Multiple Testing Problems in Pharmaceutical Statistics

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Publisher : CRC Press
ISBN 13 : 1584889853
Total Pages : 323 pages
Book Rating : 4.5/5 (848 download)

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Book Synopsis Multiple Testing Problems in Pharmaceutical Statistics by : Alex Dmitrienko

Download or read book Multiple Testing Problems in Pharmaceutical Statistics written by Alex Dmitrienko and published by CRC Press. This book was released on 2009-12-08 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple c

Group Sequential Methods with Applications to Clinical Trials

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Publisher : CRC Press
ISBN 13 : 9781584888581
Total Pages : 416 pages
Book Rating : 4.8/5 (885 download)

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Book Synopsis Group Sequential Methods with Applications to Clinical Trials by : Christopher Jennison

Download or read book Group Sequential Methods with Applications to Clinical Trials written by Christopher Jennison and published by CRC Press. This book was released on 1999-09-15 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.

Handbook of Multiple Comparisons

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Publisher : CRC Press
ISBN 13 : 0429633882
Total Pages : 418 pages
Book Rating : 4.4/5 (296 download)

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Book Synopsis Handbook of Multiple Comparisons by : Xinping Cui

Download or read book Handbook of Multiple Comparisons written by Xinping Cui and published by CRC Press. This book was released on 2021-11-18 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by experts that include originators of some key ideas, chapters in the Handbook of Multiple Testing cover multiple comparison problems big and small, with guidance toward error rate control and insights on how principles developed earlier can be applied to current and emerging problems. Some highlights of the coverages are as follows. Error rate control is useful for controlling the incorrect decision rate. Chapter 1 introduces Tukey's original multiple comparison error rates and point to how they have been applied and adapted to modern multiple comparison problems as discussed in the later chapters. Principles endure. While the closed testing principle is more familiar, Chapter 4 shows the partitioning principle can derive confidence sets for multiple tests, which may become important as the profession goes beyond making decisions based on p-values. Multiple comparisons of treatment efficacy often involve multiple doses and endpoints. Chapter 12 on multiple endpoints explains how different choices of endpoint types lead to different multiplicity adjustment strategies, while Chapter 11 on the MCP-Mod approach is particularly useful for dose-finding. To assess efficacy in clinical trials with multiple doses and multiple endpoints, the reader can see the traditional approach in Chapter 2, the Graphical approach in Chapter 5, and the multivariate approach in Chapter 3. Personalized/precision medicine based on targeted therapies, already a reality, naturally leads to analysis of efficacy in subgroups. Chapter 13 draws attention to subtle logical issues in inferences on subgroups and their mixtures, with a principled solution that resolves these issues. This chapter has implication toward meeting the ICHE9R1 Estimands requirement. Besides the mere multiple testing methodology itself, the handbook also covers related topics like the statistical task of model selection in Chapter 7 or the estimation of the proportion of true null hypotheses (or, in other words, the signal prevalence) in Chapter 8. It also contains decision-theoretic considerations regarding the admissibility of multiple tests in Chapter 6. The issue of selected inference is addressed in Chapter 9. Comparison of responses can involve millions of voxels in medical imaging or SNPs in genome-wide association studies (GWAS). Chapter 14 and Chapter 15 provide state of the art methods for large scale simultaneous inference in these settings.

Analysis of Clinical Trials Using SAS

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Publisher : SAS Institute
ISBN 13 : 1635261449
Total Pages : 455 pages
Book Rating : 4.6/5 (352 download)

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Book Synopsis Analysis of Clinical Trials Using SAS by : Alex Dmitrienko

Download or read book Analysis of Clinical Trials Using SAS written by Alex Dmitrienko and published by SAS Institute. This book was released on 2017-07-17 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Encyclopedia of Research Design

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Publisher : SAGE
ISBN 13 : 1412961270
Total Pages : 1779 pages
Book Rating : 4.4/5 (129 download)

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Book Synopsis Encyclopedia of Research Design by : Neil J. Salkind

Download or read book Encyclopedia of Research Design written by Neil J. Salkind and published by SAGE. This book was released on 2010-06-22 with total page 1779 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Comprising more than 500 entries, the Encyclopedia of Research Design explains how to make decisions about research design, undertake research projects in an ethical manner, interpret and draw valid inferences from data, and evaluate experiment design strategies and results. Two additional features carry this encyclopedia far above other works in the field: bibliographic entries devoted to significant articles in the history of research design and reviews of contemporary tools, such as software and statistical procedures, used to analyze results. It covers the spectrum of research design strategies, from material presented in introductory classes to topics necessary in graduate research; it addresses cross- and multidisciplinary research needs, with many examples drawn from the social and behavioral sciences, neurosciences, and biomedical and life sciences; it provides summaries of advantages and disadvantages of often-used strategies; and it uses hundreds of sample tables, figures, and equations based on real-life cases."--Publisher's description.

Mathematical Statistics and Applications

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Publisher : IMS
ISBN 13 : 9780940600577
Total Pages : 532 pages
Book Rating : 4.6/5 (5 download)

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Book Synopsis Mathematical Statistics and Applications by : Marc Moore

Download or read book Mathematical Statistics and Applications written by Marc Moore and published by IMS. This book was released on 2003 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Group Sequential and Confirmatory Adaptive Designs in Clinical Trials

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Author :
Publisher : Springer
ISBN 13 : 3319325620
Total Pages : 310 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Group Sequential and Confirmatory Adaptive Designs in Clinical Trials by : Gernot Wassmer

Download or read book Group Sequential and Confirmatory Adaptive Designs in Clinical Trials written by Gernot Wassmer and published by Springer. This book was released on 2016-07-04 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application. The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.

Handbook of Sequential Analysis

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Publisher : CRC Press
ISBN 13 : 9780824784089
Total Pages : 672 pages
Book Rating : 4.7/5 (84 download)

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Book Synopsis Handbook of Sequential Analysis by : B.K. Ghosh

Download or read book Handbook of Sequential Analysis written by B.K. Ghosh and published by CRC Press. This book was released on 1991-04-24 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sequential analysis refers to the body of statistical theory and methods where the sample size may depend in a random manner on the accumulating data. A formal theory in which optimal tests are derived for simple statistical hypotheses in such a framework was developed by Abraham Wald in the early 1

Statistical Hypothesis Testing in Context: Volume 52

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Publisher : Cambridge University Press
ISBN 13 : 1108530435
Total Pages : 449 pages
Book Rating : 4.1/5 (85 download)

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Book Synopsis Statistical Hypothesis Testing in Context: Volume 52 by : Michael P. Fay

Download or read book Statistical Hypothesis Testing in Context: Volume 52 written by Michael P. Fay and published by Cambridge University Press. This book was released on 2022-05-05 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fay and Brittain present statistical hypothesis testing and compatible confidence intervals, focusing on application and proper interpretation. The emphasis is on equipping applied statisticians with enough tools - and advice on choosing among them - to find reasonable methods for almost any problem and enough theory to tackle new problems by modifying existing methods. After covering the basic mathematical theory and scientific principles, tests and confidence intervals are developed for specific types of data. Essential methods for applications are covered, such as general procedures for creating tests (e.g., likelihood ratio, bootstrap, permutation, testing from models), adjustments for multiple testing, clustering, stratification, causality, censoring, missing data, group sequential tests, and non-inferiority tests. New methods developed by the authors are included throughout, such as melded confidence intervals for comparing two samples and confidence intervals associated with Wilcoxon-Mann-Whitney tests and Kaplan-Meier estimates. Examples, exercises, and the R package asht support practical use.

Randomization in Clinical Trials

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Publisher : John Wiley & Sons
ISBN 13 : 1118742249
Total Pages : 284 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Randomization in Clinical Trials by : William F. Rosenberger

Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition “All medical statisticians involved in clinical trials should read this book...” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.

NBS Special Publication

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Publisher :
ISBN 13 :
Total Pages : 574 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis NBS Special Publication by :

Download or read book NBS Special Publication written by and published by . This book was released on 1970 with total page 574 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Methods and Applications of Statistics in Clinical Trials, Volume 1

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Publisher : John Wiley & Sons
ISBN 13 : 1118595912
Total Pages : 937 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Methods and Applications of Statistics in Clinical Trials, Volume 1 by : Narayanaswamy Balakrishnan

Download or read book Methods and Applications of Statistics in Clinical Trials, Volume 1 written by Narayanaswamy Balakrishnan and published by John Wiley & Sons. This book was released on 2014-03-05 with total page 937 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis. Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials. Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features: Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials Over 100 contributions from leading academics, researchers, and practitioners An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials Group Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology,and public health.

Index Medicus

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Publisher :
ISBN 13 :
Total Pages : 2160 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Index Medicus by :

Download or read book Index Medicus written by and published by . This book was released on 2004 with total page 2160 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vols. for 1963- include as pt. 2 of the Jan. issue: Medical subject headings.

Small Clinical Trials

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Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Statistical Analysis of Failure Time Data

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Publisher : John Wiley & Sons
ISBN 13 : 1118031237
Total Pages : 462 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis The Statistical Analysis of Failure Time Data by : John D. Kalbfleisch

Download or read book The Statistical Analysis of Failure Time Data written by John D. Kalbfleisch and published by John Wiley & Sons. This book was released on 2011-01-25 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains additional discussion and examples on left truncationas well as material on more general censoring and truncationpatterns. Introduces the martingale and counting process formulation swillbe in a new chapter. Develops multivariate failure time data in a separate chapterand extends the material on Markov and semi Markovformulations. Presents new examples and applications of data analysis.

How to Use Sequential Statistical Methods

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Publisher :
ISBN 13 :
Total Pages : 68 pages
Book Rating : 4.3/5 (97 download)

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Book Synopsis How to Use Sequential Statistical Methods by : Thomas P. McWilliams

Download or read book How to Use Sequential Statistical Methods written by Thomas P. McWilliams and published by . This book was released on 1989 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: This primer contains everything you need to know about the construction of sequential sampling plans. Simple examples illustrating sequential procedures help lead you through this guide.Benefits:A great resource for the Certified Quality Engineer's exam! Contents:Sequential Test Plans Curtailed Test Plans Double Sampling Plan Wald's Sequential Plan Truncated Sequential Plan Wald Sequential Test Procedure Applications of Sequential Methods Attributes Sampling Methods Variables Sampling Direct Method of Calculating OC and ASN Functions Sequential Estimation

Survival Analysis

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Publisher : Springer Science & Business Media
ISBN 13 : 1475727283
Total Pages : 508 pages
Book Rating : 4.4/5 (757 download)

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Book Synopsis Survival Analysis by : John P. Klein

Download or read book Survival Analysis written by John P. Klein and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: Making complex methods more accessible to applied researchers without an advanced mathematical background, the authors present the essence of new techniques available, as well as classical techniques, and apply them to data. Practical suggestions for implementing the various methods are set off in a series of practical notes at the end of each section, while technical details of the derivation of the techniques are sketched in the technical notes. This book will thus be useful for investigators who need to analyse censored or truncated life time data, and as a textbook for a graduate course in survival analysis, the only prerequisite being a standard course in statistical methodology.