Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions about Medicinal Products, volume II PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions about Medicinal Products, volume II PDF full book. Access full book title Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions about Medicinal Products, volume II by Kenneth K. C. Lee. Download full books in PDF and EPUB format.
Author: Kenneth K. C. Lee
Publisher: Frontiers Media SA
ISBN: 2832548555
Category : Science
Languages : en
Pages : 112
Get Book Here
Book Description
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.
Author: Kenneth K. C. Lee
Publisher: Frontiers Media SA
ISBN: 2832548555
Category : Science
Languages : en
Pages : 112
Get Book Here
Book Description
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.
Author: Kenneth K. C. Lee
Publisher: Frontiers Media SA
ISBN: 2889760685
Category : Science
Languages : en
Pages : 156
Get Book Here
Book Description
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
Get Book Here
Book Description
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: 030948832X
Category : Medical
Languages : en
Pages : 231
Get Book Here
Book Description
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.
Author: Harry Yang
Publisher: CRC Press
ISBN: 0429676824
Category : Mathematics
Languages : en
Pages : 191
Get Book Here
Book Description
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
Author: OECD
Publisher: OECD Publishing
ISBN: 9264244565
Category :
Languages : en
Pages : 202
Get Book Here
Book Description
This report identifies eight key data governance mechanisms to maximise benefits to patients and to societies from the collection, linkage and analysis of health data, and to minimise risks to both patient privacy and the security of health data.
Author: Adam Bohr
Publisher: Academic Press
ISBN: 0128184396
Category : Computers
Languages : en
Pages : 385
Get Book Here
Book Description
Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data
Author: David H. Peters
Publisher: World Health Organization
ISBN: 9241506210
Category : Medical
Languages : en
Pages : 69
Get Book Here
Book Description
Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.
Author: David E. Nelson (M.D.)
Publisher:
ISBN: 019538153X
Category : Health & Fitness
Languages : en
Pages : 340
Get Book Here
Book Description
The demand for health information continues to increase, but the ability of health professionals to provide it clearly remains variable. The aim of this book is (1) to summarize and synthesize research on the selection and presentation of data pertinent to public health, and (2) to 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 in typical real-world situations. Because communication is complex and no one approach works for all audiences, the authors emphasize how to communicate data "better" (and in some instances, contrast this with how to communicate data "worse"), rather than attempting a cookbook approach. The book contains a wealth of case studies and other examples to illustrate major points, and actual situations whenever possible. Key principles and recommendations are summarized at the end of each chapter. This book will stimulate interest among public health practitioners, scholars, and students to more seriously consider ways they can understand and improve communication about data and other types of scientific information with the public, policy makers, and the press. Improved data communication will increase the chances that evidence-based scientific findings can play a greater role in improving the public's health.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483
Get Book Here
Book Description
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
