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The book Clinical Trial Optimization Using R by A. Dmitrienko and E. Pulkstenis gives a comprehensible introduction to the subject of Clinical Scenario Evaluation (CSE) and subsequent optimization . . . The authors present an approach that is easy to understand and to implement in R. The book is well structured, and the underlying principles are described in detail and illustrated by several case studies. ~ Kiana Kreitz, Institute of Biostatistics and Clinical Research, Germany

"""The book Clinical Trial Optimization Using R by A. Dmitrienko and E. Pulkstenis gives a comprehensible introduction to the subject of Clinical Scenario Evaluation (CSE) and subsequent optimization . . . The authors present an approach that is easy to understand and to implement in R. The book is well structured, and the underlying principles are described in detail and illustrated by several case studies."" ~ Kiana Kreitz, Institute of Biostatistics and Clinical Research, Germany"

Author Information

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.

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