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Examining the Impact of Real-World Evidence on Medical Product Development: II. Practical Approaches: Proceedings of a Workshop - in Brief
Pages 1-12

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From page 1...
... -- data generated outside of the traditional clinical trial setting -- and the use of RWE. Workshop discussions centered around three framing questions to help shift the discussion toward practical and generalizable considerations for those embarking on a study that would use RWE to inform decision making in the development and evaluation of medical products: 1.
From page 2...
... Similarly, some panelists and participants discussed validating data as a crucial step in using RWD for research. Berlin said that coding is not always accurate, so validated algorithms and methods should be used to accurately identify patient cohorts.
From page 3...
... ? a DISCLAIMER: This document represents discussion by individual workshop participants of the Examining the Impact of Real-World Evidence on Medical Product Development -- Workshop II: Practical Approaches.
From page 4...
... During the Day 2 discussion, several participants discussed incomplete ascertainment, due to health system issues (e.g., data fragmentation) and the likelihood of certain events occurring outside of a patient's typical health system, as a possible source of bias when collecting data.
From page 5...
... Workshop participants discussed desired standards of care in real-world treatment studies. Simon said that generally, care used in research should be at least as good as the typical standard of care in the real world.
From page 6...
... Several panelists and participants discussed the importance of blinding during different stages of the study cycle, including patient and/or provider blinding during treatment assignment, blinding of treatment group during analysis, and the blinding of assessors during outcome assessment. Simon argued that blinding of outcome assessment is critical, because the potential introduction of bias during outcome assessment is detrimental to trial results.
From page 7...
... ? a DISCLAIMER: This document represents discussion by individual workshop participants of the Examining the Impact of Real-World Evidence on Medical Product Development -- Workshop II: Practical Approaches.
From page 8...
... . Schneeweiss explained that transactional data is crucial to understand the benefits and risks of medical products outside of controlled research investigations in routine care settings.
From page 9...
... Martin responded that he views prospective observational studies as one option in a broader menu of potential study designs. He also noted that a potential strength of prospective observational studies might be that they are better able to incorporate patient preferences through the realignment of incentives.
From page 10...
... • When can we have confidence in inference from cluster-randomized or stepped-wedge study designs? a DISCLAIMER: This document represents discussion by individual workshop participants of the Examining the Impact of Real-World Evidence on Medical Product Development -- Workshop II: Practical Approaches.
From page 11...
... Building on a topic from Day 1 of the workshop, Temple and Mark McClellan of the Duke-Margolis Center for Health Policy discussed the potential use of "randomized nudge" trials as a way to improve patient adherence during studies. CLOSING REMARKS McClellan concluded the workshop by thanking the participants and reminding them that this workshop, the second in a three-part series, is part of a larger activity examining the impact of RWE on medical product development.
From page 12...
... 2018. Examining the impact of real-world evidence on medical product development: II.


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