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Activity Number:
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291
- Using EHRs to Run Pragmatic Trials: Opportunities and Challenges
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Type:
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Invited
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Date/Time:
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Wednesday, August 11, 2021 : 3:30 PM to 5:20 PM
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Sponsor:
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Health Policy Statistics Section
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Abstract #316717
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Title:
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Randomized Pragmatic Clinical Trials Utilizing RWD: Myths and Realities
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Author(s):
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Frank W. Rockhold*
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Companies:
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Duke University School of Medicine
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Keywords:
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Pragmatic Clinical Trials;
Randomized Clinical Trials;
Electronic Health Records;
Real World Data;
Randomized
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Abstract:
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The Substantial Evidence Amendment to FDA Regulations was updated in 2019 to consider RWD as an adjunct to Randomized Controlled Clinical Trials (RCTs) “to consider such data and evidence to constitute substantial evidence”. There is general agreement among experts that the use of these existing healthcare data holds promise for making randomized trials more efficient and generalizable. Regulators and the academic community have outlined a framework for evaluating the use of real-world data (RWD) to support regulatory decision-making using pragmatic clinical trials (PCTs), which are randomized trials designed to inform clinical or policy decisions by assessing the real-world effectiveness of an intervention. These benefits of relying on real-world data sources must be balanced against a clear understanding of the data provenance and completeness of electronic health record (EHR) and claims data used in PCTs, as data collected solely for health needs of the patient can potentially limit their fitness for research purposes particularly for study end points. This talk will examine the role of EHR data in PCT’s and review some of the issues involved.
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Authors who are presenting talks have a * after their name.
