Download or read book Statistical Methods for Immunogenicity Assessment written by Harry Yang and published by CRC Press. This book was released on 2015-07-17 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation stra

Download or read book Statistics in Clinical Vaccine Trials written by Jozef Nauta and published by Springer Science & Business Media. This book was released on 2010-10-07 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: This monograph offers well-founded training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. The book's scope is practical rather than theoretical. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the statistical methodology. Many real-life examples and SAS codes are presented, making application of the methods straightforward. Topics discussed include maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of equivalence and non-inferiority immunogenicity trial data, analysis of data from vaccine field efficacy trials (including data from studies with recurrent infection data), fitting protection curves to data of challenge or field efficacy studies, and the analysis of vaccine safety data.

Download or read book Statistical Methods for Healthcare Performance Monitoring written by Alex Bottle and published by CRC Press. This book was released on 2016-08-05 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare is important to everyone, yet large variations in its quality have been well documented both between and within many countries. With demand and expenditure rising, it’s more crucial than ever to know how well the healthcare system and all its components – from staff member to regional network – are performing. This requires data, which inevitably differ in form and quality. It also requires statistical methods, the output of which needs to be presented so that it can be understood by whoever needs it to make decisions. Statistical Methods for Healthcare Performance Monitoring covers measuring quality, types of data, risk adjustment, defining good and bad performance, statistical monitoring, presenting the results to different audiences and evaluating the monitoring system itself. Using examples from around the world, it brings all the issues and perspectives together in a largely non-technical way for clinicians, managers and methodologists. Statistical Methods for Healthcare Performance Monitoring is aimed at statisticians and researchers who need to know how to measure and compare performance, health service regulators, health service managers with responsibilities for monitoring performance, and quality improvement scientists, including those involved in clinical audits.

Download or read book Applied Surrogate Endpoint Evaluation Methods with SAS and R written by Ariel Alonso and published by CRC Press. This book was released on 2016-11-30 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.

Download or read book Epidemiological and Statistical Methods for Rapid Health Assessment written by World Health Organization and published by . This book was released on 1991 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Statistical Design and Analysis of Clinical Trials written by Weichung Joe Shih and published by CRC Press. This book was released on 2015-07-28 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fu

Download or read book Design Analysis of Clinical Trials for Economic Evaluation Reimbursement written by Iftekhar Khan and published by CRC Press. This book was released on 2015-11-11 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Economic evaluation has become an essential component of clinical trial design to show that new treatments and technologies offer value to payers in various healthcare systems. Although many books exist that address the theoretical or practical aspects of cost-effectiveness analysis, this book differentiates itself from the competition by detailing

Download or read book Statistical Testing Strategies in the Health Sciences written by Albert Vexler and published by CRC Press. This book was released on 2017-12-19 with total page 668 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Testing Strategies in the Health Sciences provides a compendium of statistical approaches for decision making, ranging from graphical methods and classical procedures through computationally intensive bootstrap strategies to advanced empirical likelihood techniques. It bridges the gap between theoretical statistical methods and practical procedures applied to the planning and analysis of health-related experiments. The book is organized primarily based on the type of questions to be answered by inference procedures or according to the general type of mathematical derivation. It establishes the theoretical framework for each method, with a substantial amount of chapter notes included for additional reference. It then focuses on the practical application for each concept, providing real-world examples that can be easily implemented using corresponding statistical software code in R and SAS. The book also explains the basic elements and methods for constructing correct and powerful statistical decision-making processes to be adapted for complex statistical applications. With techniques spanning robust statistical methods to more computationally intensive approaches, this book shows how to apply correct and efficient testing mechanisms to various problems encountered in medical and epidemiological studies, including clinical trials. Theoretical statisticians, medical researchers, and other practitioners in epidemiology and clinical research will appreciate the book’s novel theoretical and applied results. The book is also suitable for graduate students in biostatistics, epidemiology, health-related sciences, and areas pertaining to formal decision-making mechanisms.

Download or read book Statistical Topics in Health Economics and Outcomes Research written by Demissie Alemayehu, PhD and published by CRC Press. This book was released on 2017-11-22 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the allocation of resources. Accordingly, it is now customary for health technology assessment and reimbursement agencies to request for HEOR evidence, in addition to data from clinical trials, to inform decisions about patient access to new treatment options. While there is a great deal of literature on HEOR, there is a need for a volume that presents a coherent and unified review of the major issues that arise in application, especially from a statistical perspective. Statistical Topics in Health Economics and Outcomes Research fulfils that need by presenting an overview of the key analytical issues and best practice. Special attention is paid to key assumptions and other salient features of statistical methods customarily used in the area, and appropriate and relatively comprehensive references are made to emerging trends. The content of the book is purposefully designed to be accessible to readers with basic quantitative backgrounds, while providing an in-depth coverage of relatively complex statistical issues. The book will make a very useful reference for researchers in the pharmaceutical industry, academia, and research institutions involved with HEOR studies. The targeted readers may include statisticians, data scientists, epidemiologists, outcomes researchers, health economists, and healthcare policy and decision-makers.

Download or read book Statistics in Clinical and Observational Vaccine Studies written by Jozef Nauta and published by Springer Nature. This book was released on 2020-03-14 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers an overview of the statistical methods used in clinical and observational vaccine studies. Pursuing a practical rather than theoretical approach, it presents a range of real-world examples with SAS codes, making the application of the methods straightforward. This revised edition has been significantly expanded to reflect the current interest in this area. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the analysis of immunogenicity data. Discussed are, amongst others, maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of data of equivalence, and non-inferiority immunogenicity studies. Other topics covered include fitting protection curves to data from vaccine efficacy studies, and the analysis of vaccine safety data. In addition, the book features four new chapters on vaccine field studies: an introductory one, one on randomized vaccine efficacy studies, one on observational vaccine effectiveness studies, and one on the meta-analysis of vaccine efficacy studies. The book offers useful insights for statisticians and epidemiologists working in the pharmaceutical industry or at vaccines institutes, as well as graduate students interested in pharmaceutical statistics.

Download or read book Bioequivalence and Statistics in Clinical Pharmacology written by Scott D. Patterson and published by CRC Press. This book was released on 2017-03-27 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

Download or read book Quantitative Methods for HIV AIDS Research written by Cliburn Chan and published by CRC Press. This book was released on 2017-08-07 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quantitative Methods in HIV/AIDS Research provides a comprehensive discussion of modern statistical approaches for the analysis of HIV/AIDS data. The first section focuses on statistical issues in clinical trials and epidemiology that are unique to or particularly challenging in HIV/AIDS research; the second section focuses on the analysis of laboratory data used for immune monitoring, biomarker discovery and vaccine development; the final section focuses on statistical issues in the mathematical modeling of HIV/AIDS pathogenesis, treatment and epidemiology. This book brings together a broad perspective of new quantitative methods in HIV/AIDS research, contributed by statisticians and mathematicians immersed in HIV research, many of whom are current or previous leaders of CFAR quantitative cores. It is the editors’ hope that the work will inspire more statisticians, mathematicians and computer scientists to collaborate and contribute to the interdisciplinary challenges of understanding and addressing the AIDS pandemic.

Download or read book Clinical Trial Data Analysis Using R and SAS written by Ding-Geng (Din) Chen and published by CRC Press. This book was released on 2017-06-01 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."—Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.

Download or read book Bayesian Methods for Repeated Measures written by Lyle D. Broemeling and published by CRC Press. This book was released on 2015-08-04 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analyze Repeated Measures Studies Using Bayesian TechniquesGoing beyond standard non-Bayesian books, Bayesian Methods for Repeated Measures presents the main ideas for the analysis of repeated measures and associated designs from a Bayesian viewpoint. It describes many inferential methods for analyzing repeated measures in various scientific areas,

Download or read book Quantitative Methods for Traditional Chinese Medicine Development written by Shein-Chung Chow and published by CRC Press. This book was released on 2015-10-15 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Quantitative Methods for Traditional Chinese Medicine Development is the first book entirely devoted to the design and analysis of TCM development from a Western perspective, i.e., evidence-based clinical research and development. The book provides not only a comprehensive summary of innovative quantitative methods for developing TCMs but also a useful desk reference for principal investigators involved in personalized medicine. Written by one of the world's most prominent biostatistics researchers, the book connects the pharmaceutical industry, regulatory agencies, and academia. It presents a state-of-the-art examination of the subject for: Scientists and researchers who are engaged in pharmaceutical/clinical research and development of TCMs Those in regulatory agencies who make decisions in the review and approval process of TCM regulatory submissions Biostatisticians who provide statistical support to assess clinical safety and effectiveness of TCMs and related issues regarding quality control and assurance as well as to test for consistency in the manufacturing processes for TCMs This book covers all of the statistical issues encountered at various stages of pharmaceutical/clinical development of a TCM. It explains regulatory requirements; product specifications and standards; and various statistical techniques for evaluation of TCMs, validation of diagnostic procedures, and testing consistency

Download or read book Methods in Comparative Effectiveness Research written by Constantine Gatsonis and published by CRC Press. This book was released on 2017-02-24 with total page 547 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that will aid patients, clinicians, purchasers, and health policy makers in making informed decisions at both the individual and population levels. CER encompasses a very broad range of types of studies—experimental, observational, prospective, retrospective, and research synthesis. This volume covers the main areas of quantitative methodology for the design and analysis of CER studies. The volume has four major sections—causal inference; clinical trials; research synthesis; and specialized topics. The audience includes CER methodologists, quantitative-trained researchers interested in CER, and graduate students in statistics, epidemiology, and health services and outcomes research. The book assumes a masters-level course in regression analysis and familiarity with clinical research.

Download or read book Applied Biclustering Methods for Big and High Dimensional Data Using R written by Adetayo Kasim and published by CRC Press. This book was released on 2016-08-18 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proven Methods for Big Data Analysis As big data has become standard in many application areas, challenges have arisen related to methodology and software development, including how to discover meaningful patterns in the vast amounts of data. Addressing these problems, Applied Biclustering Methods for Big and High-Dimensional Data Using R shows how to apply biclustering methods to find local patterns in a big data matrix. The book presents an overview of data analysis using biclustering methods from a practical point of view. Real case studies in drug discovery, genetics, marketing research, biology, toxicity, and sports illustrate the use of several biclustering methods. References to technical details of the methods are provided for readers who wish to investigate the full theoretical background. All the methods are accompanied with R examples that show how to conduct the analyses. The examples, software, and other materials are available on a supplementary website.