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Real-World Evidence Generation and Evaluation of Therapeutics

2017-07-05 Medical
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Release : 2017-07-05
Genre : Medical
Kind : eBook
Book Rating : 650/5 ( reviews)

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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. This book was released on 2017-07-05. 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 Generation and Evaluation of Therapeutics

2017-08-05 Medical
Download Real-World Evidence Generation and Evaluation of Therapeutics PDF Online Free

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Release : 2017-08-05
Genre : Medical
Kind : eBook
Book Rating : 626/5 ( reviews)

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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. This book was released on 2017-08-05. 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.

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

2019-04-05 Medical
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Release : 2019-04-05
Genre : Medical
Kind : eBook
Book Rating : 32X/5 ( reviews)

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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. This book was released on 2019-04-05. 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.

Real-World Evidence in Drug Development and Evaluation

2021-01-11 Mathematics
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Release : 2021-01-11
Genre : Mathematics
Kind : eBook
Book Rating : 824/5 ( reviews)

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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. This book was released on 2021-01-11. 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

Registries for Evaluating Patient Outcomes

2014-04-01 Medical
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Release : 2014-04-01
Genre : Medical
Kind : eBook
Book Rating : 333/5 ( reviews)

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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. This book was released on 2014-04-01. 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.

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