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Book Small Clinical Trials

    Book Details:
  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release : 2001-01-01
  • ISBN : 0309171148
  • Pages : 221 pages

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.

Book Quantitative and Statistical Research Methods

Download or read book Quantitative and Statistical Research Methods written by William E. Martin and published by John Wiley & Sons. This book was released on 2012-07-09 with total page 498 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quantitative and Statistical Research Methods This user-friendly textbook teaches students to understand and apply procedural steps in completing quantitative studies. It explains statistics while progressing through the steps of the hypothesis-testing process from hypothesis to results. The research problems used in the book reflect statistical applications related to interesting and important topics. In addition, the book provides a Research Analysis and Interpretation Guide to help students analyze research articles. Designed as a hands-on resource, each chapter covers a single research problem and offers directions for implementing the research method from start to finish. Readers will learn how to: Pinpoint research questions and hypotheses Identify, classify, and operationally define the study variables Choose appropriate research designs Conduct power analysis Select an appropriate statistic for the problem Use a data set Conduct data screening and analyses using SPSS Interpret the statistics Write the results related to the problem Quantitative and Statistical Research Methods allows students to immediately, independently, and successfully apply quantitative methods to their own research projects.

Book The Analysis of Case control Studies

Download or read book The Analysis of Case control Studies written by Norman E. Breslow and published by . This book was released on 1980 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Introduction to Statistical Methods for Clinical Trials

Download or read book Introduction to Statistical Methods for Clinical Trials written by Thomas D. Cook and published by CRC Press. This book was released on 2007-11-19 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Book Study Design and Statistical Analysis

Download or read book Study Design and Statistical Analysis written by Mitchell Katz and published by Cambridge University Press. This book was released on 2006-06-22 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book takes the reader through the entire research process: choosing a question, designing a study, collecting the data, using univariate, bivariate and multivariable analysis, and publishing the results. It does so by using plain language rather than complex derivations and mathematical formulae. It focuses on the nuts and bolts of performing research by asking and answering the most basic questions about doing research studies. Making good use of numerous tables, graphs and tips, this book helps to demystify the process. A generous number of up-to-date examples from the clinical literature give an illustrated and practical account of how to use multivariable analysis.

Book Strategy and Statistics in Clinical Trials

Download or read book Strategy and Statistics in Clinical Trials written by Joseph Tal and published by Academic Press. This book was released on 2011-07-14 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Delineates the statistical building blocks and concepts of clinical trials.

Book Statistical Design for Research

Download or read book Statistical Design for Research written by Leslie Kish and published by John Wiley & Sons. This book was released on 2005-02-25 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Wiley Classics Library consists of selected books that have become recognized classics in their respective fields. With these new unabridged and inexpensive editions, Wiley hopes to extend the life of these important works by making them available to future generations of mathematicians and scientists. This title addresses those basic aspects of research design which are common to many related fields in the social sciences, health sciences, education, and market research. The work presents a unified approach to a common core of problems of statistical design that exists in all these fields, along with basic similarities in practical solutions. Describing many examples and analogies that are 'portable' from application field to application field, Statistical Design for Research deals with designs that are the primary basis of research studies, but are neglected in most statistical textbooks that tend to concentrate on statistical analysis. This text takes a broader, more general and philosophical view of the statistics for the more fundamental aspects of design than do the standard treatments of experimental design. Extensively illustrated and carefully organized into seven chapters and 44 sections, this book can be readily consulted by research workers or graduate students!

Book Communication Research Statistics

Download or read book Communication Research Statistics written by John C. Reinard and published by SAGE Publications. This book was released on 2006-04-20 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: "While most books on statistics seem to be written as though targeting other statistics professors, John Reinard′s Communication Research Statistics is especially impressive because it is clearly intended for the student reader, filled with unusually clear explanations and with illustrations on the use of SPSS. I enjoyed reading this lucid, student-friendly book and expect students will benefit enormously from its content and presentation. Well done!" --John C. Pollock, The College of New Jersey Written in an accessible style using straightforward and direct language, Communication Research Statistics guides students through the statistics actually used in most empirical research undertaken in communication studies. This introductory textbook is the only work in communication that includes details on statistical analysis of data with a full set of data analysis instructions based on SPSS 12 and Excel XP. Key Features: Emphasizes basic and introductory statistical thinking: The basic needs of novice researchers and students are addressed, while underscoring the foundational elements of statistical analyses in research. Students learn how statistics are used to provide evidence for research arguments and how to evaluate such evidence for themselves. Prepares students to use statistics: Students are encouraged to use statistics as they encounter and evaluate quantitative research. The book details how statistics can be understood by developing actual skills to carry out rudimentary work. Examples are drawn from mass communication, speech communication, and communication disorders. Incorporates SPSS 12 and Excel: A distinguishing feature is the inclusion of coverage of data analysis by use of SPSS 12 and by Excel. Information on the use of major computer software is designed to let students use such tools immediately. Companion Web Site! A dedicated Web site includes a glossary, data sets, chapter summaries, additional readings, links to other useful sites, selected "calculators" for computation of related statistics, additional macros for selected statistics using Excel and SPSS, and extra chapters on multiple discriminant analysis and loglinear analysis. Intended Audience: Ideal for undergraduate and graduate courses in Communication Research Statistics or Methods; also relevant for many Research Methods courses across the social sciences

Book Statistical Methods

    Book Details:
  • Author : Rudolf J. Freund
  • Publisher : Elsevier
  • Release : 2003-01-07
  • ISBN : 0080498221
  • Pages : 694 pages

Download or read book Statistical Methods written by Rudolf J. Freund and published by Elsevier. This book was released on 2003-01-07 with total page 694 pages. Available in PDF, EPUB and Kindle. Book excerpt: This broad text provides a complete overview of most standard statistical methods, including multiple regression, analysis of variance, experimental design, and sampling techniques. Assuming a background of only two years of high school algebra, this book teaches intelligent data analysis and covers the principles of good data collection. * Provides a complete discussion of analysis of data including estimation, diagnostics, and remedial actions * Examples contain graphical illustration for ease of interpretation * Intended for use with almost any statistical software * Examples are worked to a logical conclusion, including interpretation of results * A complete Instructor's Manual is available to adopters

Book Statistical Analysis of Ecotoxicity Studies

Download or read book Statistical Analysis of Ecotoxicity Studies written by John W. Green and published by John Wiley & Sons. This book was released on 2018-08-14 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the issues relevant to the design, analysis, and interpretation of toxicity studies that examine chemicals for use in the environment Statistical Analysis of Ecotoxicity Studies offers a guide to the design, analysis, and interpretation of a range of experiments that are used to assess the toxicity of chemicals. While the book highlights ecotoxicity studies, the methods presented are applicable to the broad range of toxicity studies. The text contains myriad datasets (from laboratory and field research) that clearly illustrate the book's topics. The datasets reveal the techniques, pitfalls, and precautions derived from these studies. The text includes information on recently developed methods for the analysis of severity scores and other ordered responses, as well as extensive power studies of competing tests and computer simulation studies of regression models that offer an understanding of the sensitivity (or lack thereof) of various methods and the quality of parameter estimates from regression models. The authors also discuss the regulatory process indicating how test guidelines are developed and review the statistical methodology in current or pending OECD and USEPA ecotoxicity guidelines. This important guide: Offers the information needed for the design and analysis to a wide array of ecotoxicity experiments and to the development of international test guidelines used to assess the toxicity of chemicals Contains a thorough examination of the statistical issues that arise in toxicity studies, especially ecotoxicity Includes an introduction to toxicity experiments and statistical analysis basics Includes programs in R and excel Covers the analysis of continuous and Quantal data, analysis of data as well as Regulatory Issues Presents additional topics (Mesocosm and Microplate experiments, mixtures of chemicals, benchmark dose models, and limit tests) as well as software Written for directors, scientists, regulators, and technicians, Statistical Analysis of Ecotoxicity Studies provides a sound understanding of the technical and practical issues in designing, analyzing, and interpreting toxicity studies to support or challenge chemicals for use in the environment.

Book Common Statistical Methods for Clinical Research with SAS Examples  Third Edition

Download or read book Common Statistical Methods for Clinical Research with SAS Examples Third Edition written by Glenn Walker and published by SAS Institute. This book was released on 2010-02-15 with total page 553 pages. Available in PDF, EPUB and Kindle. Book excerpt: Glenn Walker and Jack Shostak's Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is a thoroughly updated edition of the popular introductory statistics book for clinical researchers. This new edition has been extensively updated to include the use of ODS graphics in numerous examples as well as a new emphasis on PROC MIXED. Straightforward and easy to use as either a text or a reference, the book is full of practical examples from clinical research to illustrate both statistical and SAS methodology. Each example is worked out completely, step by step, from the raw data. Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is an applications book with minimal theory. Each section begins with an overview helpful to nonstatisticians and then drills down into details that will be valuable to statistical analysts and programmers. Further details, as well as bonus information and a guide to further reading, are presented in the extensive appendices. This text is a one-source guide for statisticians that documents the use of the tests used most often in clinical research, with assumptions, details, and some tricks--all in one place. This book is part of the SAS Press program.

Book An Introduction to Statistical Analysis in Research

Download or read book An Introduction to Statistical Analysis in Research written by Kathleen F. Weaver and published by John Wiley & Sons. This book was released on 2017-09-05 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides well-organized coverage of statistical analysis and applications in biology, kinesiology, and physical anthropology with comprehensive insights into the techniques and interpretations of R, SPSS®, Excel®, and Numbers® output An Introduction to Statistical Analysis in Research: With Applications in the Biological and Life Sciences develops a conceptual foundation in statistical analysis while providing readers with opportunities to practice these skills via research-based data sets in biology, kinesiology, and physical anthropology. Readers are provided with a detailed introduction and orientation to statistical analysis as well as practical examples to ensure a thorough understanding of the concepts and methodology. In addition, the book addresses not just the statistical concepts researchers should be familiar with, but also demonstrates their relevance to real-world research questions and how to perform them using easily available software packages including R, SPSS®, Excel®, and Numbers®. Specific emphasis is on the practical application of statistics in the biological and life sciences, while enhancing reader skills in identifying the research questions and testable hypotheses, determining the appropriate experimental methodology and statistical analyses, processing data, and reporting the research outcomes. In addition, this book: • Aims to develop readers’ skills including how to report research outcomes, determine the appropriate experimental methodology and statistical analysis, and identify the needed research questions and testable hypotheses • Includes pedagogical elements throughout that enhance the overall learning experience including case studies and tutorials, all in an effort to gain full comprehension of designing an experiment, considering biases and uncontrolled variables, analyzing data, and applying the appropriate statistical application with valid justification • Fills the gap between theoretically driven, mathematically heavy texts and introductory, step-by-step type books while preparing readers with the programming skills needed to carry out basic statistical tests, build support figures, and interpret the results • Provides a companion website that features related R, SPSS, Excel, and Numbers data sets, sample PowerPoint® lecture slides, end of the chapter review questions, software video tutorials that highlight basic statistical concepts, and a student workbook and instructor manual An Introduction to Statistical Analysis in Research: With Applications in the Biological and Life Sciences is an ideal textbook for upper-undergraduate and graduate-level courses in research methods, biostatistics, statistics, biology, kinesiology, sports science and medicine, health and physical education, medicine, and nutrition. The book is also appropriate as a reference for researchers and professionals in the fields of anthropology, sports research, sports science, and physical education. KATHLEEN F. WEAVER, PhD, is Associate Dean of Learning, Innovation, and Teaching and Professor in the Department of Biology at the University of La Verne. The author of numerous journal articles, she received her PhD in Ecology and Evolutionary Biology from the University of Colorado. VANESSA C. MORALES, BS, is Assistant Director of the Academic Success Center at the University of La Verne. SARAH L. DUNN, PhD, is Associate Professor in the Department of Kinesiology at the University of La Verne and is Director of Research and Sponsored Programs. She has authored numerous journal articles and received her PhD in Health and Exercise Science from the University of New South Wales. KANYA GODDE, PhD, is Assistant Professor in the Department of Anthropology and is Director/Chair of Institutional Review Board at the University of La Verne. The author of numerous journal articles and a member of the American Statistical Association, she received her PhD in Anthropology from the University of Tennessee. PABLO F. WEAVER, PhD, is Instructor in the Department of Biology at the University of La Verne. The author of numerous journal articles, he received his PhD in Ecology and Evolutionary Biology from the University of Colorado.

Book Handbook of Statistical Methods for Case Control Studies

Download or read book Handbook of Statistical Methods for Case Control Studies written by Ørnulf Borgan and published by CRC Press. This book was released on 2018-06-27 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Statistical Methods for Case-Control Studies is written by leading researchers in the field. It provides an in-depth treatment of up-to-date and currently developing statistical methods for the design and analysis of case-control studies, as well as a review of classical principles and methods. The handbook is designed to serve as a reference text for biostatisticians and quantitatively-oriented epidemiologists who are working on the design and analysis of case-control studies or on related statistical methods research. Though not specifically intended as a textbook, it may also be used as a backup reference text for graduate level courses. Book Sections Classical designs and causal inference, measurement error, power, and small-sample inference Designs that use full-cohort information Time-to-event data Genetic epidemiology About the Editors Ørnulf Borgan is Professor of Statistics, University of Oslo. His book with Andersen, Gill and Keiding on counting processes in survival analysis is a world classic. Norman E. Breslow was, at the time of his death, Professor Emeritus in Biostatistics, University of Washington. For decades, his book with Nick Day has been the authoritative text on case-control methodology. Nilanjan Chatterjee is Bloomberg Distinguished Professor, Johns Hopkins University. He leads a broad research program in statistical methods for modern large scale biomedical studies. Mitchell H. Gail is a Senior Investigator at the National Cancer Institute. His research includes modeling absolute risk of disease, intervention trials, and statistical methods for epidemiology. Alastair Scott was, at the time of his death, Professor Emeritus of Statistics, University of Auckland. He was a major contributor to using survey sampling methods for analyzing case-control data. Chris J. Wild is Professor of Statistics, University of Auckland. His research includes nonlinear regression and methods for fitting models to response-selective data.

Book Controversial Statistical Issues in Clinical Trials

Download or read book Controversial Statistical Issues in Clinical Trials written by Shein-Chung Chow and published by CRC Press. This book was released on 2016-04-19 with total page 598 pages. Available in PDF, EPUB and Kindle. Book excerpt: In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials cov

Book Statistical Design  Monitoring  and Analysis of Clinical Trials

Download or read book Statistical Design Monitoring and Analysis of Clinical Trials written by Weichung Joe Shih and published by CRC Press. This book was released on 2021-10-26 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. 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, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book's balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Book Design of Experiments and Advanced Statistical Techniques in Clinical Research

Download or read book Design of Experiments and Advanced Statistical Techniques in Clinical Research written by Basavarajaiah D. M. and published by Springer Nature. This book was released on 2020-11-05 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent Statistical techniques are one of the basal evidence for clinical research, a pivotal in handling new clinical research and in evaluating and applying prior research. This book explores various choices of statistical tools and mechanisms, analyses of the associations among different clinical attributes. It uses advanced statistical methods to describe real clinical data sets, when the clinical processes being examined are still in the process. This book also discusses distinct methods for building predictive and probability distribution models in clinical situations and ways to assess the stability of these models and other quantitative conclusions drawn by realistic experimental data sets. Design of experiments and recent posthoc tests have been used in comparing treatment effects and precision of the experimentation. This book also facilitates clinicians towards understanding statistics and enabling them to follow and evaluate the real empirical studies (formulation of randomized control trial) that pledge insight evidence base for clinical practices. This book will be a useful resource for clinicians, postgraduates scholars in medicines, clinical research beginners and academicians to nurture high-level statistical tools with extensive scope.

Book Statistical Strategies for Small Sample Research

Download or read book Statistical Strategies for Small Sample Research written by Rick H. Hoyle and published by SAGE Publications. This book was released on 1999-03-30 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: Newer statistical models, such as structural equation modeling and hierarchical linear modeling, require large sample sizes inappropriate for many research questions or unrealistic for many research arenas. How can researchers get the sophistication and flexibility of large sample studies without the requirement of prohibitively large samples? This book describes and illustrates statistical strategies that meet the sophistication/flexibility criteria for analyzing data from small samples of fewer than 150 cases. Contributions from some of the leading researchers in the field cover the use of multiple imputation software and how it can be used profitably with small data sets and missing data; ways to increase statistical power when sample size cannot be increased; and strategies for computing effect sizes and combining effect sizes across studies. Other contributions describe how to hypothesis test using the bootstrap; methods for pooling effect size indicators from single-case studies; frameworks for drawing inferences from cross-tabulated data; how to determine whether a correlation or covariance matrix warrants structure analysis; and what conditions indicate latent variable modeling is a viable approach to correct for unreliability in the mediator. Other topics include the use of dynamic factor analysis to model temporal processes by analyzing multivariate; time-series data from small numbers of individuals; techniques for coping with estimation problems in confirmatory factor analysis in small samples; how the state space model can be used with surprising accuracy with small data samples; and the use of partial least squares as a viable alternative to covariance-based SEM when the N is small and/or the number of variables in a model is large.