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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 Statistical Tests in Medical Research

Download or read book Statistical Tests in Medical Research written by Jaykaran and published by JAYPEE BROTHERS PUBLISHERS. This book was released on 2011 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Statistical Methods in Medical Research

Download or read book Statistical Methods in Medical Research written by Charan Singh Rayat and published by Springer. This book was released on 2018-08-23 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers all aspects of statistical methods in detail with applications. It presents solutions to the needs of post-graduate medical students, doctors and basic medical scientists for statistical evaluation of data. In present era, dependency on softwares for statistical analysis is eroding the basic understanding of the statistical methods and their applications. As a result, there are very few basic medical scientists capable of analyzing their research data due to lack of knowledge and ability. This book has been written in systematic way supported by figures and tables for basic understanding of various terms, definitions, formulae and applications of statistical methods with solved examples and graphic presentation of data to create interest in this mathematical science.

Book Essential Statistical Methods for Medical Statistics

Download or read book Essential Statistical Methods for Medical Statistics written by J. Philip Miller and published by Elsevier. This book was released on 2010-11-08 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essential Statistical Methods for Medical Statistics presents only key contributions which have been selected from the volume in the Handbook of Statistics: Medical Statistics, Volume 27 (2009). While the use of statistics in these fields has a long and rich history, the explosive growth of science in general, and of clinical and epidemiological sciences in particular, has led to the development of new methods and innovative adaptations of standard methods. This volume is appropriately focused for individuals working in these fields. Contributors are internationally renowned experts in their respective areas. - Contributors are internationally renowned experts in their respective areas - Addresses emerging statistical challenges in epidemiological, biomedical, and pharmaceutical research - Methods for assessing Biomarkers, analysis of competing risks - Clinical trials including sequential and group sequential, crossover designs, cluster randomized, and adaptive designs - Structural equations modelling and longitudinal data analysis

Book Practical Statistics for Medical Research

Download or read book Practical Statistics for Medical Research written by Douglas G. Altman and published by CRC Press. This book was released on 1990-11-22 with total page 630 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most medical researchers, whether clinical or non-clinical, receive some background in statistics as undergraduates. However, it is most often brief, a long time ago, and largely forgotten by the time it is needed. Furthermore, many introductory texts fall short of adequately explaining the underlying concepts of statistics, and often are divorced from the reality of conducting and assessing medical research. Practical Statistics for Medical Research is a problem-based text for medical researchers, medical students, and others in the medical arena who need to use statistics but have no specialized mathematics background. The author draws on twenty years of experience as a consulting medical statistician to provide clear explanations to key statistical concepts, with a firm emphasis on practical aspects of designing and analyzing medical research. The text gives special attention to the presentation and interpretation of results and the many real problems that arise in medical research.

Book The Statistical Evaluation of Medical Tests for Classification and Prediction

Download or read book The Statistical Evaluation of Medical Tests for Classification and Prediction written by Margaret Sullivan Pepe and published by OUP Oxford. This book was released on 2003-03-13 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes statistical techniques for the design and evaluation of research studies on medical diagnostic tests, screening tests, biomarkers and new technologies for classification and prediction in medicine.

Book Statistics in Medicine

Download or read book Statistics in Medicine written by Robert H. Riffenburgh and published by Academic Press. This book was released on 2006 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicine deals with treatments that work often but not always, so treatment success must be based on probability. Statistical methods lift medical research from the anecdotal to measured levels of probability. This book presents the common statistical methods used in 90% of medical research, along with the underlying basics, in two parts: a textbook section for use by students in health care training programs, e.g., medical schools or residency training, and a reference section for use by practicing clinicians in reading medical literature and performing their own research. The book does not require a significant level of mathematical knowledge and couches the methods in multiple examples drawn from clinical medicine, giving it applicable context. Easy-to-follow format incorporates medical examples, step-by-step methods, and check yourself exercises Two-part design features course material and a professional reference section Chapter summaries provide a review of formulas, method algorithms, and check lists Companion site links to statistical databases that can be downloaded and used to perform the exercises from the book and practice statistical methods New in this Edition: New chapters on: multifactor tests on means of continuous data, equivalence testing, and advanced methods New topics include: trial randomization, treatment ethics in medical research, imputation of missing data, and making evidence-based medical decisions Updated database coverage and additional exercises Expanded coverage of numbers needed to treat and to benefit, and regression analysis including stepwise regression and Cox regression Thorough discussion on required sample size

Book Statistical Methods in Medical Research

Download or read book Statistical Methods in Medical Research written by Peter Armitage and published by John Wiley & Sons. This book was released on 2013-07-01 with total page 664 pages. Available in PDF, EPUB and Kindle. Book excerpt: The explanation and implementation of statistical methods for the medical researcher or statistician remains an integral part of modern medical research. This book explains the use of experimental and analytical biostatistics systems. Its accessible style allows it to be used by the non-mathematician as a fundamental component of successful research. Since the third edition, there have been many developments in statistical techniques. The fourth edition provides the medical statistician with an accessible guide to these techniques and to reflect the extent of their usage in medical research. The new edition takes a much more comprehensive approach to its subject. There has been a radical reorganization of the text to improve the continuity and cohesion of the presentation and to extend the scope by covering many new ideas now being introduced into the analysis of medical research data. The authors have tried to maintain the modest level of mathematical exposition that characterized the earlier editions, essentially confining the mathematics to the statement of algebraic formulae rather than pursuing mathematical proofs. Received the Highly Commended Certificate in the Public Health Category of the 2002 BMA Books Competition.

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 Medical Uses of Statistics

Download or read book Medical Uses of Statistics written by Bailar/Mostelle and published by CRC Press. This book was released on 2019-05-20 with total page 478 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work explains the purpose of statistical methods in medical studies and analyzes the statistical techniques used by clinical investigators, with special emphasis on studies published in "The New England Journal of Medicine". It clarifies fundamental concepts of statistical design and analysis, and facilitates the understanding of research results.

Book Statistical Methods in Diagnostic Medicine

Download or read book Statistical Methods in Diagnostic Medicine written by Xiao-Hua Zhou and published by John Wiley & Sons. This book was released on 2014-08-21 with total page 597 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition " . . . the book is a valuable addition to the literature in the field, serving as a much-needed guide for both clinicians and advanced students."—Zentralblatt MATH A new edition of the cutting-edge guide to diagnostic tests in medical research In recent years, a considerable amount of research has focused on evolving methods for designing and analyzing diagnostic accuracy studies. Statistical Methods in Diagnostic Medicine, Second Edition continues to provide a comprehensive approach to the topic, guiding readers through the necessary practices for understanding these studies and generalizing the results to patient populations. Following a basic introduction to measuring test accuracy and study design, the authors successfully define various measures of diagnostic accuracy, describe strategies for designing diagnostic accuracy studies, and present key statistical methods for estimating and comparing test accuracy. Topics new to the Second Edition include: Methods for tests designed to detect and locate lesions Recommendations for covariate-adjustment Methods for estimating and comparing predictive values and sample size calculations Correcting techniques for verification and imperfect standard biases Sample size calculation for multiple reader studies when pilot data are available Updated meta-analysis methods, now incorporating random effects Three case studies thoroughly showcase some of the questions and statistical issues that arise in diagnostic medicine, with all associated data provided in detailed appendices. A related web site features Fortran, SAS®, and R software packages so that readers can conduct their own analyses. Statistical Methods in Diagnostic Medicine, Second Edition is an excellent supplement for biostatistics courses at the graduate level. It also serves as a valuable reference for clinicians and researchers working in the fields of medicine, epidemiology, and biostatistics.

Book Understanding Clinical Data Analysis

Download or read book Understanding Clinical Data Analysis written by Ton J. Cleophas and published by Springer. This book was released on 2016-08-23 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook consists of ten chapters, and is a must-read to all medical and health professionals, who already have basic knowledge of how to analyze their clinical data, but still, wonder, after having done so, why procedures were performed the way they were. The book is also a must-read to those who tend to submerge in the flood of novel statistical methodologies, as communicated in current clinical reports, and scientific meetings. In the past few years, the HOW-SO of current statistical tests has been made much more simple than it was in the past, thanks to the abundance of statistical software programs of an excellent quality. However, the WHY-SO may have been somewhat under-emphasized. For example, why do statistical tests constantly use unfamiliar terms, like probability distributions, hypothesis testing, randomness, normality, scientific rigor, and why are Gaussian curves so hard, and do they make non-mathematicians getting lost all the time? The book will cover the WHY-SOs.

Book Statistics Applied to Clinical Trials

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.

Book An Introduction to Medical Statistics

Download or read book An Introduction to Medical Statistics written by Martin Bland and published by Oxford University Press. This book was released on 2015-07-23 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its Fourth Edition, An Introduction to Medical Statistics continues to be a 'must-have' textbook for anyone who needs a clear logical guide to the subject. Written in an easy-to-understand style and packed with real life examples, the text clearly explains the statistical principles used in the medical literature. Taking readers through the common statistical methods seen in published research and guidelines, the text focuses on how to interpret and analyse statistics for clinical practice. Using extracts from real studies, the author illustrates how data can be employed correctly and incorrectly in medical research helping readers to evaluate the statistics they encounter and appropriately implement findings in clinical practice. End of chapter exercises, case studies and multiple choice questions help readers to apply their learning and develop their own interpretative skills. This thoroughly revised edition includes new chapters on meta-analysis, missing data, and survival analysis.

Book Statistical Thinking in Clinical Trials

Download or read book Statistical Thinking in Clinical Trials written by Michael A. Proschan and published by CRC Press. This book was released on 2021-11-24 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and randomization-based inference is the cornerstone of this book. Read this book to learn the elegance and simplicity of re-randomization tests as the basis for statistical inference (the analyze as you randomize principle) and see how re-randomization tests can save a trial that required an unplanned, mid-course design change. Other principles enable the reader to quickly and confidently check calculations without relying on computer programs. The `EZ’ principle says that a single sample size formula can be applied to a multitude of statistical tests. The `O minus E except after V’ principle provides a simple estimator of the log odds ratio that is ideally suited for stratified analysis with a binary outcome. The same principle can be used to estimate the log hazard ratio and facilitate stratified analysis in a survival setting. Learn these and other simple techniques that will make you an invaluable clinical trial statistician.

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 A Practical Approach to Using Statistics in Health Research

Download or read book A Practical Approach to Using Statistics in Health Research written by Adam Mackridge and published by John Wiley & Sons. This book was released on 2018-05-08 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: A hands-on guide to using statistics in health research, from planning, through analysis, and on to reporting A Practical Approach to Using Statistics in Health Research offers an easy to use, step-by-step guide for using statistics in health research. The authors use their experience of statistics and health research to explain how statistics fit in to all stages of the research process. They explain how to determine necessary sample sizes, interpret whether there are statistically significant difference in outcomes between groups, and use measured effect sizes to decide whether any changes are large enough to be relevant to professional practice. The text walks you through how to identify the main outcome measure for your study and the factor which you think may influence that outcome and then determine what type of data will be used to record both of these. It then describes how this information is used to select the most appropriate methods to report and analyze your data. A step-by-step guide on how to use a range of common statistical procedures are then presented in separate chapters. To help you make sure that you are using statistics robustly, the authors also explore topics such as multiple testing and how to check whether measured data follows a normal distribution. Videos showing how to use computer packages to carry out all the various methods mentioned in the book are available on our companion web site. This book: • Covers statistical aspects of all the stages of health research from planning to final reporting • Explains how to report statistical planning, how analyses were performed, and the results and conclusion • Puts the spotlight on consideration of clinical significance and not just statistical significance • Explains the importance of reporting 95% confidence intervals for effect size • Includes a systematic guide for selection of statistical tests and uses example data sets and videos to help you understand exactly how to use statistics Written as an introductory guide to statistics for healthcare professionals, students and lecturers in the fields of pharmacy, nursing, medicine, dentistry, physiotherapy, and occupational therapy, A Practical Approach to Using Statistics in Health Research:From Planning to Reporting is a handy reference that focuses on the application of statistical methods within the health research context.