Download or read book Some Hypothesis Testing Results for Two way Linear Models in Clinical Trials written by Bin Cheng and published by . This book was released on 2004 with total page 96 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 Analysis of Clinical Trials Using SAS written by Alex Dmitrienko and published by SAS Institute. This book was released on 2017-07-17 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.

Download or read book Learning Statistics with R written by Daniel Navarro and published by Lulu.com. This book was released on 2013-01-13 with total page 617 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Learning Statistics with R" covers the contents of an introductory statistics class, as typically taught to undergraduate psychology students, focusing on the use of the R statistical software and adopting a light, conversational style throughout. The book discusses how to get started in R, and gives an introduction to data manipulation and writing scripts. From a statistical perspective, the book discusses descriptive statistics and graphing first, followed by chapters on probability theory, sampling and estimation, and null hypothesis testing. After introducing the theory, the book covers the analysis of contingency tables, t-tests, ANOVAs and regression. Bayesian statistics are covered at the end of the book. For more information (and the opportunity to check the book out before you buy!) visit http://ua.edu.au/ccs/teaching/lsr or http://learningstatisticswithr.com

Download or read book Medical Statistics written by Jennifer Peat and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Holistic approach to understanding medical statistics This hands-on guide is much more than a basic medical statistics introduction. It equips you with the statistical tools required for evidence-based clinical research. Each chapter provides a clear step-by-step guide to each statistical test with practical instructions on how to generate and interpret the numbers, and present the results as scientific tables or graphs. Showing you how to: analyse data with the help of data set examples (Click here to download datasets) select the correct statistics and report results for publication or presentation understand and critically appraise results reported in the literature Each statistical test is linked to the research question and the type of study design used. There are also checklists for critically appraising the literature and web links to useful internet sites. Clear and concise explanations, combined with plenty of examples and tabulated explanations are based on the authors’ popular medical statistics courses. Critical appraisal guidelines at the end of each chapter help the reader evaluate the statistical data in their particular contexts.

Download or read book Group Sequential Methods with Applications to Clinical Trials written by Christopher Jennison and published by CRC Press. This book was released on 1999-09-15 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Academic Press. This book was released on 2017-11-17 with total page 826 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and "omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. - Features input from experts in the field dedicated to translating scientific research from bench to bedside and back - Provides expanded coverage of global clinical research - Contains hands-on, practical suggestions, illustrations, and examples throughout - Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting

Download or read book Biostatistics for Medical and Biomedical Practitioners written by Julien I. E. Hoffman and published by Academic Press. This book was released on 2015-09-03 with total page 772 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biostatistics for Practitioners: An Interpretative Guide for Medicine and Biology deals with several aspects of statistics that are indispensable for researchers and students across the biomedical sciences. The book features a step-by-step approach, focusing on standard statistical tests, as well as discussions of the most common errors. The book is based on the author's 40+ years of teaching statistics to medical fellows and biomedical researchers across a wide range of fields. - Discusses how to use the standard statistical tests in the biomedical field, as well as how to make statistical inferences (t test, ANOVA, regression etc.) - Includes non-standards tests, including equivalence or non-inferiority testing, extreme value statistics, cross-over tests, and simple time series procedures such as the runs test and Cusums - Introduces procedures such as multiple regression, Poisson regression, meta-analysis and resampling statistics, and provides references for further studies

Download or read book Concise Encyclopedia of Biostatistics for Medical Professionals written by Abhaya Indrayan and published by CRC Press. This book was released on 2016-11-25 with total page 729 pages. Available in PDF, EPUB and Kindle. Book excerpt: Concise Encyclopedia of Biostatistics for Medical Professionals focuses on conceptual knowledge and practical advice rather than mathematical details, enhancing its usefulness as a reference for medical professionals. The book defines and describes nearly 1000 commonly and not so commonly used biostatistical terms and methods arranged in alphabetical order. These range from simple terms, such as mean and median to advanced terms such as multilevel models and generalized estimating equations. Synonyms or alternative phrases for each topic covered are listed with a reference to the topic.

Download or read book Statistics Applied to Clinical Trials written by Ton J. Cleophas and published by Springer Science & Business Media. This book was released on 2013-11-11 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Biosimilars and Interchangeable Biologics written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-30 with total page 638 pages. Available in PDF, EPUB and Kindle. Book excerpt: What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Download or read book Veterinary Toxicology written by Ramesh C Gupta and published by Academic Press. This book was released on 2012-04-23 with total page 1455 pages. Available in PDF, EPUB and Kindle. Book excerpt: Veterinary Toxicology, 2nd Edition, is a unique single reference that teaches the basic principles of veterinary toxicology and builds upon these principles to offer an essential clinical resource for those practicing in the field. This new edition brings together insights from qualified and well-experienced authorities across all areas of veterinary toxicology to provide an authoritative and in-depth look at all facets of veterinary toxicology, including target organ toxicity, melamine and cyanuric acid, toxicogenomics, chemical terrorism and nanoparticles. While most comparable texts are primarily directed toward the field of human toxicology, this is the one text needed to thoroughly prepare future veterinarians on the newest approaches for diagnosing poisoning cases in all animals from chemicals and plants of a diverse nature as a result of inadvertent, accidental, or malicious intents. It is thoroughly updated with new chapters and the latest coverage of topics not tackled in any previous books such as target organ toxicity, radiation and radioactive materials, FDA regulatory issues, and ethics in veterinary toxicology. There are also expanded discussions on international topics such as epidemiology of animal poisonings and regulatory guidelines and poisonous plants in Europe. Problem solving strategies are offered for treatment. This volume will be of interest to practitioners, professors and students of veterinary medicine and veterinary toxicology, poison control centers, marine biologists, environmentalists and animal scientists. - Selected for inclusion in Doody's Core Titles 2013, an essential collection development tool for health sciences libraries - New chapters covering important and timely topics such as melamine and cyanuric acid, toxicogenomics, toxic gases and veterinary medical geology - Expanded look at international topics, such as epidemiology of animal poisonings, regulatory guidelines and poisonous plants in Europe - Heavily contributed book with chapters written by qualified and well-experienced authorities across all areas of veterinary toxicology - Problem solving strategies are offered for treatment as well as in-depth knowledge of the basic mechanisms of veterinary toxicology

Download or read book Nonparametric Methods in Statistics and Related Topics written by Madan Lal Puri and published by Walter de Gruyter. This book was released on 2013-02-06 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professor Puri is one of the most versatile and prolific researchers in the world in mathematical statistics. His research areas include nonparametric statistics, order statistics, limit theory under mixing, time series, splines, tests of normality, generalized inverses of matrices and related topics, stochastic processes, statistics of directional data, random sets, and fuzzy sets and fuzzy measures. His fundamental contributions in developing new rank-based methods and precise evaluation of the standard procedures, asymptotic expansions of distributions of rank statistics, as well as large deviation results concerning them, span such areas as analysis of variance, analysis of covariance, multivariate analysis, and time series, to mention a few. His in-depth analysis has resulted in pioneering research contributions to prominent journals that have substantial impact on current research. This book together with the other two volumes (Volume 2: Probability Theory and Extreme Value Theory; Volume 3: Time Series, Fuzzy Analysis and Miscellaneous Topics), are a concerted effort to make his research works easily available to the research community. The sheer volume of the research output by him and his collaborators, coupled with the broad spectrum of the subject matters investigated, and the great number of outlets where the papers were published, attach special significance in making these works easily accessible. The papers selected for inclusion in this work have been classified into three volumes each consisting of several parts. All three volumes carry a final part consisting of the contents of the other two, as well as the complete list of Professor Puri's publications.

Download or read book SAS for Linear Models written by Ramon Littell and published by John Wiley & Sons. This book was released on 2002-05-24 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Features and capabilities of the REG, ANOVA, and GLM procedures are included in this introduction to analysing linear models with the SAS System. This guide shows how to apply the appropriate procedure to data analysis problems and understand PROC GLM output. Other helpful guidelines and discussions cover the following significant areas: Multivariate linear models; lack-of-fit analysis; covariance and heterogeneity of slopes; a classification with both crossed and nested effects; and analysis of variance for balanced data. This fourth edition includes updated examples, new software-related features, and new material, including a chapter on generalised linear models. Version 8 of the SAS System was used to run the SAS code examples in the book. * Provides clear explanations of how to use SAS to analyse linear models * Includes numerous SAS outputs * Includes new chapter on generalised linear models * Uses version 8 of the SAS system This book assists data analysts who use SAS/STAT software to analyse data using regression analysis and analysis of variance. It assumes familiarity with basic SAS concepts such as creating SAS data sets with the DATA step and manipulating SAS data sets with the procedures in base SAS software.

Download or read book Jekel s Epidemiology Biostatistics and Preventive Medicine E Book written by Joann G. Elmore and published by Elsevier Health Sciences. This book was released on 2020-01-15 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by renowned epidemiologists and public health experts, this unique text provides complete, concise coverage of epidemiology, biostatistics, preventive medicine, and public health in clear, easy-to-understand terms. One convenient volume delivers must-know content in four complex areas—information that's sure to be covered in today's classrooms and on USMLE exams—presented with a clinical focus and real-life medical examples throughout. Depth of coverage, concise writing style, outstanding online review questions, a clinical emphasis ... these features and more make Jekel's your go-to resource for learning, study, and review. - Focuses on clinical problem solving and decision making using epidemiologic concepts and examples. - Contains more clinical cases throughout, including global examples. - Offers expanded coverage of the impact of big data and precision medicine, as well as an updated and reorganized biostatistics section. - Features quick-reference boxes that showcase key concepts and calculations, and dynamic illustrations that facilitate learning using a highly visual approach. - Provides almost 300 multiple-choice chapter review questions and answers in print, with additional questions and more online at Student Consult. - Aligns content to board blueprints for the USMLE as well as the three specialties certified by the American Board of Preventive Medicine: Occupational Medicine, and Public Health & General Preventive Medicine—and is recommended by the ABPM as a top review source for its core specialty examination. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all the text, figures, and references from the book on a variety of devices. - Evolve Instructor site, with an image and table bank as well as chapter overviews as PowerPoints, is available to instructors through their Elsevier sales rep or via request at: https://evolve.elsevier.com.

Download or read book Encyclopedia of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 2434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Download or read book UCSF General Catalog written by University of California, San Francisco and published by . This book was released on 1992 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: