Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions About Medicinal Products

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Author :
Publisher : Frontiers Media SA
ISBN 13 : 2889760685
Total Pages : 156 pages
Book Rating : 4.8/5 (897 download)

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Book Synopsis Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions About Medicinal Products by : Kenneth K. C. Lee

Download or read book Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions About Medicinal Products written by Kenneth K. C. Lee and published by Frontiers Media SA. This book was released on 2022-05-03 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions about Medicinal Products, volume II

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Author :
Publisher : Frontiers Media SA
ISBN 13 : 2832548555
Total Pages : 112 pages
Book Rating : 4.8/5 (325 download)

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Book Synopsis Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions about Medicinal Products, volume II by : Kenneth K. C. Lee

Download or read book Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions about Medicinal Products, volume II written by Kenneth K. C. Lee and published by Frontiers Media SA. This book was released on 2024-05-09 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of this proposed Research Topic is to encourage researchers in this field from different jurisdictions to use this as a platform to share their experiences in conducting studies designed in a patient-centric approach using RWD, their encountered areas of concern during the process, and the anticipated impact of their studies.

Beyond the HIPAA Privacy Rule

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Publisher : National Academies Press
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Examining the Impact of Real-World Evidence on Medical Product Development

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Author :
Publisher : National Academies Press
ISBN 13 : 030948829X
Total Pages : 231 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Examining the Impact of Real-World Evidence on Medical Product Development by : National Academies of Sciences, Engineering, and Medicine

Download or read book Examining the Impact of Real-World Evidence on Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-05-05 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.

Registries for Evaluating Patient Outcomes

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Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.5/5 (876 download)

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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 396 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.

Evidence-Based Medicine and the Changing Nature of Health Care

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Author :
Publisher : National Academies Press
ISBN 13 : 0309113695
Total Pages : 202 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Evidence-Based Medicine and the Changing Nature of Health Care by : Institute of Medicine

Download or read book Evidence-Based Medicine and the Changing Nature of Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2008-09-06 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.

Real-World Evidence Generation and Evaluation of Therapeutics

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Author :
Publisher : National Academies Press
ISBN 13 : 0309455626
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Real-World Evidence Generation and Evaluation of Therapeutics by : National Academies of Sciences, Engineering, and Medicine

Download or read book Real-World Evidence Generation and Evaluation of Therapeutics written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-08-05 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.

Real-World Evidence in Drug Development and Evaluation

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Author :
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

The Fourth Industrial Revolution

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Author :
Publisher : Currency
ISBN 13 : 1524758876
Total Pages : 192 pages
Book Rating : 4.5/5 (247 download)

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Book Synopsis The Fourth Industrial Revolution by : Klaus Schwab

Download or read book The Fourth Industrial Revolution written by Klaus Schwab and published by Currency. This book was released on 2017-01-03 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: World-renowned economist Klaus Schwab, Founder and Executive Chairman of the World Economic Forum, explains that we have an opportunity to shape the fourth industrial revolu­tion, which will fundamentally alter how we live and work. Schwab argues that this revolution is different in scale, scope and complexity from any that have come before. Characterized by a range of new technologies that are fusing the physical, digital and biological worlds, the developments are affecting all disciplines, economies, industries and governments, and even challenging ideas about what it means to be human. Artificial intelligence is already all around us, from supercomputers, drones and virtual assistants to 3D printing, DNA sequencing, smart thermostats, wear­able sensors and microchips smaller than a grain of sand. But this is just the beginning: nanomaterials 200 times stronger than steel and a million times thinner than a strand of hair and the first transplant of a 3D printed liver are already in development. Imagine “smart factories” in which global systems of manu­facturing are coordinated virtually, or implantable mobile phones made of biosynthetic materials. The fourth industrial revolution, says Schwab, is more significant, and its ramifications more profound, than in any prior period of human history. He outlines the key technologies driving this revolution and discusses the major impacts expected on government, business, civil society and individu­als. Schwab also offers bold ideas on how to harness these changes and shape a better future—one in which technology empowers people rather than replaces them; progress serves society rather than disrupts it; and in which innovators respect moral and ethical boundaries rather than cross them. We all have the opportunity to contribute to developing new frame­works that advance progress.

Sharing Clinical Trial Data

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Author :
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.

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

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Author :
Publisher : Government Printing Office
ISBN 13 : 1587634236
Total Pages : 204 pages
Book Rating : 4.5/5 (876 download)

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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 204 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)

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

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Author :
Publisher : WIPO
ISBN 13 : 9280523082
Total Pages : 259 pages
Book Rating : 4.2/5 (85 download)

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Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization

Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

Making Data Talk

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Publisher : Oxford University Press, USA
ISBN 13 : 019538153X
Total Pages : 340 pages
Book Rating : 4.1/5 (953 download)

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Book Synopsis Making Data Talk by : David E. Nelson (M.D.)

Download or read book Making Data Talk written by David E. Nelson (M.D.) and published by Oxford University Press, USA. This book was released on 2009 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authors summarize and synthesize research on the selection and presentation of data pertinent to public health and provide practical suggestions, based on this research summary and synthesis, on how scientists and other public health practitioners can better communicate data to the public, policy makers and the press.

Modern Methods of Clinical Investigation

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Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Finding What Works in Health Care

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Author :
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.

Health in the 21st Century

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Publisher :
ISBN 13 : 9789264355514
Total Pages : 210 pages
Book Rating : 4.3/5 (555 download)

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Book Synopsis Health in the 21st Century by :

Download or read book Health in the 21st Century written by and published by . This book was released on 2019 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report explores how data and digital technology can help achieve policy objectives and drive positive transformation in the health sector while managing new risks such as privacy, equity and implementation costs. It examines the following topics: improving service delivery models; empowering people to take an active role in their health and their care; improving public health; managing biomedical technologies; enabling better collaboration across borders; and improving health system governance and stewardship. It also examines how health workforces should be equipped to make the most of digital technology. The report contains findings from surveys of OECD countries and shares a range of examples that illustrate the potential benefits as well as challenges of the digital transformation in the health sector. Findings and recommendations are relevant for policymakers, health care providers, payers, industry as well as patients, citizens and civil society.

Disease Control Priorities in Developing Countries

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Author :
Publisher : World Bank Publications
ISBN 13 : 0821361805
Total Pages : 1449 pages
Book Rating : 4.8/5 (213 download)

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Book Synopsis Disease Control Priorities in Developing Countries by : Dean T. Jamison

Download or read book Disease Control Priorities in Developing Countries written by Dean T. Jamison and published by World Bank Publications. This book was released on 2006-04-02 with total page 1449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on careful analysis of burden of disease and the costs ofinterventions, this second edition of 'Disease Control Priorities in Developing Countries, 2nd edition' highlights achievable priorities; measures progresstoward providing efficient, equitable care; promotes cost-effectiveinterventions to targeted populations; and encourages integrated effortsto optimize health. Nearly 500 experts - scientists, epidemiologists, health economists,academicians, and public health practitioners - from around the worldcontributed to the data sources and methodologies, and identifiedchallenges and priorities, resulting in this integrated, comprehensivereference volume on the state of health in developing countries.