Download or read book The Use of Restricted Significance Tests in Clinical Trials written by David S. Salsburg and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Use of Restricted Significance Tests in Clinical Trials written by David Salsburg and published by . This book was released on 1992-01-01 with total page 173 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book A Manager s Guide to the Design and Conduct of Clinical Trials written by Phillip I. Good and published by John Wiley & Sons. This book was released on 2006-04-28 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This newly updated edition of the benchmark guide tocomputer-assisted clinical trials provides a comprehensive primerfor prospective managers. It covers every critical issue of thedesign and conduct of clinical trials, including study design,organization, regulatory agency liaison, data collection andanalysis, as well as recruitment, software, monitoring, andreporting. Keeping the same user-friendly format as the original, this SecondEdition features new examples and the latest developments inregulatory guidelines, such as e-submission procedures andcomputerized direct data acquisition. The new edition also reflectsthe increasing globalization of clinical trial activities, andincludes new information about international standards andprocedures, including the Common Technical Document and CDISCstandards. This step-by-step guide is supported by handy checklists andextracts from submitted protocols. Experienced author andconsultant Phillip Good incorporateshumorous yet instructiveanecdotes to illustrate common pitfalls. Based on the provenindustrial formula of planning, implementing, and finallyperforming essential checks, the book's three sections-"Plan,""Do," and "Check"-includethe following material: * Should the trials be conducted? * Put it in the computer and keep it there * Staffing for success * Designing trials and determining sample size * Budgeting * Recruiting and retaining patients and physicians * Data management * Monitoring the trials * Data analysis * After action review * Exception handling Executive and managerial professionals involved in the design andanalysis of clinical experiments, along with clinical researchassociates, biostatisticians, and students in public health willfind A Manager's Guide an indispensable resource. Praise for the First Edition: ". . . readable, informative and at times witty . . . never stopsbeing concise and well written . . . a book worth a read . .." -Statistics in Medicine "The book is very prescriptive and full of lists and tables withwhich to guide managers in making effective decisions in usingcomputer-assisted clinical trials in pharmaceutical studies."-Technometrics "This book is must-have reading for anyone in the business . .." -Clinical Chemistry

Download or read book Biostatistics in Clinical Trials written by Carol K. Redmond and published by John Wiley & Sons. This book was released on 2001-04-25 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second volume in the Wiley reference series in Biostatistics. Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in: Bayesian methods Benefit/risk assessment Cost-effectiveness Ethics Fraud With exceptional contributions from leading experts in academia, government and industry, Biostatistics in Clinical Trials has been designed to complement existing texts by providing extensive, up-to-date coverage and introducing the reader to the research literature. Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials: Includes concise definitions and introductions to numerous concepts found in current literature Discusses the software and textbooks available Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts Biostatistics in Clinical Trials offers both academics and practitioners from various disciplines and settings, such as universities, the pharmaceutical industry and clinical research organisations, up-to-date information as well as references to assist professionals involved in the design and conduct of clinical trials.

Download or read book Clinical Trials in Neurology written by Roberto J. Guiloff and published by Springer Science & Business Media. This book was released on 2013-03-14 with total page 537 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials in Neurology comprehensively tackles the methodology and design of clinical trials in neurological disease. A general section deals with the ethical aspects, drug development and regulatory requirements, basic trial designs and the statistics used. A diseases section tackles specific aspects of disorders, focusing on the relevant ethical issues, outcome variables and experience with large multicentre trials.

Download or read book Statistical Monitoring of Clinical Trials written by Michael A. Proschan and published by Springer Science & Business Media. This book was released on 2006-12-31 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition “All medical statisticians involved in clinical trials should read this book…” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.

Download or read book Design of Observational Studies written by Paul R. Rosenbaum and published by Springer Nature. This book was released on 2020-07-13 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition of Design of Observational Studies is both an introduction to statistical inference in observational studies and a detailed discussion of the principles that guide the design of observational studies. An observational study is an empiric investigation of effects caused by treatments when randomized experimentation is unethical or infeasible. Observational studies are common in most fields that study the effects of treatments on people, including medicine, economics, epidemiology, education, psychology, political science and sociology. The quality and strength of evidence provided by an observational study is determined largely by its design. Design of Observational Studies is organized into five parts. Chapters 2, 3, and 5 of Part I cover concisely many of the ideas discussed in Rosenbaum’s Observational Studies (also published by Springer) but in a less technical fashion. Part II discusses the practical aspects of using propensity scores and other tools to create a matched comparison that balances many covariates, and includes an updated chapter on matching in R. In Part III, the concept of design sensitivity is used to appraise the relative ability of competing designs to distinguish treatment effects from biases due to unmeasured covariates. Part IV is new to this edition; it discusses evidence factors and the computerized construction of more than one comparison group. Part V discusses planning the analysis of an observational study, with particular reference to Sir Ronald Fisher’s striking advice for observational studies: "make your theories elaborate." This new edition features updated exploration of causal influence, with four new chapters, a new R package DOS2 designed as a companion for the book, and discussion of several of the latest matching packages for R. In particular, DOS2 allows readers to reproduce many analyses from Design of Observational Studies.

Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1992 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.

Download or read book Clinical Hepatology written by G. Csomos and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hepatology has come of age in the last decades. Biology of the liver has flour ished long before. As the largest homogeneous organ of the body the liver served as useful model in the development of biochemistry and related discip lines. Only gradually were these biological investigations applied to the clinical study of liver disease. This was particularly stimulated by the recognition that in the greater part of the world, the developing countries and what we now call the Third World, liver disease represents a major threat to overall public health. It leads to morbidity and mortality of persons in their productive years from liver cancer, cirrhosis and parasitic disease, particularly, schistosomiasis. Moreover, the growing emphasis on the social impact of diseases focused on disorders of the liver because malnutrition, poverty, and drug addiction contrib ute greatly to their spread. This is compounded by the increase of alcohol abuse, recently on the rise even in the developing countries. Concern with envi ronmental pollution has also raised the interest in liver diseases, in part because the liver acts as a guardian against polluting chemicals and in part because it is considered, possibly to an exaggerated degree, a vulnerable target of such chemicals.

Download or read book National Library of Medicine Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1992 with total page 1332 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Design and Analysis of Sequential Clinical Trials written by John Whitehead and published by . This book was released on 1992 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a description of an important class of sequential designs for comparative clinical trials, giving consideration to the practical advantages and disadvantages of each method. This edition features many real examples of clinical trial data as well as simulation results.

Download or read book Permutation Parametric and Bootstrap Tests of Hypotheses written by Phillip I. Good and published by Springer Science & Business Media. This book was released on 2005-12-19 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Previous edition sold over 1400 copies worldwide. This new edition includes many more real-world illustrations from biology, business, clinical trials, economics, geology, law, medicine, social science and engineering along with twice the number of exercises.

Download or read book Dose Finding in Drug Development written by Naitee Ting and published by Springer Science & Business Media. This book was released on 2006-12-29 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined.

Download or read book An Introduction to Stochastic Processes and Their Applications written by Petar Todorovic and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text on stochastic processes and their applications is based on a set of lectures given during the past several years at the University of California, Santa Barbara (UCSB). It is an introductory graduate course designed for classroom purposes. Its objective is to provide graduate students of statistics with an overview of some basic methods and techniques in the theory of stochastic processes. The only prerequisites are some rudiments of measure and integration theory and an intermediate course in probability theory. There are more than 50 examples and applications and 243 problems and complements which appear at the end of each chapter. The book consists of 10 chapters. Basic concepts and definitions are pro vided in Chapter 1. This chapter also contains a number of motivating ex amples and applications illustrating the practical use of the concepts. The last five sections are devoted to topics such as separability, continuity, and measurability of random processes, which are discussed in some detail. The concept of a simple point process on R+ is introduced in Chapter 2. Using the coupling inequality and Le Cam's lemma, it is shown that if its counting function is stochastically continuous and has independent increments, the point process is Poisson. When the counting function is Markovian, the sequence of arrival times is also a Markov process. Some related topics such as independent thinning and marked point processes are also discussed. In the final section, an application of these results to flood modeling is presented.

Download or read book Statistical Methods in Molecular Evolution written by Rasmus Nielsen and published by Springer Science & Business Media. This book was released on 2005-04-21 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the field of molecular evolution, inferences about past evolutionary events are made using molecular data from currently living species. With the availability of genomic data from multiple related species, molecular evolution has become one of the most active and fastest growing fields of study in genomics and bioinformatics. Most studies in molecular evolution rely heavily on statistical procedures based on stochastic process modelling and advanced computational methods including high-dimensional numerical optimization and Markov Chain Monte Carlo. This book provides an overview of the statistical theory and methods used in studies of molecular evolution. It includes an introductory section suitable for readers that are new to the field, a section discussing practical methods for data analysis, and more specialized sections discussing specific models and addressing statistical issues relating to estimation and model choice. The chapters are written by the leaders of field and they will take the reader from basic introductory material to the state-of-the-art statistical methods. This book is suitable for statisticians seeking to learn more about applications in molecular evolution and molecular evolutionary biologists with an interest in learning more about the theory behind the statistical methods applied in the field. The chapters of the book assume no advanced mathematical skills beyond basic calculus, although familiarity with basic probability theory will help the reader. Most relevant statistical concepts are introduced in the book in the context of their application in molecular evolution, and the book should be accessible for most biology graduate students with an interest in quantitative methods and theory. Rasmus Nielsen received his Ph.D. form the University of California at Berkeley in 1998 and after a postdoc at Harvard University, he assumed a faculty position in Statistical Genomics at Cornell University. He is currently an Ole Rømer Fellow at the University of Copenhagen and holds a Sloan Research Fellowship. His is an associate editor of the Journal of Molecular Evolution and has published more than fifty original papers in peer-reviewed journals on the topic of this book. From the reviews: "...Overall this is a very useful book in an area of increasing importance." Journal of the Royal Statistical Society "I find Statistical Methods in Molecular Evolution very interesting and useful. It delves into problems that were considered very difficult just several years ago...the book is likely to stimulate the interest of statisticians that are unaware of this exciting field of applications. It is my hope that it will also help the 'wet lab' molecular evolutionist to better understand mathematical and statistical methods." Marek Kimmel for the Journal of the American Statistical Association, September 2006 "Who should read this book? We suggest that anyone who deals with molecular data (who does not?) and anyone who asks evolutionary questions (who should not?) ought to consult the relevant chapters in this book." Dan Graur and Dror Berel for Biometrics, September 2006 "Coalescence theory facilitates the merger of population genetics theory with phylogenetic approaches, but still, there are mostly two camps: phylogeneticists and population geneticists. Only a few people are moving freely between them. Rasmus Nielsen is certainly one of these researchers, and his work so far has merged many population genetic and phylogenetic aspects of biological research under the umbrella of molecular evolution. Although Nielsen did not contribute a chapter to his book, his work permeates all its chapters. This book gives an overview of his interests and current achievements in molecular evolution. In short, this book should be on your bookshelf." Peter Beerli for Evolution, 60(2), 2006