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Increasing Importance Of Patients Generated Real World Data For Healthcare Policy Decisions About Medicinal Products Volume Ii
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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.
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:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :030948829X Total Pages :231 pages Book Rating :4.3/5 (94 download)
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.
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.
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :396 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 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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309455650 Total Pages :103 pages Book Rating :4.3/5 (94 download)
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 2017-07-05 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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309455626 Total Pages :103 pages Book Rating :4.3/5 (94 download)
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.
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.
Book Synopsis Examining the Impact of Real-World Evidence on Medical Product Development by :
Download or read book Examining the Impact of Real-World Evidence on Medical Product Development written by and published by . This book was released on 2018 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Future of Drug Safety by : Institute of Medicine
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309670551 Total Pages :99 pages Book Rating :4.3/5 (96 download)
Book Synopsis Neuroscience Data in the Cloud by : National Academies of Sciences, Engineering, and Medicine
Download or read book Neuroscience Data in the Cloud written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-06-06 with total page 99 pages. Available in PDF, EPUB and Kindle. Book excerpt: The cloud model of data sharing has led to a vast increase in the quantity and complexity of data and expanded access to these data, which has attracted many more researchers, enabled multi-national neuroscience collaborations, and facilitated the development of many new tools. Yet, the cloud model has also produced new challenges related to data storage, organization, and protection. Merely switching the technical infrastructure from local repositories to cloud repositories is not enough to optimize data use. To explore the burgeoning use of cloud computing in neuroscience, the National Academies Forum on Neuroscience and Nervous System Disorders hosted a workshop on September 24, 2019. A broad range of stakeholders involved in cloud-based neuroscience initiatives and research explored the use of cloud technology to advance neuroscience research and shared approaches to address current barriers. This publication summarizes the presentation and discussion of the workshop.
Book Synopsis Novel methods and technologies for the evaluation of drug outcomes and policies by : Zaheer-Ud-Din Babar
Download or read book Novel methods and technologies for the evaluation of drug outcomes and policies written by Zaheer-Ud-Din Babar and published by Frontiers Media SA. This book was released on 2024-04-10 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: As a leading Open Access publisher, Frontiers is committed to empowering not only scientists, but other researchers, innovators and members of the public. As such, highlighting sustainable development and the real-world applications of Drugs Outcomes Research & Policies are a key part to the agenda of Frontiers in Pharmacology. This Research Topic aims to highlight advancements in Health Economics and Outcomes Research (HEOR) techniques, methods and tools used by the pharmaceutical industry and other non-academic bodies.
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.
Book Synopsis Women in Pharmacoepidemiology: 2021 by : Luciane Cruz Lopes
Download or read book Women in Pharmacoepidemiology: 2021 written by Luciane Cruz Lopes and published by Frontiers Media SA. This book was released on with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: We are delighted to present the inaugural Frontiers in Pharmacology 'Women in Pharmacoepidemiology” series of article collections. This Research Topic is part of the Women in Pharmacology series. Other titles in the series are: Women in Obstetric and Pediatric Pharmacology: 2021 Women in Inflammation Pharmacology: 2021 Women in Integrative and Regenerative Pharmacology: 2021 Women in Pharmacology of Anti-Cancer Drugs: 2021 Women in Pharmacology of Infectious Diseases: 2021 Women in Drug Metabolism and Transport: 2021 Women in Cardiovascular and Smooth Muscle Pharmacology: 2021 Women in Inflammation Pharmacology: 2021 Women in Pharmacogenetics and Pharmacogenomics: 2021 Women in Neuropharmacology: 2021 Women in Drugs Outcomes Research and Policies: 2021 Women in Pharmacology of Ion Channels and Channelopathies: 2021 At present, according to UNESCO, less than 30% of researchers worldwide are women. Long-standing biases and gender stereotypes are discouraging girls and women away from science-related fields, and STEM research in particular. Science and gender equality are, however, essential to ensure sustainable development as highlighted by UNESCO. In order to change traditional mindsets, gender equality must be promoted, stereotypes defeated, and girls and women should be encouraged to pursue STEM careers. Therefore, Frontiers in Pharmacology is proud to offer this platform to promote the work of women scientists at different stages in their career, all over the world, and across all fields of Pharmacology. The work presented here highlights the diversity of research performed across the entire breadth of Pharmacoepidemiology research and presents advances in theory, experiment, and methodology with applications to compelling problems. For this Topic, we will be welcoming manuscripts covering: • Post-marketing observational studies on medications • Post-marketing studies in populations routinely excluded from clinical trials such as children, pregnant women, and elderlies • Observational studies on First Nations, racialized groups, and immigrant populations • Real-world evidence using large population-based administrative or clinical databases • Pharmacoepidemiologic real world evidence methodology • Novel pharmacoepidemiologic methodology such as artificial intelligence and deep learning models • Pharmacoeconomic studies
Book Synopsis Clinical Research Informatics by : Rachel Richesson
Download or read book Clinical Research Informatics written by Rachel Richesson and published by Springer Science & Business Media. This book was released on 2012-02-15 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.
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
Book Synopsis Contemporary medicine: Making sense of implementation models and methods by : Michele Mario Ciulla
Download or read book Contemporary medicine: Making sense of implementation models and methods written by Michele Mario Ciulla and published by Frontiers Media SA. This book was released on 2022-06-01 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt:
