Statistics Applied to Clinical Trials

Author: Ton J. Cleophas
Publisher: Springer Science & Business Media
ISBN: 9401002851
Format: PDF, ePub
Download and Read
The authors have taught statistics and given statistics workshops in France and the Netherlands for almost 4 years by now. Their material, mainly on power point, consists of 12 lectures that have been continuously changed and improved by interaction with various audiences. For the purpose of the current book simple English text has been added to the formulas and figures, and the power points sheets have been rewritten in the format given by Kluwer Academic Publishers. Cartoons have been removed, since this is not so relevant for the transmission of thought through a written text, and at the end of each lecture (chapter) a representative number of questions and exercises for self-assessment have been added. At the end of the book detailed answers to the questions and exercises per lecture are given. The book has been produced with the same size and frontpage as the textbook "Statistics Applied To Clinical Trials" by the same authors and edited by same publishers ( 2nd Edition, DordrechtiBostonlLondon, 2002), and can be applied together with the current self-assessment book or separately. The current self-assessment book is different from the texbook, because it focuses on the most important aspects rather than trying to be complete. So, it does not deal with all of the subjects assessed in the texbook. Instead, it repeats on and on the principle things that are needed for every analysis, and it gives many examples that are further explained by arrows in the figures.

Strategy and Statistics in Clinical Trials

Author: Joseph Tal
Publisher: Academic Press
ISBN: 0123869099
Format: PDF, ePub, Mobi
Download and Read
Strategy and Statistics in Clinical Trials is for all individuals engaged in clinical research, including professors, physicians, researchers in corporate and government laboratories, nurses, members of the allied health professions, and post-doctoral and graduate students who are potentially less exposed to understanding the pivotal role of statistics. . Enables nonstatisticians 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.

Introduction to Statistical Methods for Clinical Trials

Author: Thomas D. Cook
Publisher: CRC Press
ISBN: 1584880279
Format: PDF, ePub
Download and Read
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.

Statistics Applied to Clinical Studies

Author: Ton J. Cleophas
Publisher: Springer Science & Business Media
ISBN: 940072862X
Format: PDF, ePub, Mobi
Download and Read
Thanks to the omnipresent computer, current statistics can include data files of many thousands of values, and can perform any exploratory analysis in less than seconds. This development, however fascinating, generally does not lead to simple results. We should not forget that clinical studies are, mostly, for confirming prior hypotheses based on sound arguments, and the simplest tests provide the best power and are adequate for such studies. In the past few years the authors of this 5th edition, as teachers and research supervisors in academic and top-clinical facilities, have been able to closely observe the latest developments in the field of clinical data analysis, and they have been able to assess their performance. In this 5th edition the 47 chapters of the previous edition have been maintained and upgraded according to the current state of the art, and 20 novel chapters have been added after strict selection of the most valuable and promising novel methods. The novel methods are explained using practical examples and step-by-step analyses readily accessible for non-mathematicians. All of the novel chapters have been internationally published by the authors in peer-reviewed journal, including the American Journal of Therapeutics, the European Journal of Clinical Investigation, The International journal of Clinical Pharmacology and therapeutics, and other journals, and permission is granted by all of them to use this material in the current book. We should add that the authors are well-qualified in their fields of knowledge. Professor Zwinderman is president-elect of the International Society of Biostatistics, and Professor Cleophas is past-president of the American College of Angiology. From their expertise they should be able to make adequate selections of modern methods for clinical data analysis for the benefit of physicians, students, and investigators. The authors, although from a different discipline, one clinician and one statistician, have been working and publishing together for over 10 years, and their research of statistical methodology can be characterized as a continued effort to demonstrate that statistics is not mathematics but rather a discipline at the interface of biology and mathematics. They firmly believe that any reader can benefit from this clinical approach to statistical data analysis.

Applied Statistics in Biomedicine and Clinical Trials Design

Author: Zhen Chen
Publisher: Springer
ISBN: 3319126946
Format: PDF, Mobi
Download and Read
This volume is a unique combination of papers that cover critical topics in biostatistics from academic, government, and industry perspectives. The 6 sections cover Bayesian methods in biomedical research; Diagnostic medicine and classification; Innovative Clinical Trials Design; Modelling and Data Analysis; Personalized Medicine; and Statistical Genomics. The real world applications are in clinical trials, diagnostic medicine and genetics. The peer-reviewed contributions were solicited and selected from some 400 presentations at the annual meeting of the International Chinese Statistical Association (ICSA), held with the International Society for Biopharmaceutical Statistics (ISBS). The conference was held in Bethesda in June 2013, and the material has been subsequently edited and expanded to cover the most recent developments.

Statistical Aspects of the Design and Analysis of Clinical Trials

Author: Brian S Everitt
Publisher: World Scientific
ISBN: 1783260777
Format: PDF, ePub
Download and Read
Fully updated, this revised edition describes the statistical aspects of both the design and analysis of trials, with particular emphasis on the more recent methods of analysis. About 8000 clinical trials are undertaken annually in all areas of medicine, from the treatment of acne to the prevention of cancer. Correct interpretation of the data from such trials depends largely on adequate design and on performing the appropriate statistical analyses. This book provides a useful guide to medical statisticians and others faced with the often difficult problems of designing and analysing clinical trials. Contents:An Introduction to Clinical TrialsTreatment Allocation, the Size of Trials and Reporting ResultsMonitoring Trial Progress: Outcome Measures, Compliance, Dropouts and Interim AnalysesBasic Analyses of Clinical Trials, the Generalised Linear Model and the Economic Evaluation of TrialsSimple Approaches to the Analysis of Longitudinal Data from Clinical TrialsMultivariate Normal Regression Models for Longitudinal Data from Clinical TrialsModels for Non-Normal Longitudinal Data from Clinical TrialsSurvival AnalysisBayesian Methods Longitudinal DataMeta-Analysis Readership: Applied statisticians in medicine, researchers dealing with clinical trials and pharmaceutical companies. Keywords:Clinical Trials;Longitudinal Data;Random Effects Models;Dropouts;Survival Analysis, Bayesian MethodsReviews:“… given a keen amateur interest and an ability to skip the occasional rather daunting-looking equation this book is surprisingly accessible … There's an introductory chapter containing an excellent historical overview.”Transactions of Royal Society of Tropical Medicine and Hygiene “In providing a concise description of the statistical aspects of the design and analysis of clinical trials, free of any major typographical errors, the authors have succeeded. Those concerned with the correct design and analysis of clinical trials, but wishing to avoid either the advanced theoretical aspects or too much focus on application of methodologies, will find this book to be very accessible with relatively up-to-date references.”Pharmaceutical Statistics

Clinical Trials

Author: Steven Piantadosi
Publisher: John Wiley & Sons
ISBN: 1118959213
Format: PDF, Kindle
Download and Read
Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies This Third Edition builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the principles of design for various types of clinical trials, and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides common sense solutions. All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area. The authors bases current revisions and updates on his own experience, classroom instruction, and feedback from teachers and medical and statistical professionals involved in clinical trials. The Third Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including alternative medicine and ethics, middle development, comparative studies, and adaptive designs. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First and Second Editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections. In addition, this book: • Features accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research -- now complete with new chapters on overall development, middle development, comparative studies, and adaptive designs • Teaches readers to design clinical trials that produce valid qualitative results backed by rigorous statistical methods • Contains an introduction and summary in each chapter to reinforce key points • Includes discussion questions to stimulate critical thinking and help readers understand how they can apply their newfound knowledge • Provides extensive references to direct readers to the most recent literature, and there are numerous new or revised exercises throughout the book Clinical Trials: A Methodologic Perspective, Third Edition is a textbook accessible to advanced undergraduate students in the quantitative sciences, graduate students in public health and the life sciences, physicians training in clinical research methods, and biostatisticians and epidemiologists. Steven Piantadosi, MD, PhD, is the Phase One Foundation Distinguished Chair and Director of the Samuel Oschin Cancer Institute, and Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California. Dr. Piantadosi is one of the world’s leading experts in the design and analysis of clinical trials for cancer research. He has taught clinical trials methods extensively in formal courses and short venues. He has advised numerous academic programs and collaborations nationally regarding clinical trial design and conduct, and has served on external advisory boards for the National Institutes of Health and other prominent cancer programs and centers. The author of more than 260 peer-reviewed scientific articles, Dr. Piantadosi has published extensively on research results, clinical applications, and trial methodology. While his papers have contributed to many areas of oncology, he has also collaborated on diverse studies outside oncology including lung disease and degenerative neurological disease.

Analysis of Clinical Trials Using SAS

Author: Alex Dmitrienko
Publisher: SAS Institute
ISBN: 9781590477809
Format: PDF, ePub, Mobi
Download and Read
In Analysis of Clinical Trials Using SAS: A Practical Guide, Alex Dmitrienko, Geert Molenberghs, Christy Chuang-Stein, and Walter Offen bridge the gap between modern statistical methodology and real-world clinical trial applications. Step-by-step instructions illustrated with examples from actual trials and case studies serve to define a statistical method and its relevance in a clinical trials setting and to illustrate how to implement the method rapidly and efficiently using the power of SAS software. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials, including analysis of stratified data, incomplete data, multiple inferences, issues arising in safety and efficacy monitoring, and reference intervals for extreme safety and diagnostic measurements. Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience compiled in this book. Numerous ready-to-use SAS macros and example code are included. This book is part of the SAS Press program.

Statistical Design and Analysis of Clinical Trials

Author: Weichung Joe Shih
Publisher: CRC Press
ISBN: 1482250500
Format: PDF, Docs
Download and Read
Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. Teach Your Students How to Design, Monitor, and Analyze Clinical Trials 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, explain the concept of different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. Turn Your Students into Better Clinical Trial Investigators This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students a multidisciplinary understanding of the concepts and techniques involved in designing and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students in (bio)statistics, epidemiology, medicine, pharmacy, and public health.