Clinical Trial Data Analysis Using R

Author : Ding-Geng (Din) Chen,Karl E. Peace
Publisher : CRC Press
Page : 384 pages
File Size : 40,5 Mb
Release : 2010-12-14
Category : Mathematics
ISBN : 9781439840214

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Clinical Trial Data Analysis Using R by Ding-Geng (Din) Chen,Karl E. Peace Pdf

Too often in biostatistical research and clinical trials, a knowledge gap exists between developed statistical methods and the applications of these methods. Filling this gap, Clinical Trial Data Analysis Using R provides a thorough presentation of biostatistical analyses of clinical trial data and shows step by step how to implement the statistical methods using R. The book’s practical, detailed approach draws on the authors’ 30 years of real-world experience in biostatistical research and clinical development. Each chapter presents examples of clinical trials based on the authors’ actual experiences in clinical drug development. Various biostatistical methods for analyzing the data are then identified. The authors develop analysis code step by step using appropriate R packages and functions. This approach enables readers to gain an understanding of the analysis methods and R implementation so that they can use R to analyze their own clinical trial data. With step-by-step illustrations of R implementations, this book shows how to easily use R to simulate and analyze data from a clinical trial. It describes numerous up-to-date statistical methods and offers sound guidance on the processes involved in clinical trials.

Author : Ding-Geng (Din) Chen,Karl E. Peace,Pinggao Zhang
Publisher : CRC Press
Page : 310 pages
File Size : 51,7 Mb
Release : 2017-06-01
Category : Mathematics
ISBN : 9781351651141

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Clinical Trial Data Analysis Using R and SAS by Ding-Geng (Din) Chen,Karl E. Peace,Pinggao Zhang Pdf

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.

Author : Alex Dmitrienko,Erik Pulkstenis
Publisher : CRC Press
Page : 319 pages
File Size : 40,6 Mb
Release : 2019-03-22
Category : Electronic
ISBN : 0367261251

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Clinical Trial Optimization Using R by Alex Dmitrienko,Erik Pulkstenis Pdf

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 supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making. This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.

Author : Nusrat Rabbee
Publisher : CRC Press
Page : 229 pages
File Size : 48,5 Mb
Release : 2020-03-11
Category : Mathematics
ISBN : 9780429766800

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Biomarker Analysis in Clinical Trials with R by Nusrat Rabbee Pdf

The world is awash in data. This volume of data will continue to increase. In the pharmaceutical industry, much of this data explosion has happened around biomarker data. Great statisticians are needed to derive understanding from these data. This book will guide you as you begin the journey into communicating, understanding and synthesizing biomarker data. -From the Foreword, Jared Christensen, Vice President, Biostatistics Early Clinical Development, Pfizer, Inc. Biomarker Analysis in Clinical Trials with R offers practical guidance to statisticians in the pharmaceutical industry on how to incorporate biomarker data analysis in clinical trial studies. The book discusses the appropriate statistical methods for evaluating pharmacodynamic, predictive and surrogate biomarkers for delivering increased value in the drug development process. The topic of combining multiple biomarkers to predict drug response using machine learning is covered. Featuring copious reproducible code and examples in R, the book helps students, researchers and biostatisticians get started in tackling the hard problems of designing and analyzing trials with biomarkers. Features: Analysis of pharmacodynamic biomarkers for lending evidence target modulation. Design and analysis of trials with a predictive biomarker. Framework for analyzing surrogate biomarkers. Methods for combining multiple biomarkers to predict treatment response. Offers a biomarker statistical analysis plan. R code, data and models are given for each part: including regression models for survival and longitudinal data, as well as statistical learning models, such as graphical models and penalized regression models.

Author : Mathias Harrer,Pim Cuijpers,Toshi A. Furukawa,David D. Ebert
Publisher : CRC Press
Page : 500 pages
File Size : 54,7 Mb
Release : 2021-09-15
Category : Mathematics
ISBN : 9781000435634

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Doing Meta-Analysis with R by Mathias Harrer,Pim Cuijpers,Toshi A. Furukawa,David D. Ebert Pdf

Doing Meta-Analysis with R: A Hands-On Guide serves as an accessible introduction on how meta-analyses can be conducted in R. Essential steps for meta-analysis are covered, including calculation and pooling of outcome measures, forest plots, heterogeneity diagnostics, subgroup analyses, meta-regression, methods to control for publication bias, risk of bias assessments and plotting tools. Advanced but highly relevant topics such as network meta-analysis, multi-three-level meta-analyses, Bayesian meta-analysis approaches and SEM meta-analysis are also covered. A companion R package, dmetar, is introduced at the beginning of the guide. It contains data sets and several helper functions for the meta and metafor package used in the guide. The programming and statistical background covered in the book are kept at a non-expert level, making the book widely accessible. Features • Contains two introductory chapters on how to set up an R environment and do basic imports/manipulations of meta-analysis data, including exercises • Describes statistical concepts clearly and concisely before applying them in R • Includes step-by-step guidance through the coding required to perform meta-analyses, and a companion R package for the book

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 47,5 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

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The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Page : 304 pages
File Size : 44,6 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9780309316323

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Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Author : Nicholas J. Horton,Ken Kleinman
Publisher : CRC Press
Page : 313 pages
File Size : 51,8 Mb
Release : 2015-03-10
Category : Mathematics
ISBN : 9781482237375

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Using R and RStudio for Data Management, Statistical Analysis, and Graphics by Nicholas J. Horton,Ken Kleinman Pdf

Improve Your Analytical SkillsIncorporating the latest R packages as well as new case studies and applications, Using R and RStudio for Data Management, Statistical Analysis, and Graphics, Second Edition covers the aspects of R most often used by statistical analysts. New users of R will find the book's simple approach easy to understand while more

Author : Ding-Geng Chen,Karl E. Peace
Publisher : Unknown
Page : 363 pages
File Size : 51,8 Mb
Release : 2011
Category : Clinical trials
ISBN : 0429151322

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Clinical Trial Data Analysis Using R by Ding-Geng Chen,Karl E. Peace Pdf

"With examples based on the authors' 30 years of real-world experience in many areas of clinical drug development, this book provides a thorough presentation of clinical trial methodology. It presents detailed step-by-step illustrations on the implementation of the open-source software R. Case studies demonstrate how to select the appropriate clinical trial data. The authors introduce the corresponding biostatistical analysis methods, followed by the step-by-step data analysis using R. They also offer the R program for download, along with other essential data, on their website"--Provided by publisher.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Publisher : National Academies Press
Page : 222 pages
File Size : 41,8 Mb
Release : 2001-01-01
Category : Medical
ISBN : 0309171148

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Small Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Pdf

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Author : Ding-Geng Chen,Karl E. Peace,Pinggao Zhang
Publisher : Unknown
Page : 411 pages
File Size : 54,5 Mb
Release : 2017
Category : Clinical trials
ISBN : 1351641646

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Clinical Trial Data Analysis Using R and SAS, Second Edition by Ding-Geng Chen,Karl E. Peace,Pinggao Zhang Pdf

Author : Alex Dmitrienko,Erik Pulkstenis
Publisher : CRC Press
Page : 319 pages
File Size : 41,7 Mb
Release : 2017-08-10
Category : Mathematics
ISBN : 9781498735087

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Clinical Trial Optimization Using R by Alex Dmitrienko,Erik Pulkstenis Pdf

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 supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making. This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.

Author : Weichung Joe Shih,Joseph Aisner
Publisher : CRC Press
Page : 320 pages
File Size : 52,6 Mb
Release : 2021-10-26
Category : Medical
ISBN : 9781000462814

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Statistical Design, Monitoring, and Analysis of Clinical Trials by Weichung Joe Shih,Joseph Aisner Pdf

Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Author : Alex Dmitrienko,Gary G. Koch
Publisher : SAS Institute
Page : 455 pages
File Size : 49,8 Mb
Release : 2017-07-17
Category : Computers
ISBN : 9781635261448

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Analysis of Clinical Trials Using SAS by Alex Dmitrienko,Gary G. Koch Pdf

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.

Author : James Ramsay,Giles Hooker,Spencer Graves
Publisher : Springer Science & Business Media
Page : 213 pages
File Size : 51,5 Mb
Release : 2009-06-29
Category : Computers
ISBN : 9780387981857

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Functional Data Analysis with R and MATLAB by James Ramsay,Giles Hooker,Spencer Graves Pdf

The book provides an application-oriented overview of functional analysis, with extended and accessible presentations of key concepts such as spline basis functions, data smoothing, curve registration, functional linear models and dynamic systems Functional data analysis is put to work in a wide a range of applications, so that new problems are likely to find close analogues in this book The code in R and Matlab in the book has been designed to permit easy modification to adapt to new data structures and research problems