FDA-Catalyst—Using FDA’s Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial Article Swipe
Noelle M. Cocoros
,
Sean D. Pokorney
,
Kevin Haynes
,
Crystal Garcia
,
Hussein R. Al‐Khalidi
,
Sana M. Al‐Khatib
,
Patrick Archdeacon
,
Jennifer C. Goldsack
,
Thomas Harkins
,
Nancy D. Lin
,
David Martin
,
Debbe McCall
,
Vinit Nair
,
Lauren E. Parlett
,
Robert Temple
,
Cheryl N. McMahill‐Walraven
,
Christopher B. Granger
,
Richard Platt
·
YOU?
·
· 2018
· Open Access
·
· DOI: https://doi.org/10.1177/1740774518812776
YOU?
·
· 2018
· Open Access
·
· DOI: https://doi.org/10.1177/1740774518812776
Background: The US Food and Drug Administration’s Sentinel Initiative is well positioned to support pragmatic clinical trials. FDA-Catalyst combines direct contact with health plan members and/or providers with data in the Sentinel infrastructure. Here, we describe the rationale, feasibility analyses, and lessons learned from the planning phase of the first large pragmatic trial conducted using the Sentinel Initiative’s delivery system capabilities—IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (the IMPACT-AFib trial). Methods: During the planning phase, we convened representatives from five commercial health plans, FDA, study coordinating centers, and a patient representative for protocol development, institutional review board preparation, and other activities. Administrative claims data from the plans were included in a retrospective cohort analysis to assess sample size for the trial. Members ≥30 years old with ≥365 days of medical/pharmacy coverage, ≥2 diagnosis codes for atrial fibrillation, a guideline-based indication for oral anticoagulant use for stroke prevention, and no evidence of oral anticoagulant use in the 365 days prior to the index atrial fibrillation diagnosis in 2013 were included. Exclusions for the analysis included other conditions requiring anticoagulation, history of intracranial hemorrhage, and gastrointestinal bleed. We calculated rates of oral anticoagulant use, transient ischemic attack or stroke, and bleeding in the 365 days following the index atrial fibrillation diagnosis. Results: A total of 44,786 members with atrial fibrillation with no evidence of recent oral anticoagulant use were identified. In total, 87% (n = 38,759) were classified as having a guideline-based indication for oral anticoagulants. Of those, 33% (n = 12,867) had a new oral anticoagulant dispensed during the following year, 15% (n = 5917) were hospitalized for stroke or transient ischemic attack, and 9% (n = 3469) for bleeding events. This information was used to develop the trial protocol including sample size, power calculations, and level of randomization. Conclusion: Sentinel infrastructure generated preliminary data that supported planning and implementation of a large pragmatic trial embedded in health plans. This planning identified unanticipated challenges that must be addressed in similar trials.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1177/1740774518812776
- https://journals.sagepub.com/doi/pdf/10.1177/1740774518812776
- OA Status
- bronze
- Cited By
- 19
- References
- 11
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2901894544
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W2901894544Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1177/1740774518812776Digital Object Identifier
- Title
-
FDA-Catalyst—Using FDA’s Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2018Year of publication
- Publication date
-
2018-11-16Full publication date if available
- Authors
-
Noelle M. Cocoros, Sean D. Pokorney, Kevin Haynes, Crystal Garcia, Hussein R. Al‐Khalidi, Sana M. Al‐Khatib, Patrick Archdeacon, Jennifer C. Goldsack, Thomas Harkins, Nancy D. Lin, David Martin, Debbe McCall, Vinit Nair, Lauren E. Parlett, Robert Temple, Cheryl N. McMahill‐Walraven, Christopher B. Granger, Richard PlattList of authors in order
- Landing page
-
https://doi.org/10.1177/1740774518812776Publisher landing page
- PDF URL
-
https://journals.sagepub.com/doi/pdf/10.1177/1740774518812776Direct link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
bronzeOpen access status per OpenAlex
- OA URL
-
https://journals.sagepub.com/doi/pdf/10.1177/1740774518812776Direct OA link when available
- Concepts
-
Medicine, Atrial fibrillation, Randomized controlled trial, Guideline, Clinical trial, Rivaroxaban, Bleed, Stroke (engine), Emergency medicine, Pharmacy, Institutional review board, Warfarin, Intensive care medicine, Surgery, Internal medicine, Family medicine, Mechanical engineering, Engineering, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
19Total citation count in OpenAlex
- Citations by year (recent)
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2024: 2, 2023: 4, 2022: 3, 2021: 4, 2020: 4Per-year citation counts (last 5 years)
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11Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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