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Statistics Applied To Clinical Trials


Statistics Applied To Clinical Trials
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Statistics Applied To Clinical Trials


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


Statistics Applied To Clinical Trials
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Author : Ton J. Cleophas
language : en
Publisher: Springer Science & Business Media
Release Date : 2016-04-30

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 2016-04-30 with Medical categories.


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 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, etc. Such flaws, mainly of a technical nature, have been largely corrected and led to trials after 1970 being of significantly better quality than before. The past decade has focused, in addition to technical aspects, on the need for circumspection in planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial bodies, 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 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 as currently published.



Statistics Applied To Clinical Trials


Statistics Applied To Clinical Trials
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Author : Ton J. Cleophas
language : en
Publisher: Springer Science & Business Media
Release Date : 2006

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 2006 with Mathematics categories.


This title explains statistical analyses of clinical trials, as well as novel issues, such as equivalence testing, interim analyses, sequential analyses and meta-analyses.



Statistics Applied To Clinical Studies


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.



Strategy And Statistics In Clinical Trials


Strategy And Statistics In Clinical Trials
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Author : Joseph Tal
language : en
Publisher:
Release Date : 2011

Strategy And Statistics In Clinical Trials written by Joseph Tal and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with categories.


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.



Sharing Clinical Trial Data


Sharing Clinical Trial Data
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-04-20

Sharing Clinical Trial Data 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 2015-04-20 with Medical categories.


Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.



Sequential Experimentation In Clinical Trials


Sequential Experimentation In Clinical Trials
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Author : Jay Bartroff
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-12

Sequential Experimentation In Clinical Trials written by Jay Bartroff 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 2012-12-12 with Medical categories.


Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information. Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.



Statistics Applied To Clinical Trials


Statistics Applied To Clinical Trials
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Author : Ton J. Cleophas
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06

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 2012-12-06 with Medical categories.


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.



Statistics Applied To Clinical Trials


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 Medical 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.



Clinical Trials


Clinical Trials
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Author : Duolao Wang
language : en
Publisher: Remedica
Release Date : 2006

Clinical Trials written by Duolao Wang and has been published by Remedica this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Medical categories.


This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.