reihe/Serie	Chapman & Hall/CRC Biostatistics Series
Zusatzinfo	100 Illustrations, black and white
Sprache	englisch
Maße	156 x 234 mm
Gewicht	1300 g
Themenwelt	Mathematik / Informatik ► Mathematik
	Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie
	Naturwissenschaften ► Biologie
	Technik
ISBN-10	1-4987-3507-X / 149873507X
ISBN-13	978-1-4987-3507-0 / 9781498735070
Zustand	Neuware