Evidence Synthesis And Meta Analysis For Drug Safety

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Evidence Synthesis and Meta-analysis for Drug Safety

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : World Health Organization
ISBN 13 : 9789290360858
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis Evidence Synthesis and Meta-analysis for Drug Safety by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book Evidence Synthesis and Meta-analysis for Drug Safety written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development program and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. There is increasing demand by decision-makers in health care, the bio-pharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy will take an overview of all the evidence and where it is possible and sensible, combine the evidence and summarize the results. For efficacy, the outcomes generally use the same or very similar predefined events for each of the trials to be included. Most regulatory guidance and many Cochrane Collaboration reviews have usually given more attention to assessment of benefits, while issues around combining evidence on harms have not been as well-covered. However, the (inevitably) unplanned nature of the data on safety makes the process more difficult. Combining evidence on adverse events (AEs), where these were not the focus of the original studies, is more challenging than combining evidence on pre-specified benefits. This focus on AEs represents the main contribution of the current CIOMS X report. The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. Although some of the content of this report describes highly technical statistical concepts and methods (in particular Chapter 4), the ambition of the working group has been to make it comprehensible to non-statisticians for its use in clinical epidemiology and regulatory science. To that end, Chapters 3 and 4, which contain the main technical statistical aspects of the appropriate design, analysis and reporting of a meta-analysis of safety data are followed by Chapter 5 with a thought process for evaluating the findings of a meta-analysis and how to communicate these.

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309218160
Total Pages : 292 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Ethical and Scientific Issues in Studying the Safety of Approved Drugs by : Institute of Medicine

Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-07-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.

Finding What Works in Health Care

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309164257
Total Pages : 267 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Finding What Works in Health Care by : Institute of Medicine

Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Cochrane Handbook for Systematic Reviews of Interventions

Author : Julian P. T. Higgins
Publisher : Wiley
ISBN 13 : 9780470699515
Total Pages : 672 pages
Book Rating : 4.6/5 (995 download)

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Book Synopsis Cochrane Handbook for Systematic Reviews of Interventions by : Julian P. T. Higgins

Download or read book Cochrane Handbook for Systematic Reviews of Interventions written by Julian P. T. Higgins and published by Wiley. This book was released on 2008-11-24 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.

Systematic Reviews in Health Care

Author : Matthias Egger
Publisher : John Wiley & Sons
ISBN 13 : 0470693142
Total Pages : 512 pages
Book Rating : 4.4/5 (76 download)

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Book Synopsis Systematic Reviews in Health Care by : Matthias Egger

Download or read book Systematic Reviews in Health Care written by Matthias Egger and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this best-selling book has been thoroughly revised and expanded to reflect the significant changes and advances made in systematic reviewing. New features include discussion on the rationale, meta-analyses of prognostic and diagnostic studies and software, and the use of systematic reviews in practice.

Evidence Synthesis for Decision Making in Healthcare

Author : Nicky J. Welton
Publisher : John Wiley & Sons
ISBN 13 : 111830540X
Total Pages : 296 pages
Book Rating : 4.1/5 (183 download)

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Book Synopsis Evidence Synthesis for Decision Making in Healthcare by : Nicky J. Welton

Download or read book Evidence Synthesis for Decision Making in Healthcare written by Nicky J. Welton and published by John Wiley & Sons. This book was released on 2012-04-12 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the evaluation of healthcare, rigorous methods of quantitative assessment are necessary to establish interventions that are both effective and cost-effective. Usually a single study will not fully address these issues and it is desirable to synthesize evidence from multiple sources. This book aims to provide a practical guide to evidence synthesis for the purpose of decision making, starting with a simple single parameter model, where all studies estimate the same quantity (pairwise meta-analysis) and progressing to more complex multi-parameter structures (including meta-regression, mixed treatment comparisons, Markov models of disease progression, and epidemiology models). A comprehensive, coherent framework is adopted and estimated using Bayesian methods. Key features: A coherent approach to evidence synthesis from multiple sources. Focus is given to Bayesian methods for evidence synthesis that can be integrated within cost-effectiveness analyses in a probabilistic framework using Markov Chain Monte Carlo simulation. Provides methods to statistically combine evidence from a range of evidence structures. Emphasizes the importance of model critique and checking for evidence consistency. Presents numerous worked examples, exercises and solutions drawn from a variety of medical disciplines throughout the book. WinBUGS code is provided for all examples. Evidence Synthesis for Decision Making in Healthcare is intended for health economists, decision modelers, statisticians and others involved in evidence synthesis, health technology assessment, and economic evaluation of health technologies.

Umbrella Reviews

Author : Giuseppe Biondi-Zoccai
Publisher : Springer
ISBN 13 : 3319256556
Total Pages : 391 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Umbrella Reviews by : Giuseppe Biondi-Zoccai

Download or read book Umbrella Reviews written by Giuseppe Biondi-Zoccai and published by Springer. This book was released on 2016-02-03 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is an ideal guide to umbrella reviews, overviews of reviews, and meta-epidemiologic studies for evidence synthesis. Research is conducted at different levels: primary research consists of original studies while secondary research comprises qualitative reviews, systematic reviews, and meta-analyses. Recently, a novel further level of research has been introduced, based on the analysis and pooling of reviews and meta-analysis. This book is the first to focus solely on this new type of research design, which permits a comprehensive and powerful synthesis of scientific evidence in medicine as well as in many other fields in order to inform decision-making. All aspects are covered, including review design and registration, the searching, abstracting, appraisal, and synthesis of evidence, the appraisal of moderators and confounders, and state of the art reporting. Case studies in a range of medical specialties are then presented. The hands-on approach of the book, written by a multinational team of experts, will enable the reader to interpret and independently conduct umbrella reviews.

Sharing Clinical Trial Data

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 304 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Effective Care of the Newborn Infant

Author : John C. Sinclair
Publisher :
ISBN 13 :
Total Pages : 714 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Effective Care of the Newborn Infant by : John C. Sinclair

Download or read book Effective Care of the Newborn Infant written by John C. Sinclair and published by . This book was released on 1992 with total page 714 pages. Available in PDF, EPUB and Kindle. Book excerpt: This companion volume to the highly acclaimed Effective Care in Pregnancy and Childbirth (OUP 1989, edited by Iain Chalmers et al.) evaluates the care of newborn infants. Medical research has produced an explosion of new knowledge concerning the causes, diagnosis, prognosis, treatment and prevention of diseases of the newborn infant. As the pace of therapeutic innovation quickens, there is an increasing need for efficient access to information concerning the probable effects of therapy. This book meets the urgent demand for a systematic summary of the best available evidence concerning the expected outcomes of therapeutic decisions in neonatology. This revolutionary work consists fundamentally of quantitative reviews of randomized trials of alternative courses of action. It contains some 2000 new analyses of data from the clinical trials literature, representing the vast majority of randomized trials in neonatology. The result is the first systematic review of evidence from randomized clinical trials in this field and an explicit dissection of the research data supporting, or in some cases not supporting, clinical management of the newborn. This book will interest pediatricians, especially neonatologists; obstetricians, especially maternal-fetal medicine specialists; family practitioners; and epidemiologists.

Quantitative Drug Safety and Benefit Risk Evaluation

Author : William Wang
Publisher : CRC Press
ISBN 13 : 0429950004
Total Pages : 402 pages
Book Rating : 4.4/5 (299 download)

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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 402 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.

Textbook of Pharmacoepidemiology

Author : Brian L. Strom
Publisher : John Wiley & Sons
ISBN 13 : 1118708008
Total Pages : 756 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Textbook of Pharmacoepidemiology by : Brian L. Strom

Download or read book Textbook of Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2013-05-13 with total page 756 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies Designed for students with basic knowledge of epidemiology and public health Includes many case studies to illustrate pharmacoepidemiology in real clinical setting

Presenting Medical Statistics from Proposal to Publication

Author : Janet L. Peacock
Publisher : Oxford University Press
ISBN 13 : 0192526731
Total Pages : 224 pages
Book Rating : 4.1/5 (925 download)

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Book Synopsis Presenting Medical Statistics from Proposal to Publication by : Janet L. Peacock

Download or read book Presenting Medical Statistics from Proposal to Publication written by Janet L. Peacock and published by Oxford University Press. This book was released on 2017-07-21 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: As many medical and healthcare researchers have a love-hate relationship with statistics, the second edition of this practical reference book may make all the difference. Using practical examples, mainly from the authors' own research, the book explains how to make sense of statistics, turn statistical computer output into coherent information, and help decide which pieces of information to report and how to present them. The book takes you through all the stages of the research process, from the initial research proposal, through ethical approval and data analysis, to reporting on and publishing the findings. Helpful tips and information boxes, offer clear guidance throughout, including easily followed instructions on how to: -develop a quantitative research proposal for ethical/institutional approval or research funding -write up the statistical aspects of a paper for publication -choose and perform simple and more advanced statistical analyses -describe the statistical methods and present the results of an analysis. This new edition covers a wider range of statistical programs - SAS, STATA, R, and SPSS, and shows the commands needed to obtain the analyses and how to present it, whichever program you are using. Each specific example is annotated to indicate other scenarios that can be analysed using the same methods, allowing you to easily transpose the knowledge gained from the book to your own research. The principles of good presentation are also covered in detail, from translating relevant results into suitable extracts, through to randomised controlled trials, and how to present a meta-analysis. An added ingredient is the inclusion of code and datasets for all analyses shown in the book on our website (http://medical-statistics.info). Written by three experienced biostatisticians based in the UK and US, this is a step-by-step guide that will be invaluable to researchers and postgraduate students in medicine, those working in the professions allied to medicine, and statisticians in consultancy roles.

Medical Uses of Statistics

Author : John C. Bailar III
Publisher : CRC Press
ISBN 13 : 0429529600
Total Pages : 490 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Medical Uses of Statistics by : John C. Bailar III

Download or read book Medical Uses of Statistics written by John C. Bailar III and published by CRC Press. This book was released on 2019-05-20 with total page 490 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.

Drug-Induced Liver Injury

Author :
Publisher : Academic Press
ISBN 13 : 0128173173
Total Pages : 288 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Drug-Induced Liver Injury by :

Download or read book Drug-Induced Liver Injury written by and published by Academic Press. This book was released on 2019-07-13 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. Includes the authority and expertise of leading contributors in pharmacology Presents the latest release in the Advances in Pharmacology series

Real-World Evidence in Drug Development and Evaluation

Author : Harry Yang
Publisher : CRC Press
ISBN 13 : 0429676824
Total Pages : 191 pages
Book Rating : 4.4/5 (296 download)

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Book Synopsis Real-World Evidence in Drug Development and Evaluation by : Harry Yang

Download or read book Real-World Evidence in Drug Development and Evaluation written by Harry Yang and published by CRC Press. This book was released on 2021-01-11 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise

Biopharmaceutical Applied Statistics Symposium

Author : Karl E. Peace
Publisher : Springer
ISBN 13 : 9811078262
Total Pages : 245 pages
Book Rating : 4.8/5 (11 download)

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Book Synopsis Biopharmaceutical Applied Statistics Symposium by : Karl E. Peace

Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by Springer. This book was released on 2018-08-21 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the second of the 3-volume book series. The topics covered include: Statistical Approaches to the Meta-analysis of Randomized Clinical Trials, Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies, Generalized Tests in Clinical Trials, Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free , Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia, Selected Statistical Issues in Patient-reported Outcomes, Network Meta-analysis, Detecting Safety Signals Among Adverse Events in Clinical Trials, Applied Meta-analysis Using R, Treatment of Missing Data in Comparative Effectiveness Research, Causal Estimands: A Common Language for Missing Data, Bayesian Subgroup Analysis with Examples, Statistical Methods in Diagnostic Devices, A Question-Based Approach to the Analysis of Safety Data, Analysis of Two-stage Adaptive Seamless Trial Design, and Multiplicity Problems in Clinical Trials – A Regulatory Perspective.

Clinical Epidemiology

Author : Patrick S. Parfrey
Publisher : Humana
ISBN 13 : 9781493955770
Total Pages : 0 pages
Book Rating : 4.9/5 (557 download)

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Book Synopsis Clinical Epidemiology by : Patrick S. Parfrey

Download or read book Clinical Epidemiology written by Patrick S. Parfrey and published by Humana. This book was released on 2016-10-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on improving the diagnosis, prognosis, and management of human disease, this book takes on the issues of research design, measurement, and evaluation which are critical to clinical epidemiology. This second edition of Clinical Epidemiology: Practice and Methods opens with how best to frame a clinical research question, the ethics associated with doing a research project in humans, and the definition of various biases that occur in clinical research. From there, it continues by examining issues of design, measurement, and analysis associated with various research designs, including determination of risk in longitudinal studies, assessment of therapy in randomized controlled clinical trials, and evaluation of diagnostic tests, and then delves into the more specialized area of clinical genetic research, before concluding with basic methods used in evidence-based decision making including critical appraisal, aggregation of multiple studies using meta-analysis, health technology assessment, clinical practice guidelines, development of health policy, translational research, how to utilize administrative databases, and knowledge translation. Written for the highly successful Methods in Molecular Biology series, chapters include the kind of detail and practical advice to ensure real world success. Comprehensive and authoritative, Clinical Epidemiology: Practice and Methods, Second Edition is intended to educate researchers on how to undertake clinical research and should be helpful not only to medical practitioners but also to basic scientists who want to extend their work to humans, to allied health professionals interested in scientific evaluation, and to trainees in clinical epidemiology.