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Examining the Impact of Real-World Evidence on Medical Product Development - Proceedings of a Workshop Series (Paperback)
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Discovery Miles 16 750
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Examining the Impact of Real-World Evidence on Medical Product Development - Proceedings of a Workshop Series (Paperback)
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Total price: R1,695
Discovery Miles: 16 950
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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. Table of Contents Front Matter 1
Introduction 2 Perspectives on Real-World Evidence 3 Learning from
Success 4 Barriers and Disincentives to the Use of Real-World
Evidence and Real-World Data 5 Getting Unstuck: Mythbusting the
Current System 6 When Is a Real-World Data Element Fit for
Assessment of Eligibility, Treatment Exposure, or Outcomes? 7 How
Tightly Should Investigators Attempt to Control or Restrict
Treatment Quality in a Pragmatic or Real-World Trial? 8 Obscuring
Intervention Allocation in Trials to Generate Real-World Evidence:
Why, Who, and How? 9 Gaining Confidence in Observational
Comparisons 10 Looking Ahead References Appendix A: Related
Resources Appendix B: Workshop One Agenda Appendix C: Workshop Two
Agenda Appendix D: Workshop Three Agenda
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