Statistics

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Clinical Trial Optimization Using R

Rajeshwari V Pandharipande, Erik Pulkstenis
May 16, 2017

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...

Clinical Trial Data Analysis Using R and SAS, Second Edition

Ding-Geng (Din) Chen, Karl E. Peace, Pinggao Zhang
May 16, 2017

Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it …The...

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials

John O'Quigley, Alexia Iasonos, Björn Bornkamp
April 26, 2017

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of...

Meta-Analysis in Psychiatry Research: Fundamental and Advanced Methods

Mallikarjun B. Hanji
March 21, 2017

This book introduces the latest meta-analytical methods and discusses their applications in the field of psychiatry. A comprehensive list of methods used in meta-analysis has been described in simple language and demonstrated with real-time examples. This informative volume explains the importance...

Improving Population Health Using Electronic Health Records: Methods for Data Management and Epidemiological Analysis

Neal D. Goldstein
March 02, 2017

Electronic health records (EHRs) have become commonplace in the medical profession. Health data are readily captured and permanently stored in a digital fashion, and consequently, are increasingly being utilized in health research. The quality of this research depends upon the investigator’s...

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials

T James Kodera
February 16, 2017

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The...

Methods in Comparative Effectiveness Research

Constantine Gatsonis, Sally C. Morton
February 07, 2017

Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that...

Biosimilar Clinical Development: Scientific Considerations and New Methodologies

Kerry B. Barker, Sandeep M. Menon, Ralph B. D'Agostino, Sr., Siyan Xu, Bo Jin, PhD
January 17, 2017

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in...

Bioequivalence and Statistics in Clinical Pharmacology, Second Edition

Scott D. Patterson, Byron Jones
December 20, 2016

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and...

Data and Safety Monitoring Committees in Clinical Trials, Second Edition

Jay Herson
December 13, 2016

Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young...

Applied Surrogate Endpoint Evaluation Methods with SAS and R

Ariel Alonso, Theophile Bigirumurame, Tomasz Burzykowski, Marc Buyse, Geert Molenberghs, Leacky Muchene, Nolen Joy Perualila, Ziv Shkedy, Wim Van der Elst
December 08, 2016

An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate...

Analyzing Longitudinal Clinical Trial Data: A Practical Guide

Lowell Skar, Ilya Lipkovich
December 06, 2016

Analyzing Longitudinal Clinical Trial Data: A Practical Guide provide practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice. This book, with its example-oriented approach that includes numerous SAS and R code...

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