Clinical Trials

Author: Steven Piantadosi
Publisher: John Wiley & Sons
ISBN: 1118959213
Size: 28.24 MB
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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.

Clinical Trials

Author: Steven Piantadosi
Publisher: John Wiley & Sons
ISBN: 1118625854
Size: 17.36 MB
Format: PDF, ePub
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Learn rigorous statistical methods to ensure valid clinical trials This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and 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 commonsense solutions. The author bases the revisions and updates on his own classroom experience, as well as feedback from students, instructors, and medical and statistical professionals involved in clinical trials. The Second Edition greatly expands its coverage, ranging from statistical principles to controversial topics, including alternative medicine and ethics. 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 Edition will discover completely new chapters, including: * Contexts for clinical trials * Statistical perspectives * Translational clinical trials * Dose-finding and dose-ranging designs Each chapter is accompanied by a summary to reinforce the key points. Revised discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge, and updated references are provided to direct readers to the most recent literature. This text distinguishes itself with its accessible and broad coverage of statistical design methods--the crucial building blocks of clinical trials and medical research. Readers learn to conduct clinical trials that produce valid qualitative results backed by rigorous statistical methods.

Preventing And Treating Missing Data In Longitudinal Clinical Trials

Author: Craig H. Mallinckrodt
Publisher: Cambridge University Press
ISBN: 1107311365
Size: 60.96 MB
Format: PDF, Kindle
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Recent decades have brought advances in statistical theory for missing data, which, combined with advances in computing ability, have allowed implementation of a wide array of analyses. In fact, so many methods are available that it can be difficult to ascertain when to use which method. This book focuses on the prevention and treatment of missing data in longitudinal clinical trials. Based on his extensive experience with missing data, the author offers advice on choosing analysis methods and on ways to prevent missing data through appropriate trial design and conduct. He offers a practical guide to key principles and explains analytic methods for the non-statistician using limited statistical notation and jargon. The book's goal is to present a comprehensive strategy for preventing and treating missing data, and to make available the programs used to conduct the analyses of the example dataset.

Introduction To Statistical Methods For Clinical Trials

Author: Thomas D. Cook
Publisher: CRC Press
ISBN: 1584880279
Size: 40.33 MB
Format: PDF, ePub, Docs
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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.

Bayesian Adaptive Methods For Clinical Trials

Author: Scott M. Berry
Publisher: CRC Press
ISBN: 9781439825518
Size: 58.40 MB
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Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer’s disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISPY-2 trials. In the following chapter on late (Phase III) studies, the authors emphasize modern adaptive methods and seamless Phase II–III trials for maximizing information usage and minimizing trial duration. They also describe a case study of a recently approved medical device to treat atrial fibrillation. The concluding chapter covers key special topics, such as the proper use of historical data, equivalence studies, and subgroup analysis. For readers involved in clinical trials research, this book significantly updates and expands their statistical toolkits. The authors provide many detailed examples drawing on real data sets. The R and WinBUGS codes used throughout are available on supporting websites. Scott Berry talks about the book on the CRC Press YouTube Channel.

Statistical Design And Analysis Of Clinical Trials

Author: Weichung Joe Shih
Publisher: CRC Press
ISBN: 1482250500
Size: 43.89 MB
Format: PDF, Mobi
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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.

Clinicaltrials

Author: Curtis L. Meinert
Publisher: OUP USA
ISBN: 0195387880
Size: 55.38 MB
Format: PDF
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The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.

Latent Curve Models

Author: Kenneth A. Bollen
Publisher: John Wiley & Sons
ISBN: 047145592X
Size: 42.54 MB
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An effective technique for data analysis in the social sciences The recent explosion in longitudinal data in the social sciences highlights the need for this timely publication. Latent Curve Models: A Structural Equation Perspective provides an effective technique to analyze latent curve models (LCMs). This type of data features random intercepts and slopes that permit each case in a sample to have a different trajectory over time. Furthermore, researchers can include variables to predict the parameters governing these trajectories. The authors synthesize a vast amount of research and findings and, at the same time, provide original results. The book analyzes LCMs from the perspective of structural equation models (SEMs) with latent variables. While the authors discuss simple regression-based procedures that are useful in the early stages of LCMs, most of the presentation uses SEMs as a driving tool. This cutting-edge work includes some of the authors' recent work on the autoregressive latent trajectory model, suggests new models for method factors in multiple indicators, discusses repeated latent variable models, and establishes the identification of a variety of LCMs. This text has been thoroughly class-tested and makes extensive use of pedagogical tools to aid readers in mastering and applying LCMs quickly and easily to their own data sets. Key features include: Chapter introductions and summaries that provide a quick overview of highlights Empirical examples provided throughout that allow readers to test their newly found knowledge and discover practical applications Conclusions at the end of each chapter that stress the essential points that readers need to understand for advancement to more sophisticated topics Extensive footnoting that points the way to the primary literature for more information on particular topics With its emphasis on modeling and the use of numerous examples, this is an excellent book for graduate courses in latent trajectory models as well as a supplemental text for courses in structural modeling. This book is an excellent aid and reference for researchers in quantitative social and behavioral sciences who need to analyze longitudinal data.