analysis of clinical trials using sas a practical guide

Download Book Analysis Of Clinical Trials Using Sas A Practical Guide in PDF format. You can Read Online Analysis Of Clinical Trials Using Sas A Practical Guide here in PDF, EPUB, Mobi or Docx formats.

Analysis Of Clinical Trials Using Sas

Author : Alex Dmitrienko
ISBN : 9781635261448
Genre : Computers
File Size : 50. 69 MB
Format : PDF, Docs
Download : 675
Read : 519

Get This Book


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.

Pharmaceutical Statistics Using Sas

Author : Alex Dmitrienko
ISBN : 9781599943572
Genre : Computers
File Size : 32. 98 MB
Format : PDF, ePub
Download : 837
Read : 1010

Get This Book


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.

Clinical Trial Data Analysis Using R And Sas

Author : Ding-Geng (Din) Chen
ISBN : 9781351651141
Genre : Mathematics
File Size : 80. 81 MB
Format : PDF, Kindle
Download : 364
Read : 691

Get This Book


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.

Modern Approaches To Clinical Trials Using Sas Classical Adaptive And Bayesian Methods

Author : Sandeep Menon
ISBN : 9781629600826
Genre : Mathematics
File Size : 80. 18 MB
Format : PDF, Mobi
Download : 902
Read : 577

Get This Book


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.

Common Statistical Methods For Clinical Research With Sas Examples

Author : Glenn A. Walker
ISBN : 9781607644255
Genre : Computers
File Size : 23. 98 MB
Format : PDF
Download : 841
Read : 1265

Get This Book


Thoroughly updated edition of the popular introductory statistics book for clinical researchers. This new edition has been extensively updated to include the use of ODS graphics in numerous examples as well as a new emphasis on PROC MIXED.

Analyzing Longitudinal Clinical Trial Data

Author : Craig Mallinckrodt
ISBN : 9781351737692
Genre : Mathematics
File Size : 46. 26 MB
Format : PDF, Mobi
Download : 278
Read : 1319

Get This Book


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 fragments, is an essential resource for statisticians and graduate students specializing in medical research. The authors provide clear descriptions of the relevant statistical theory and illustrate practical considerations for modeling longitudinal data. Topics covered include choice of endpoint and statistical test; modeling means and the correlations between repeated measurements; accounting for covariates; modeling categorical data; model verification; methods for incomplete (missing) data that includes the latest developments in sensitivity analyses, along with approaches for and issues in choosing estimands; and means for preventing missing data. Each chapter stands alone in its coverage of a topic. The concluding chapters provide detailed advice on how to integrate these independent topics into an over-arching study development process and statistical analysis plan.

Risk Based Monitoring And Fraud Detection In Clinical Trials Using Jmp And Sas

Author : Richard C. Zink
ISBN : 9781629592329
Genre : Computers
File Size : 82. 2 MB
Format : PDF, ePub, Mobi
Download : 594
Read : 322

Get This Book


International guidelines recommend that clinical trial data should be actively reviewed or monitored; the well-being of trial participants and the validity and integrity of the final analysis results are at stake. Risk-based monitoring (RBM) makes use of central computerized review of clinical trial data and site metrics to determine if and when clinical sites should receive more extensive quality review or intervention. Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS describes analyses for RBM that incorporate and extend the recommendations of TransCelerate Biopharm Inc., methods to detect potential patient-or investigator misconduct, snapshot comparisons to more easily identify new or modified data, and other novel visual and analytical techniques to enhance safety and quality reviews. The analytical methods described enable the clinical trial team to take a proactive approach to data quality and safety to streamline clinical development activities and address shortcomings while the study is ongoing.

Design Analysis Of Clinical Trials For Economic Evaluation Reimbursement

Author : Iftekhar Khan
ISBN : 9781466505483
Genre : Mathematics
File Size : 47. 1 MB
Format : PDF, Mobi
Download : 607
Read : 182

Get This Book


Economic evaluation has become an essential component of clinical trial design to show that new treatments and technologies offer value to payers in various healthcare systems. Although many books exist that address the theoretical or practical aspects of cost-effectiveness analysis, this book differentiates itself from the competition by detailing how to apply health economic evaluation techniques in a clinical trial context, from both academic and pharmaceutical/commercial perspectives. It also includes a special chapter for clinical trials in Cancer. Design & Analysis of Clinical Trials for Economic Evaluation & Reimbursement is not just about performing cost-effectiveness analyses. It also emphasizes the strategic importance of economic evaluation and offers guidance and advice on the complex factors at play before, during, and after an economic evaluation. Filled with detailed examples, the book bridges the gap between applications of economic evaluation in industry (mainly pharmaceutical) and what students may learn in university courses. It provides readers with access to SAS and STATA code. In addition, Windows-based software for sample size and value of information analysis is available free of charge—making it a valuable resource for students considering a career in this field or for those who simply wish to know more about applying economic evaluation techniques. The book includes coverage of trial design, case report form design, quality of life measures, sample sizes, submissions to regulatory authorities for reimbursement, Markov models, cohort models, and decision trees. Examples and case studies are provided at the end of each chapter. Presenting first-hand insights into how economic evaluations are performed from a drug development perspective, the book supplies readers with the foundation required to succeed in an environment where clinical trials and cost-effectiveness of new treatments are central. It also includes thought-provoking exercises for use in classroom and seminar discussions.

Sas Survival Analysis Techniques For Medical Research

Author : Alan Cantor
ISBN : 1590476239
Genre : Computers
File Size : 83. 92 MB
Format : PDF, Mobi
Download : 888
Read : 990

Get This Book


In this follow-up to "Extending SAS Survival Analysis Techniques for Medical Research," the theory and methods of survival analysis and SAS procedures used to implement the methods are fully described. The new features, along with several useful macros and numerous examples, make this edition a suitable textbook for a course in survival analysis for biostatistics majors and majors in related fields.

Missing Data In Clinical Studies

Author : Geert Molenberghs
ISBN : 0470510439
Genre : Medical
File Size : 78. 63 MB
Format : PDF, Docs
Download : 140
Read : 786

Get This Book


Missing Data in Clinical Studies provides a comprehensive account of the problems arising when data from clinical and related studies are incomplete, and presents the reader with approaches to effectively address them. The text provides a critique of conventional and simple methods before moving on to discuss more advanced approaches. The authors focus on practical and modeling concepts, providing an extensive set of case studies to illustrate the problems described. Provides a practical guide to the analysis of clinical trials and related studies with missing data. Examines the problems caused by missing data, enabling a complete understanding of how to overcome them. Presents conventional, simple methods to tackle these problems, before addressing more advanced approaches, including sensitivity analysis, and the MAR missingness mechanism. Illustrated throughout with real-life case studies and worked examples from clinical trials. Details the use and implementation of the necessary statistical software, primarily SAS. Missing Data in Clinical Studies has been developed through a series of courses and lectures. Its practical approach will appeal to applied statisticians and biomedical researchers, in particular those in the biopharmaceutical industry, medical and public health organisations. Graduate students of biostatistics will also find much of benefit.

Top Download:

Best Books