Statistical Thinking In Clinical Trials

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Statistical Thinking in Clinical Trials

Michael A. Proschan
Statistical Thinking in Clinical Trials Book PDF

Author : Michael A. Proschan
Publisher : CRC Press
Page : 270 pages
File Size : 42,7 Mb
Release : 2021-11-24
Category : Mathematics
ISBN : 9781351673112

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Statistical Thinking in Clinical Trials by Michael A. Proschan Pdf

Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and randomization-based inference is the cornerstone of this book. Read this book to learn the elegance and simplicity of re-randomization tests as the basis for statistical inference (the analyze as you randomize principle) and see how re-randomization tests can save a trial that required an unplanned, mid-course design change. Other principles enable the reader to quickly and confidently check calculations without relying on computer programs. The `EZ’ principle says that a single sample size formula can be applied to a multitude of statistical tests. The `O minus E except after V’ principle provides a simple estimator of the log odds ratio that is ideally suited for stratified analysis with a binary outcome. The same principle can be used to estimate the log hazard ratio and facilitate stratified analysis in a survival setting. Learn these and other simple techniques that will make you an invaluable clinical trial statistician.

Statistical Thinking in Clinical Trials

Michael A. Proschan
Statistical Thinking in Clinical Trials Book PDF

Author : Michael A. Proschan
Publisher : CRC Press
Page : 276 pages
File Size : 40,6 Mb
Release : 2021-11-24
Category : Mathematics
ISBN : 9781351673105

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Statistical Thinking in Clinical Trials by Michael A. Proschan Pdf

Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and randomization-based inference is the cornerstone of this book. Read this book to learn the elegance and simplicity of re-randomization tests as the basis for statistical inference (the analyze as you randomize principle) and see how re-randomization tests can save a trial that required an unplanned, mid-course design change. Other principles enable the reader to quickly and confidently check calculations without relying on computer programs. The `EZ’ principle says that a single sample size formula can be applied to a multitude of statistical tests. The `O minus E except after V’ principle provides a simple estimator of the log odds ratio that is ideally suited for stratified analysis with a binary outcome. The same principle can be used to estimate the log hazard ratio and facilitate stratified analysis in a survival setting. Learn these and other simple techniques that will make you an invaluable clinical trial statistician.

Strategy and Statistics in Clinical Trials

Joseph Tal
Strategy and Statistics in Clinical Trials Book PDF

Author : Joseph Tal
Publisher : Academic Press
Page : 278 pages
File Size : 54,6 Mb
Release : 2011-06-26
Category : Medical
ISBN : 9780123869920

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Strategy and Statistics in Clinical Trials by Joseph Tal Pdf

Strategy and Statistics in Clinical Trials deals with the research processes and the role of statistics in these processes. The book offers real-life case studies and provides a practical, how to guide to biomedical R&D. It describes the statistical building blocks and concepts of clinical trials and promotes effective cooperation between statisticians and important other parties. The discussion is organized around 15 chapters. After providing an overview of clinical development and statistics, the book explores questions when planning clinical trials, along with the attributes of medical products. It then explains how to set research objectives and goes on to consider statistical thinking, estimation, testing procedures, and statistical significance, explanation and prediction. The rest of the book focuses on exploratory and confirmatory clinical trials; hypothesis testing and multiplicity; elements of clinical trial design; choosing trial endpoints; and determination of sample size. This book is for all individuals engaged in clinical research who are interested in a better understanding of statistics, including professional clinical researchers, professors, physicians, and researchers in laboratory. It will also be of interest to corporate and government laboratories, clinical research nurses, members of the allied health professions, and post-doctoral and graduate students. Enables non-statisticians to better understand research processes and statistics' role in these processes Offers real-life case studies and provides a practical, "how to" guide to biomedical R&D Delineates the statistical building blocks and concepts of clinical trials Promotes effective cooperation between statisticians and important other parties

Statistical Thinking for Non-Statisticians in Drug Regulation

Richard Kay
Statistical Thinking for Non Statisticians in Drug Regulation Book PDF

Author : Richard Kay
Publisher : John Wiley & Sons
Page : 436 pages
File Size : 45,9 Mb
Release : 2022-11-29
Category : Medical
ISBN : 9781119867401

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Statistical Thinking for Non-Statisticians in Drug Regulation by Richard Kay Pdf

STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.

Statistical Thinking in Epidemiology

Yu-Kang Tu,Mark Gilthorpe
Statistical Thinking in Epidemiology Book PDF

Author : Yu-Kang Tu,Mark Gilthorpe
Publisher : CRC Press
Page : 231 pages
File Size : 52,7 Mb
Release : 2016-04-19
Category : Mathematics
ISBN : 9781420099928

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Statistical Thinking in Epidemiology by Yu-Kang Tu,Mark Gilthorpe Pdf

While biomedical researchers may be able to follow instructions in the manuals accompanying the statistical software packages, they do not always have sufficient knowledge to choose the appropriate statistical methods and correctly interpret their results. Statistical Thinking in Epidemiology examines common methodological and statistical problems

Critical Thinking in Clinical Research

Felipe Fregni,Ben M. W. Illigens
Critical Thinking in Clinical Research Book PDF

Author : Felipe Fregni,Ben M. W. Illigens
Publisher : Oxford University Press
Page : 537 pages
File Size : 47,5 Mb
Release : 2018
Category : Medical
ISBN : 9780199324491

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Critical Thinking in Clinical Research by Felipe Fregni,Ben M. W. Illigens Pdf

Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.

Introduction to Statistical Methods for Clinical Trials

Thomas D. Cook,David L DeMets
Introduction to Statistical Methods for Clinical Trials Book PDF

Author : Thomas D. Cook,David L DeMets
Publisher : CRC Press
Page : 465 pages
File Size : 44,6 Mb
Release : 2007-11-19
Category : Mathematics
ISBN : 9781584880271

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Introduction to Statistical Methods for Clinical Trials by Thomas D. Cook,David L DeMets Pdf

Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.

The R Primer

Claus Thorn Ekstrøm
The R Primer Book PDF

Author : Claus Thorn Ekstrøm
Publisher : Unknown
Page : 0 pages
File Size : 51,8 Mb
Release : 2016
Category : Mathematics
ISBN : 1138058564

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The R Primer by Claus Thorn Ekstrøm Pdf

Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and randomization-based inference is the cornerstone of this book. Read this book to learn the elegance and simplicity of re-randomization tests as the basis for statistical inference (the analyze as you randomize principle) and see how re-randomization tests can save a trial that required an unplanned, mid-course design change. Other principles enable the reader to quickly and confidently check calculations without relying on computer programs. The EZ' principle says that a single sample size formula can be applied to a multitude of statistical tests. The O minus E except after V' principle provides a simple estimator of the log odds ratio that is ideally suited for stratified analysis with a binary outcome. The same principle can be used to estimate the log hazard ratio and facilitate stratified analysis in a survival setting. Learn these and other simple techniques that will make you an invaluable clinical trial statistician.

Regression Modeling Strategies

Frank E. Harrell
Regression Modeling Strategies Book PDF

Author : Frank E. Harrell
Publisher : Springer Science & Business Media
Page : 583 pages
File Size : 42,9 Mb
Release : 2013-03-09
Category : Mathematics
ISBN : 9781475734621

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Regression Modeling Strategies by Frank E. Harrell Pdf

Many texts are excellent sources of knowledge about individual statistical tools, but the art of data analysis is about choosing and using multiple tools. Instead of presenting isolated techniques, this text emphasizes problem solving strategies that address the many issues arising when developing multivariable models using real data and not standard textbook examples. It includes imputation methods for dealing with missing data effectively, methods for dealing with nonlinear relationships and for making the estimation of transformations a formal part of the modeling process, methods for dealing with "too many variables to analyze and not enough observations," and powerful model validation techniques based on the bootstrap. This text realistically deals with model uncertainty and its effects on inference to achieve "safe data mining".

Clinical Trial Methodology

Karl E. Peace,Ding-Geng (Din) Chen
Clinical Trial Methodology Book PDF

Author : Karl E. Peace,Ding-Geng (Din) Chen
Publisher : CRC Press
Page : 420 pages
File Size : 49,7 Mb
Release : 2010-07-20
Category : Mathematics
ISBN : 1584889187

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Clinical Trial Methodology by Karl E. Peace,Ding-Geng (Din) Chen Pdf

Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors’ courses on the subject as well as the first author’s more than 30 years working in the pharmaceutical industry, Clinical Trial Methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research. From ethical issues and sample size considerations to adaptive design procedures and statistical analysis, the book first covers the methodology that spans every clinical trial regardless of the area of application. Crucial to the generic drug industry, bioequivalence clinical trials are then discussed. The authors describe a parallel bioequivalence clinical trial of six formulations incorporating group sequential procedures that permit sample size re-estimation. The final chapters incorporate real-world case studies of clinical trials from the authors’ own experiences. These examples include a landmark Phase III clinical trial involving the treatment of duodenal ulcers and Phase III clinical trials that contributed to the first drug approved for the treatment of Alzheimer’s disease. Aided by the U.S. FDA, the U.S. National Institutes of Health, the pharmaceutical industry, and academia, the area of clinical trial methodology has evolved over the last six decades into a scientific discipline. This guide explores the processes essential for developing and conducting a quality clinical trial protocol and providing quality data collection, biostatistical analyses, and a clinical study report, all while maintaining the highest standards of ethics and excellence.

Understanding Clinical Data Analysis

Ton J. Cleophas,Aeilko H. Zwinderman
Understanding Clinical Data Analysis Book PDF

Author : Ton J. Cleophas,Aeilko H. Zwinderman
Publisher : Springer
Page : 234 pages
File Size : 43,7 Mb
Release : 2016-08-23
Category : Medical
ISBN : 9783319395869

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Understanding Clinical Data Analysis by Ton J. Cleophas,Aeilko H. Zwinderman Pdf

This textbook consists of ten chapters, and is a must-read to all medical and health professionals, who already have basic knowledge of how to analyze their clinical data, but still, wonder, after having done so, why procedures were performed the way they were. The book is also a must-read to those who tend to submerge in the flood of novel statistical methodologies, as communicated in current clinical reports, and scientific meetings. In the past few years, the HOW-SO of current statistical tests has been made much more simple than it was in the past, thanks to the abundance of statistical software programs of an excellent quality. However, the WHY-SO may have been somewhat under-emphasized. For example, why do statistical tests constantly use unfamiliar terms, like probability distributions, hypothesis testing, randomness, normality, scientific rigor, and why are Gaussian curves so hard, and do they make non-mathematicians getting lost all the time? The book will cover the WHY-SOs.

Critical Thinking in Clinical Research

Felipe Fregni,Ben M.W. Illigens
Critical Thinking in Clinical Research Book PDF

Author : Felipe Fregni,Ben M.W. Illigens
Publisher : Oxford University Press
Page : 480 pages
File Size : 43,5 Mb
Release : 2018-03-13
Category : Medical
ISBN : 9780199324507

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Critical Thinking in Clinical Research by Felipe Fregni,Ben M.W. Illigens Pdf

One of the most crucial skills a clinician, scientist, or student can learn is to create, conduct, and interpret the conclusions of a clinical study. Critical Thinking in Clinical Research teaches these fundamentals in four distinct sections, called "units": the first unit focuses on issues surrounding the design of a study such as population, question selection, randomization, and blinding; Unit 2 presents statistical methods such as analyzing data collected, how to present and discuss the data concisely; the third unit covers practical aspects such as methodology, organizational considerations, principles of trial conduct and reporting; and the final unit delves into study designs, providing the advantages and drawbacks of each design style. Each chapter begins with a short introduction, followed by a hypothetical case that challenges the reader to make decisions, to consider pros and cons of specific approaches, and to evaluate options based on specific conditions. Knowing how to critically read and understand scientific papers and to collect, analyze, and interpret research data, which they in turn can then present in their own scientific manuscript makes this book the perfect resource for anyone looking to contribute to the wealth of scientific and medical inquiry.

Statistical Monitoring of Clinical Trials

Michael A. Proschan,K. K. Gordon Lan,Janet Turk Wittes
Statistical Monitoring of Clinical Trials Book PDF

Author : Michael A. Proschan,K. K. Gordon Lan,Janet Turk Wittes
Publisher : Springer Science & Business Media
Page : 268 pages
File Size : 53,7 Mb
Release : 2006-12-31
Category : Medical
ISBN : 9780387449708

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Statistical Monitoring of Clinical Trials by Michael A. Proschan,K. K. Gordon Lan,Janet Turk Wittes Pdf

The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion ("the B-value") – irrespective of the test statistic. Thus, this book offers statisticians an accessible, incremental approach to understanding Brownian motion as related to clinical trials.

The Lady Tasting Tea

David Salsburg
The Lady Tasting Tea Book PDF

Author : David Salsburg
Publisher : Henry Holt and Company
Page : 352 pages
File Size : 45,6 Mb
Release : 2002-05-01
Category : Mathematics
ISBN : 9781466801783

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The Lady Tasting Tea by David Salsburg Pdf

At a summer tea party in Cambridge, England, a lady states that tea poured into milk tastes differently than that of milk poured into tea. Her notion is shouted down by the scientific minds of the group. But one guest, by the name Ronald Aylmer Fisher, proposes to scientifically test the lady's hypothesis. There was no better person to conduct such a test. For Fisher had brought to the field of statistics an emphasis on controlling the methods for obtaining data and the importance of interpretation. He knew that how the data was gathered and applied was as important as the data themselves. In The Lady Tasting Tea, readers will encounter not only Ronald Fisher's theories (and their repercussions), but the ideas of dozens of men and women whose revolutionary work affects our everyday lives. Writing with verve and wit, author David Salsburg traces the rise and fall of Karl Pearson's theories, explores W. Edwards Deming's statistical methods of quality control (which rebuilt postwar Japan's economy), and relates the story of Stella Cunliff's early work on the capacity of small beer casks at the Guinness brewing factory. The Lady Tasting Tea is not a book of dry facts and figures, but the history of great individuals who dared to look at the world in a new way.

Medical Uses of Statistics

John C. Bailar,David C. Hoaglin
Medical Uses of Statistics Book PDF

Author : John C. Bailar,David C. Hoaglin
Publisher : John Wiley & Sons
Page : 393 pages
File Size : 53,6 Mb
Release : 2012-01-10
Category : Medical
ISBN : 9781118211182

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Medical Uses of Statistics by John C. Bailar,David C. Hoaglin Pdf

A new edition of the classic guide to the use of statistics in medicine, featuring examples from articles in the New England Journal of Medicine Medical Uses of Statistics has served as one of the most influential works on the subject for physicians, physicians-in-training, and a myriad of healthcare experts who need a clear idea of the proper application of statistical techniques in clinical studies as well as the implications of their interpretation for clinical practice. This Third Edition maintains the focus on the critical ideas, rather than the mechanics, to give practitioners and students the resources they need to understand the statistical methods they encounter in modern medical literature. Bringing together contributions from more than two dozen distinguished statisticians and medical doctors, this volume stresses the underlying concepts in areas such as randomized trials, survival analysis, genetics, linear regression, meta-analysis, and risk analysis. The Third Edition includes: Numerous examples based on studies taken directly from the pages of the New England Journal of Medicine Two added chapters on statistics in genetics Two new chapters on the application of statistical methods to studies in epidemiology New chapters on analyses of randomized trials, linear regression, categorical data analysis, meta-analysis, subgroup analyses, and risk analysis Updated chapters on statistical thinking, crossover designs, p-values, survival analysis, and reporting research results A focus on helping readers to critically interpret published results of clinical research Medical Uses of Statistics, Third Edition is a valuable resource for researchers and physicians working in any health-related field. It is also an excellent supplemental book for courses on medicine, biostatistics, and clinical research at the upper-undergraduate and graduate levels. You can also visit the New England Journal of Medicine website for related information.