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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 example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."—Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.
This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration.
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 example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."—Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.
Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.
This book guides researchers in performing and presenting high-quality analyses of all kinds of non-randomized studies, including analyses of observational studies, claims database analyses, assessment of registry data, survey data, pharmaco-economic data, and many more applications. The text is sufficiently detailed to provide not only general guidance, but to help the researcher through all of the standard issues that arise in such analyses. Just enough theory is included to allow the reader to understand the pros and cons of alternative approaches and when to use each method. The numerous contributors to this book illustrate, via real-world numerical examples and SAS code, appropriate implementations of alternative methods. The end result is that researchers will learn how to present high-quality and transparent analyses that will lead to fair and objective decisions from observational data. This book is part of the SAS Press program.
More and more frequently, clinical trials include the evaluation of Health-Related Quality of Life (HRQoL), yet many investigators remain unaware of the unique measurement and analysis issues associated with the assessment of HRQoL. At the end of a study, clinicians and statisticians often face challenging and sometimes insurmountable analytic problems. Design and Analysis of Quality of Life Studies in Clinical Trials details these issues and presents a range of solutions. Written from the author's extensive experience in the field, it focuses on the very specific features of QoL data: its longitudinal nature, multidimensionality, and the problem of missing data. The author uses three real clinical trials throughout her discussions to illustrate practical implementation of the strategies and analytic methods presented. As Quality of Life becomes an increasingly important aspect of clinical trials, it becomes essential for clinicians, statisticians, and designers of these studies to understand and meet the challenges this kind of data present. In this book, SAS and S-PLUS programs, checklists, numerous figures, and a clear, concise presentation combine to provide readers with the tools and skills they need to successfully design, conduct, analyze, and report their own studies.
Clinical Data Quality Checks for CDISC Compliance using SAS is the first book focused on identifying and correcting data quality and CDISC compliance issues with real-world innovative SAS programming techniques such as Proc SQL, metadata and macro programming. Learn to master Proc SQL’s subqueries and summary functions for multi-tasking process. Drawing on his more than 25 years’ experience in the pharmaceutical industry, the author provides a unique approach that empowers SAS programmers to take control of data quality and CDISC compliance. This book helps you create a system of SDTM and ADaM checks that can be tracked for continuous improvement. How often have you encountered issues such as missing required variables, duplicate records, invalid derived variables and invalid sequence of two dates? With the SAS programming techniques introduced in this book, you can start to monitor these and more complex data and CDISC compliance issues. With increased standardization in SDTM and ADaM specifications and data values, codelist dictionaries can be created for better organization, planning and maintenance. This book includes a SAS program to create excel files containing unique values from all SDTM and ADaM variables as columns. In addition, another SAS program compares SDTM and ADaM codelist dictionaries with codelists from define.xml specifications. Having tools to automate this process greatly saves time from doing it manually. Features SDTMs and ADaMs Vitals SDTMs and ADaMs Data CDISC Specifications Compliance CDISC Data Compliance Protocol Compliance Codelist Dictionary Compliance
SAS Programming for R Users, based on the free SAS Education course of the same name, is designed for experienced R users who want to transfer their programming skills to SAS. Emphasis is on programming and not statistical theory or interpretation. You will learn how to write programs in SAS that replicate familiar functions and capabilities in R. This book covers a wide range of topics including the basics of the SAS programming language, how to import data, how to create new variables, random number generation, linear modeling, Interactive Matrix Language (IML), and many other SAS procedures. This book also explains how to write R code directly in the SAS code editor for seamless integration between the two tools. Exercises are provided at the end of each chapter so that you can test your knowledge and practice your programming skills.
Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.
Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.