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Detailed Study Design
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Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2011-10-25 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. - Provides extensive coverage of the "study schema" and related features of study design - Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design - Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design - Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials - Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe - For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn
Book Synopsis Research Design by : John W. Creswell
Download or read book Research Design written by John W. Creswell and published by SAGE. This book was released on 2014 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: The bestseller that pioneered the comparison of qualitative, quantitative, and mixed methods research design continues in its Fourth Edition to help students and researchers prepare their plan or proposal for a scholarly journal article, dissertation or thesis.
Book Synopsis Case Study Research by : John Gerring
Download or read book Case Study Research written by John Gerring and published by Cambridge University Press. This book was released on 2016-12-24 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Case Study Research: Principles and Practices provides a general understanding of the case study method as well as specific tools for its successful implementation. These tools are applicable in a variety of fields including anthropology, business and management, communications, economics, education, medicine, political science, psychology, social work, and sociology. Topics include: a survey of case study approaches; a methodologically tractable definition of 'case study'; strategies for case selection, including random sampling and other algorithmic approaches; quantitative and qualitative modes of case study analysis; and problems of internal and external validity. The second edition of this core textbook is designed to be accessible to readers who are new to the subject and is thoroughly revised and updated, incorporating recent research, numerous up-to-date studies and comprehensive lecture slides.
Book Synopsis Designing Clinical Research by : Stephen B. Hulley
Download or read book Designing Clinical Research written by Stephen B. Hulley and published by Lippincott Williams & Wilkins. This book was released on 2011-11-30 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.
Author :Agency for Health Care Research and Quality (U.S.) Publisher :Government Printing Office ISBN 13 :1587634236 Total Pages :236 pages Book Rating :4.5/5 (876 download)
Book Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)
Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :385 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Book Synopsis Research Design & Method Selection by : Diana Panke
Download or read book Research Design & Method Selection written by Diana Panke and published by SAGE. This book was released on 2018-09-10 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: Heavily grounded in helping students make the best choices for their projects, this book explores how to develop and work with theory, research questions, and method selection to build solid, logical proposals and move from research concepts to fully realized designs. Rather than rushing initial planning stages or reverse engineering questions from preferred methods, it encourages students to challenge unconscious biases around method selection and analysis and provides step-by-step guidance on choosing a method that is in-line with the question being explored. Focused on the role of the researcher within research design, it stresses the need to consider the theoretical underpinnings of research and not just practical issues when designing a project. It provides a sophisticated toolkit to understand: - The critical issues associated with both qualitative and quantitative methods - The approach that works best for specific research questions - How design choices can affect practice. Perfect for upper undergraduate and postgraduate students, this book will instil confidence and good decision making to ensure constructively informed design and practice.
Book Synopsis The National Children's Study Research Plan by : National Research Council
Download or read book The National Children's Study Research Plan written by National Research Council and published by National Academies Press. This book was released on 2008-08-16 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Children's Study (NCS) is planned to be the largest long-term study of environmental and genetic effects on children's health ever conducted in the United States. It proposes to examine the effects of environmental influences on the health and development of approximately 100,000 children across the United States, following them from before birth until age 21. By archiving all of the data collected, the NCS is intended to provide a valuable resource for analyses conducted many years into the future. This book evaluates the research plan for the NCS, by assessing the scientific rigor of the study and the extent to which it is being carried out with methods, measures, and collection of data and specimens to maximize the scientific yield of the study. The book concludes that if the NCS is conducted as proposed, the database derived from the study should be valuable for investigating hypotheses described in the research plan as well as additional hypotheses that will evolve. Nevertheless, there are important weaknesses and shortcomings in the research plan that diminish the study's expected value below what it might be.
Book Synopsis Study Design and Statistical Analysis by : Mitchell Katz
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 Synopsis The Cambridge Handbook of Computing Education Research by : Sally A. Fincher
Download or read book The Cambridge Handbook of Computing Education Research written by Sally A. Fincher and published by . This book was released on 2019-02-13 with total page 924 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an authoritative introduction to Computing Education research written by over 50 leading researchers from academia and the industry.
Book Synopsis Planning Clinical Research by : Robert A. Parker
Download or read book Planning Clinical Research written by Robert A. Parker and published by Cambridge University Press. This book was released on 2016-10-12 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: Planning clinical research requires many decisions. The authors of this book explain key decisions with examples showing what works and what does not.
Download or read book Epidemiology written by Mark Woodward and published by CRC Press. This book was released on 2013-12-19 with total page 844 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highly praised for its broad, practical coverage, the second edition of this popular text incorporated the major statistical models and issues relevant to epidemiological studies. Epidemiology: Study Design and Data Analysis, Third Edition continues to focus on the quantitative aspects of epidemiological research. Updated and expanded, this edition shows students how statistical principles and techniques can help solve epidemiological problems. New to the Third Edition New chapter on risk scores and clinical decision rules New chapter on computer-intensive methods, including the bootstrap, permutation tests, and missing value imputation New sections on binomial regression models, competing risk, information criteria, propensity scoring, and splines Many more exercises and examples using both Stata and SAS More than 60 new figures After introducing study design and reviewing all the standard methods, this self-contained book takes students through analytical methods for both general and specific epidemiological study designs, including cohort, case-control, and intervention studies. In addition to classical methods, it now covers modern methods that exploit the enormous power of contemporary computers. The book also addresses the problem of determining the appropriate size for a study, discusses statistical modeling in epidemiology, covers methods for comparing and summarizing the evidence from several studies, and explains how to use statistical models in risk forecasting and assessing new biomarkers. The author illustrates the techniques with numerous real-world examples and interprets results in a practical way. He also includes an extensive list of references for further reading along with exercises to reinforce understanding. Web Resource A wealth of supporting material can be downloaded from the book’s CRC Press web page, including: Real-life data sets used in the text SAS and Stata programs used for examples in the text SAS and Stata programs for special techniques covered Sample size spreadsheet
Download or read book Clinical Trials written by Duolao Wang and published by Remedica. This book was released on 2006 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.
Book Synopsis Understanding and Evaluating Research by : Sue L. T. McGregor
Download or read book Understanding and Evaluating Research written by Sue L. T. McGregor and published by SAGE Publications. This book was released on 2017-10-25 with total page 880 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding and Evaluating Research: A Critical Guide shows students how to be critical consumers of research and to appreciate the power of methodology as it shapes the research question, the use of theory in the study, the methods used, and how the outcomes are reported. The book starts with what it means to be a critical and uncritical reader of research, followed by a detailed chapter on methodology, and then proceeds to a discussion of each component of a research article as it is informed by the methodology. The book encourages readers to select an article from their discipline, learning along the way how to assess each component of the article and come to a judgment of its rigor or quality as a scholarly report.
Book Synopsis Research Design by : John W. Creswell
Download or read book Research Design written by John W. Creswell and published by SAGE Publications. This book was released on 2017-12-12 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: This best-selling text pioneered the comparison of qualitative, quantitative, and mixed methods research design. For all three approaches, John W. Creswell and new co-author J. David Creswell include a preliminary consideration of philosophical assumptions, key elements of the research process, a review of the literature, an assessment of the use of theory in research applications, and reflections about the importance of writing and ethics in scholarly inquiry. The Fifth Edition includes more coverage of: epistemological and ontological positioning in relation to the research question and chosen methodology; case study, PAR, visual and online methods in qualitative research; qualitative and quantitative data analysis software; and in quantitative methods more on power analysis to determine sample size, and more coverage of experimental and survey designs; and updated with the latest thinking and research in mixed methods.
Book Synopsis Frugal Innovation by : Yasser Bhatti
Download or read book Frugal Innovation written by Yasser Bhatti and published by Cambridge University Press. This book was released on 2018-11-15 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: In light of growing discourse on 'frugal innovation', this book offers novel approaches to innovation based on extensive empirical research. The study complements a decade of scholarly attention on frugal innovation by taking a research-based approach to innovation in resource-scarce and complex institutional contexts. The findings suggest that concepts such as frugal, reverse, jugaad, social, grassroots and inclusive innovation in fact represent heterogeneous assemblies of innovation for social, environmental and economic value. The conceptual framework invites attention to more plural sources and elements in the study of models of innovation to inspire further research in the fields of strategy, innovation, entrepreneurship, economic sociology and development studies. The design framework offers models, metrics and competencies for practitioners and policymakers to identify, evaluate and design frugal innovations. The comprehensive view of frugal innovation demonstrates how firms can implement globally competitive strategies by pursuing innovation for humanity to improve lives for everyone, everywhere.
