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With the exception of two chapters, our first book Clinical Trial Methodology (Peace and Chen (2010)) contained no statistical analysis software code for the analysis results presented therein. In this book we provide a thorough presentation of biostatistical analyses of clinical trial data with detailed step-by-step illustrations on their implementation using R. In each chapter, examples of clinical trials based on the authors’ actual experience in many areas of clinical drug development are presented. After understanding the application, various biostatistical methods appropriate for analyzing data from the clinical trials are identified. Then analysis code is developed using appropriate R packages and functions to analyze the data. Analysis code development and results are presented in a stepwise fashion. This stepwise approach should enable readers to follow the logic and gain an understanding of the analysis methods and the R implementation so that they may use R to analyze their own clinical trial data.

Based on their experience in biostatistical research and working in clinical development, the authors understand that there are gaps between developed statistical methods and applications of statistical methods by students and practitioners. This book is intended to fill this gap by illustrating the implementation of statistical methods using R applied to real clinical trial data following a step-by-step presentation style.

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