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Statistics Applied To Clinical Studies

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Statistics Applied To Clinical Studies

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Author : Ton J. Cleophas
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-02-09

Statistics Applied To Clinical Studies written by Ton J. Cleophas and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-02-09 with Medical categories.

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.

Statistics Applied To Clinical Trials

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Author : Ton J. Cleophas
language : en
Publisher: Springer Science & Business Media
Release Date : 2008-12-16

Statistics Applied To Clinical Trials written by Ton J. Cleophas and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-12-16 with Mathematics categories.

In clinical medicine appropriate statistics has become indispensable to evaluate treatment effects. Randomized controlled trials are currently the only trials that truly provide evidence-based medicine. Evidence based medicine has become crucial to optimal treatment of patients. We can define randomized controlled trials by using Christopher J. Bulpitt’s definition “a carefully and ethically designed experiment which includes the provision of adequate and appropriate controls by a process of randomization, so that precisely framed questions can be answered”. The answers given by randomized controlled trials constitute at present the way how patients should be clinically managed. In the setup of such randomized trial one of the most important issues is the statistical basis. The randomized trial will never work when the statistical grounds and analyses have not been clearly defined beforehand. All endpoints should be clearly defined in order to perform appropriate power calculations. Based on these power calculations the exact number of available patients can be calculated in order to have a sufficient quantity of individuals to have the predefined questions answered. Therefore, every clinical physician should be capable to understand the statistical basis of well performed clinical trials. It is therefore a great pleasure that Drs. T. J. Cleophas, A. H. Zwinderman, and T. F. Cleophas have published a book on statistical analysis of clinical trials. The book entitled “Statistics Applied to Clinical Trials” is clearly written and makes complex issues in statistical analysis transparant.

Statistics Applied To Clinical Trials

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Author : Ton J. Cleophas
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-11-11

In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm the hypotheses to be tested. This phenomenon was attributed to low sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were recognized and, subsequently, were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses, and so on. Such flaws, mainly of a technical nature, have been largely corrected and led to trials after 1970 being of significantly higher quality. The past decade has focused, in addition to technical aspects, on the need for circumspection in the planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial organs, including ethics committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. This book not only explains classical statistical analyses of clinical trials, but also addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, and meta-analyses, and provides a framework of the best statistical methods currently available for such purposes. This book is not only useful for investigators involved in the field of clinical trials, but also for all physicians who wish to better understand the data of trials as currently published.

Statistics Applied To Clinical Trials

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Author : Ton J. Cleophas
language : en
Publisher: Springer Science & Business Media
Release Date : 2003-01-31

The current book can be studied together with the texbook Statistics Applied To Clinical Trials by the same authors, or separately. The authors often hear that students have difficulties in understanding statistics from a textbook and that self-assessment through exercises and examples is required. Rather than trying to be complete, this book focuses on the main aspects, including the test statistics generally used for the primary analysis of continuous and proportional data from randomized controlled clinical trials. In the past few years statistical analysis has increasingly been left to the computer, and clinical investigators are at a loss to understand the limitations of the research and its statistical analysis, on the one hand, while on the other hand, statistical results are often overemphasized. This self-assessment book is not only useful for investigators involved in the field of clinical trials, but also for every physician who wishes to better understand the data from trials as published currently.

Medical Uses Of Statistics

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Author : John C. Bailar III
language : en
Publisher: CRC Press
Release Date : 2019-05-20

Medical Uses Of Statistics written by John C. Bailar III and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-20 with Mathematics categories.

This work explains the purpose of statistical methods in medical studies and analyzes the statistical techniques used by clinical investigators, with special emphasis on studies published in "The New England Journal of Medicine". It clarifies fundamental concepts of statistical design and analysis, and facilitates the understanding of research results.

Statistics Applied To Clinical Trials

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Author : Ton J. M. Cleophas
language : en
Publisher: Springer Science & Business Media
Release Date : 2002

Statistics Applied To Clinical Trials written by Ton J. M. Cleophas and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002 with Clinical trials categories.

This book not only explains classical statistical analyses of clinical trials, but addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, and meta-analyses, and provides a framework of the best statistical methods currently available for such purposes. The book is not only useful for investigators involved in the field of clinical trials, but also for all physicians who wish to better understand the data of trials.

Introduction To Statistical Methods For Clinical Trials

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Author : Thomas D. Cook
language : en
Publisher: CRC Press
Release Date : 2007-11-19

Introduction To Statistical Methods For Clinical Trials written by Thomas D. Cook and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-19 with Mathematics categories.

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 Use Of Restricted Significance Tests In Clinical Trials

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Author : David S. Salsburg
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06

The Use Of Restricted Significance Tests In Clinical Trials written by David S. Salsburg and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Mathematics categories.

The reader will soon find that this is more than a "how-to-do-it" book. It describes a philosophical approach to the use of statistics in the analysis of clinical trials. I have come gradually to the position described here, but I have not come that way alone. This approach is heavily influenced by my reading the papers of R.A. Fisher, F.S. Anscombe, F. Mosteller, and J. Neyman. But the most important influences have been those of my medical colleagues, who had important real-life medical questions that needed to be answered. Statistical methods depend on abstract mathematical theorems and often complicated algorithms on the computer. But these are only a means to an end, because in the end the statistical techniques we apply to clinical studies have to provide useful answers. When I was studying martingales and symbolic logic in graduate school, my wife, Fran, had to be left out of the intellectual excitement. But, as she looked on, she kept asking me how is this knowledge useful. That question, what can you do with this? haunted my studies. When I began working in bio statistics, she continued asking me where it was all going, and I had to explain what I was doing in terms of the practical problems that were being ad dressed.

Small Clinical Trials

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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2001-01-01

Small Clinical Trials written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-01-01 with Medical categories.

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.

Missing Data In Clinical Studies

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Author : Geert Molenberghs
language : en
Publisher: John Wiley & Sons
Release Date : 2007-04-04

Missing Data In Clinical Studies written by Geert Molenberghs and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-04-04 with Medical categories.

Missing Data in Clinical Studies provides a comprehensive account of the problems arising when data from clinical and related studies are incomplete, and presents the reader with approaches to effectively address them. The text provides a critique of conventional and simple methods before moving on to discuss more advanced approaches. The authors focus on practical and modeling concepts, providing an extensive set of case studies to illustrate the problems described. Provides a practical guide to the analysis of clinical trials and related studies with missing data. Examines the problems caused by missing data, enabling a complete understanding of how to overcome them. Presents conventional, simple methods to tackle these problems, before addressing more advanced approaches, including sensitivity analysis, and the MAR missingness mechanism. Illustrated throughout with real-life case studies and worked examples from clinical trials. Details the use and implementation of the necessary statistical software, primarily SAS. Missing Data in Clinical Studies has been developed through a series of courses and lectures. Its practical approach will appeal to applied statisticians and biomedical researchers, in particular those in the biopharmaceutical industry, medical and public health organisations. Graduate students of biostatistics will also find much of benefit.

Statistics Applied To Clinical Studies

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