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A Study of Real-world, Real-time Data Capture and Analysis

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Release : 1984
Genre :
Kind : eBook
Book Rating : /5 ( reviews)

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Book Synopsis A Study of Real-world, Real-time Data Capture and Analysis by : M. Atiquzzaman

Download or read book A Study of Real-world, Real-time Data Capture and Analysis written by M. Atiquzzaman. This book was released on 1984. Available in PDF, EPUB and Kindle. Book excerpt:

The Science of Real-Time Data Capture

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Author :
Release : 2007-04-19
Genre : Medical
Kind : eBook
Book Rating : 458/5 ( reviews)

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Book Synopsis The Science of Real-Time Data Capture by : Arthur Stone

Download or read book The Science of Real-Time Data Capture written by Arthur Stone. This book was released on 2007-04-19. Available in PDF, EPUB and Kindle. Book excerpt: The National Cancer Institute (NCI) has designated the topic of real-time data capture as an important and innovative research area. As such, the NCI sponsored a national meeting of distinguished research scientists to discuss the state of the science in this emerging and burgeoning field. This book reflects the findings of the conference and discusses the state of the science of real-time data capture and its application to health and cancer research. It provides a conceptual framework for minute-by-minute data capture- ecological momentary assessments (EMA)- and discusses health-related topics where these assessements have been applied. In addition, future directions in real-time data capture assessment, interventions, methodology, and technology are discussed. Despite the rapidly growing interest in the methodology of real-time data capture (e.g. journal special issues, widely attended conference presentations, etc.), to date no single book has focused solely on this topic. The volume will serve as an important resource for researchers, students, and government scientists interested in pursuing real-time health research, and will nicely complement our lists in epidemiology, public health, and oncology.

The Science of Real-Time Data Capture

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Author :
Release : 2007-04-19
Genre : Medical
Kind : eBook
Book Rating : 718/5 ( reviews)

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Book Synopsis The Science of Real-Time Data Capture by : Arthur Stone

Download or read book The Science of Real-Time Data Capture written by Arthur Stone. This book was released on 2007-04-19. Available in PDF, EPUB and Kindle. Book excerpt: The National Cancer Institute (NCI) has designated the topic of real-time data capture as an important and innovative research area. As such, the NCI sponsored a national meeting of distinguished research scientists to discuss the state of the science in this emerging and burgeoning field. This book reflects the findings of the conference and discusses the state of the science of real-time data capture and its application to health and cancer research. It provides a conceptual framework for minute-by-minute data capture- ecological momentary assessments (EMA)- and discusses health-related topics where these assessements have been applied. In addition, future directions in real-time data capture assessment, interventions, methodology, and technology are discussed.Despite the rapidly growing interest in the methodology of real-time data capture (e.g. journal special issues, widely attended conference presentations, etc.), to date no single book has focused solely on this topic. The volume will serve as an important resource for researchers, students, and government scientists interested in pursuing real-time health research, and will nicely complement our lists in epidemiology, public health, and oncology.

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

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Author :
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.

ePro

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Author :
Release : 2016-05-13
Genre : Business & Economics
Kind : eBook
Book Rating : 911/5 ( reviews)

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Book Synopsis ePro by : Brian Tiplady

Download or read book ePro written by Brian Tiplady. This book was released on 2016-05-13. Available in PDF, EPUB and Kindle. Book excerpt: Patient self-reported data has become increasingly important in today's clinical trials. Trials in some disease indications rely upon patient recorded diary data as the primary endpoint to demonstrate drug efficacy - including, for example, indications such as insomnia, migraine and pain. In addition, improvements in quality of life measured using patient questionnaires can now be included as claims on drug labelling. Traditionally these data have been collected using paper questionnaires and diaries issued to subjects. Regulators and the industry have become increasingly aware of the limitations of recording patient reported outcomes data on paper including data quality and integrity issues. As a result there is a growing interest in collection of patient reported outcomes data using electronic means (ePRO). Solutions include handheld PDAs, Interactive Voice Response (IVR) systems, and other site-based hardware such as touchscreen PCs. Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. These include: ¢ How should instruments developed on paper be adapted for electronic use, and what degree of validation should be done between paper and electronic forms? ¢ How can researchers ensure they are complying with regulatory requirements including the PRO guidance published by FDA in 2009 when using ePRO solutions? ¢ Can fewer patients be exposed in a clinical trial as a result of improved data quality obtained using electronic diaries? ¢ What type of solution should be used for certain patient populations and protocols, and how can ePRO solutions be designed optimally to increase patient acceptability and compliance? Bill Byrom and Brian Tiplady's ePro addresses all these issues, reviews the new FDA guidance, and provides a very contemporary view on this important subject.

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