Confidence Intervals For Discrete Data In Clinical Research

Download Confidence Intervals For Discrete Data In Clinical Research full books in PDF, epub, and Kindle. Read online Confidence Intervals For Discrete Data In Clinical Research ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!

Confidence Intervals for Discrete Data in Clinical Research

Author : Vivek Pradhan
Publisher : CRC Press
ISBN 13 : 1351690175
Total Pages : 240 pages
Book Rating : 4.3/5 (516 download)

DOWNLOAD NOW!

Book Synopsis Confidence Intervals for Discrete Data in Clinical Research by : Vivek Pradhan

Download or read book Confidence Intervals for Discrete Data in Clinical Research written by Vivek Pradhan and published by CRC Press. This book was released on 2021-11-15 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Confidence Intervals for Discrete Data in Clinical Research is designed as a toolbox for biomedical researchers. Analysis of discrete data is one of the most used yet vexing areas in clinical research. The array of methodologies available in the literature to address the inferential questions for binomial and multinomial data can be a double-edged sword. On the one hand, these methods open a rich avenue of exploration of data; on the other, the wide-ranging and competing methodologies potentially lead to conflicting inferences, adding to researchers' confusion and frustration and also leading to reporting bias. This book addresses the problems that many practitioners experience in choosing and implementing fit for purpose data analysis methods to answer critical inferential questions for binomial and count data. The book is an outgrowth of the authors' collective experience in biomedical research and provides an excellent overview of inferential questions of interest for binomial proportions and rates based on count data, and reviews various solutions to these problems available in the literature. Each chapter discusses the strengths and weaknesses of the methods and suggests practical recommendations. The book's primary focus is on applications in clinical research, and the goal is to provide direct benefit to the users involved in the biomedical field.

Confidence Intervals for Discrete Data in Clinical Research

Author : Ashis Gangopadhyay
Publisher :
ISBN 13 : 9781032128634
Total Pages : 0 pages
Book Rating : 4.1/5 (286 download)

DOWNLOAD NOW!

Book Synopsis Confidence Intervals for Discrete Data in Clinical Research by : Ashis Gangopadhyay

Download or read book Confidence Intervals for Discrete Data in Clinical Research written by Ashis Gangopadhyay and published by . This book was released on 2024-01-29 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is only one published book on confidence interval for clinical research. This book has a cookbook style with several examples and codes so that methods presented in the book can be implemented. The primary audience will be statisticians.

Statistical Thinking in Clinical Trials

Author : Michael A. Proschan
Publisher : CRC Press
ISBN 13 : 1351673114
Total Pages : 270 pages
Book Rating : 4.3/5 (516 download)

DOWNLOAD NOW!

Book Synopsis Statistical Thinking in Clinical Trials by : Michael A. Proschan

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 270 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.

Statistics with Confidence

Author : Douglas Altman
Publisher : John Wiley & Sons
ISBN 13 : 1118702506
Total Pages : 322 pages
Book Rating : 4.1/5 (187 download)

DOWNLOAD NOW!

Book Synopsis Statistics with Confidence by : Douglas Altman

Download or read book Statistics with Confidence written by Douglas Altman and published by John Wiley & Sons. This book was released on 2013-06-03 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This highly popular introduction to confidence intervals has been thoroughly updated and expanded. It includes methods for using confidence intervals, with illustrative worked examples and extensive guidelines and checklists to help the novice.

Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials

Author : Andrew P. Grieve
Publisher : CRC Press
ISBN 13 : 1000590232
Total Pages : 193 pages
Book Rating : 4.0/5 (5 download)

DOWNLOAD NOW!

Book Synopsis Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials by : Andrew P. Grieve

Download or read book Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials written by Andrew P. Grieve and published by CRC Press. This book was released on 2022-06-19 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials provides a practical introduction to unconditional approaches to planning randomised clinical trials, particularly aimed at drug development in the pharmaceutical industry. This book is aimed at providing guidance to practitioners in using average power, assurance and related concepts. This book brings together recent research and sets them in a consistent framework and provides a fresh insight into how such methods can be used. Features: A focus on normal theory linking average power, expected power, predictive power, assurance, conditional Bayesian power and Bayesian power. Extensions of the concepts to binomial, and time-to-event outcomes and non-inferiority trials An investigation into the upper bound on average power, assurance and Bayesian power based on the prior probability of a positive treatment effect Application of assurance to a series of trials in a development program and an introduction of the assurance of an individual trial conditional on the positive outcome of an earlier trial in the program, or to the successful outcome of an interim analysis Prior distribution of power and sample size Extension of the basic approach to proof-of-concept trials with dual success criteria Investigation of the connection between conditional and predictive power at an interim analysis and power and assurance Introduction of the idea of surety in sample sizing of clinical trials based on the width of the confidence intervals for the treatment effect, and an unconditional version.

Encyclopedia of Research Design

Author : Neil J. Salkind
Publisher : SAGE
ISBN 13 : 1412961270
Total Pages : 1779 pages
Book Rating : 4.4/5 (129 download)

DOWNLOAD NOW!

Book Synopsis Encyclopedia of Research Design by : Neil J. Salkind

Download or read book Encyclopedia of Research Design written by Neil J. Salkind and published by SAGE. This book was released on 2010-06-22 with total page 1779 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Comprising more than 500 entries, the Encyclopedia of Research Design explains how to make decisions about research design, undertake research projects in an ethical manner, interpret and draw valid inferences from data, and evaluate experiment design strategies and results. Two additional features carry this encyclopedia far above other works in the field: bibliographic entries devoted to significant articles in the history of research design and reviews of contemporary tools, such as software and statistical procedures, used to analyze results. It covers the spectrum of research design strategies, from material presented in introductory classes to topics necessary in graduate research; it addresses cross- and multidisciplinary research needs, with many examples drawn from the social and behavioral sciences, neurosciences, and biomedical and life sciences; it provides summaries of advantages and disadvantages of often-used strategies; and it uses hundreds of sample tables, figures, and equations based on real-life cases."--Publisher's description.

Medical Statistics for Cancer Studies

Author : Trevor F. Cox
Publisher : CRC Press
ISBN 13 : 1000601102
Total Pages : 334 pages
Book Rating : 4.0/5 (6 download)

DOWNLOAD NOW!

Book Synopsis Medical Statistics for Cancer Studies by : Trevor F. Cox

Download or read book Medical Statistics for Cancer Studies written by Trevor F. Cox and published by CRC Press. This book was released on 2022-06-23 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer is a dreaded disease. One in two people will be diagnosed with cancer within their lifetime. Medical Statistics for Cancer Studies shows how cancer data can be analysed in a variety of ways, covering cancer clinical trial data, epidemiological data, biological data, and genetic data. It gives some background in cancer biology and genetics, followed by detailed overviews of survival analysis, clinical trials, regression analysis, epidemiology, meta-analysis, biomarkers, and cancer informatics. It includes lots of examples using real data from the author’s many years of experience working in a cancer clinical trials unit. Features: A broad and accessible overview of statistical methods in cancer research Necessary background in cancer biology and genetics Details of statistical methodology with minimal algebra Many examples using real data from cancer clinical trials Appendix giving statistics revision.

Advanced Statistics in Regulatory Critical Clinical Initiatives

Author : Wei Zhang
Publisher : CRC Press
ISBN 13 : 1000567990
Total Pages : 318 pages
Book Rating : 4.0/5 (5 download)

DOWNLOAD NOW!

Book Synopsis Advanced Statistics in Regulatory Critical Clinical Initiatives by : Wei Zhang

Download or read book Advanced Statistics in Regulatory Critical Clinical Initiatives written by Wei Zhang and published by CRC Press. This book was released on 2022-05-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.

Case Studies in Bayesian Methods for Biopharmaceutical CMC

Author : Paul Faya
Publisher : CRC Press
ISBN 13 : 1000824772
Total Pages : 354 pages
Book Rating : 4.0/5 (8 download)

DOWNLOAD NOW!

Book Synopsis Case Studies in Bayesian Methods for Biopharmaceutical CMC by : Paul Faya

Download or read book Case Studies in Bayesian Methods for Biopharmaceutical CMC written by Paul Faya and published by CRC Press. This book was released on 2022-12-15 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics. • First book of its kind focusing strictly on CMC Bayesian case studies • Case studies with code and output • Representation from several companies across the industry as well as academia • Authors are leading and well-known Bayesian statisticians in the CMC field • Accompanying website with code for reproducibility • Reflective of real-life industry applications/problems

Digital Therapeutics

Author : Oleksandr Sverdlov
Publisher : CRC Press
ISBN 13 : 1000799239
Total Pages : 462 pages
Book Rating : 4.0/5 (7 download)

DOWNLOAD NOW!

Book Synopsis Digital Therapeutics by : Oleksandr Sverdlov

Download or read book Digital Therapeutics written by Oleksandr Sverdlov and published by CRC Press. This book was released on 2022-12-06 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the hallmarks of the 21st century medicine is the emergence of digital therapeutics (DTx)—evidence-based, clinically validated digital technologies to prevent, diagnose, treat, and manage various diseases and medical conditions. DTx solutions have been gaining interest from patients, investors, healthcare providers, health authorities, and other stakeholders because of the potential of DTx to deliver equitable, massively scalable, personalized and transformative treatments for different unmet medical needs. Digital Therapeutics: Scientific, Statistical, Clinical, and Regulatory Aspects is an unparalleled summary of the current scientific, statistical, developmental, and regulatory aspects of DTx which is poised to become the fastest growing area of the biopharmaceutical and digital medicine product development. This edited volume intends to provide a systematic exposition to digital therapeutics through 19 peer-reviewed chapters written by subject matter experts in this emerging field. This edited volume is an invaluable resource for business leaders and researchers working in public health, healthcare, digital health, information technology, and biopharmaceutical industries. It will be also useful for regulatory scientists involved in the review of DTx products, and for faculty and students involved in an interdisciplinary research on digital health and digital medicine. Key Features: Provides the taxonomy of the concepts and a navigation tool for the field of DTx. Covers important strategic aspects of the DTx industry, thereby helping investors, developers, and regulators gain a better appreciation of the potential value of DTx. Expounds on many existing and emerging state-of-the art scientific and technological tools, as well as data privacy, ethical and regulatory considerations for DTx product development. Presents several case studies of successful development of some of the most remarkable DTx products. Provides some perspectives and forward-looking statements on the future of digital medicine.

Quantitative Drug Safety and Benefit Risk Evaluation

Author : William Wang
Publisher : CRC Press
ISBN 13 : 0429949995
Total Pages : 347 pages
Book Rating : 4.4/5 (299 download)

DOWNLOAD NOW!

Book Synopsis Quantitative Drug Safety and Benefit Risk Evaluation by : William Wang

Download or read book Quantitative Drug Safety and Benefit Risk Evaluation written by William Wang and published by CRC Press. This book was released on 2021-12-30 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.

Analysis of Clinical Trials Using SAS

Author : Alex Dmitrienko
Publisher : SAS Institute
ISBN 13 : 1635261449
Total Pages : 455 pages
Book Rating : 4.6/5 (352 download)

DOWNLOAD NOW!

Book Synopsis Analysis of Clinical Trials Using SAS by : Alex Dmitrienko

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.

Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)

DOWNLOAD NOW!

Book Synopsis Small Clinical Trials by : Institute of Medicine

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.

Exact Analysis of Discrete Data

Author : Karim F. Hirji
Publisher : CRC Press
ISBN 13 : 142003619X
Total Pages : 1066 pages
Book Rating : 4.4/5 (2 download)

DOWNLOAD NOW!

Book Synopsis Exact Analysis of Discrete Data by : Karim F. Hirji

Download or read book Exact Analysis of Discrete Data written by Karim F. Hirji and published by CRC Press. This book was released on 2005-11-18 with total page 1066 pages. Available in PDF, EPUB and Kindle. Book excerpt: Researchers in fields ranging from biology and medicine to the social sciences, law, and economics regularly encounter variables that are discrete or categorical in nature. While there is no dearth of books on the analysis and interpretation of such data, these generally focus on large sample methods. When sample sizes are not large or the data are

Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation

Author : Stephen J. Walters
Publisher : John Wiley & Sons
ISBN 13 : 9780470871911
Total Pages : 380 pages
Book Rating : 4.8/5 (719 download)

DOWNLOAD NOW!

Book Synopsis Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation by : Stephen J. Walters

Download or read book Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation written by Stephen J. Walters and published by John Wiley & Sons. This book was released on 2009-09-10 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential, up-to-date guide to the design of studies and selection of the correct QoL instruments for observational studies and clinical trials. Quality of Life (QoL) outcomes or Person/Patient Reported Outcome Measures (PROMs) are now frequently being used in randomised controlled trials (RCTs) and observational studies. This book provides a practical guide to the design, analysis and interpretation of studies that use such outcomes. QoL outcomes tend to generate data with discrete, bounded and skewed distributions. Many investigators are concerned about the appropriateness of using standard statistical methods to analyse QoL data and want guidance on what methods to use. QoL outcomes are frequently used in cross-sectional surveys and non-randomised health-care evaluations. Provides a user-friendly guide to the design and analysis of clinical trials and observational studies in relation to QoL outcomes. Discusses the problems caused by QoL outcomes and presents intervention options to help tackle them. Guides the reader step-by-step through the selection of appropriate QoLs. Features exercises and solutions and a supporting website providing downloadable data files. Illustrated throughout with examples and case studies drawn from the author’s experience, this book offers statisticians and clinicians guidance on choosing between the numerous available QoL instruments.

Foundations of Anesthesia

Author : Hugh C. Hemmings
Publisher : Elsevier Health Sciences
ISBN 13 : 0323037070
Total Pages : 919 pages
Book Rating : 4.3/5 (23 download)

DOWNLOAD NOW!

Book Synopsis Foundations of Anesthesia by : Hugh C. Hemmings

Download or read book Foundations of Anesthesia written by Hugh C. Hemmings and published by Elsevier Health Sciences. This book was released on 2006-01-01 with total page 919 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanying CD-ROM ... "allows you to download figures into PowerPoint for electronic presentations." -- p. [4] of cover.

Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Author : Harry Yang
Publisher : CRC Press
ISBN 13 : 1315354454
Total Pages : 278 pages
Book Rating : 4.3/5 (153 download)

DOWNLOAD NOW!

Book Synopsis Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing by : Harry Yang

Download or read book Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing written by Harry Yang and published by CRC Press. This book was released on 2016-11-30 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.