Key result
EMA, Health Canada, and FDA establish a multiregional collaboration to study DOAC safety profiles.
Why the study?
Clinical trials of direct acting oral anticoagulants did not provide comprehensive evidence for some patient groups, prompting observational studies to further characterize their safety profile.
Authors
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Supports multinational DOAC safety monitoring; leaves open effects on clinical decision-making.
Collaboration between the EMA, Health Canada, and FDA enables coordinated, large-scale observational studies to better characterize the safety profile of DOACs.
Arlett et al. (2020) conducted a review in Patients taking direct acting oral anticoagulants. Direct acting oral anticoagulants (DOACs) was evaluated. A multiregional collaboration between the EMA, Health Canada, and the FDA was established to coordinate large observational studies characterizing the safety profile of direct acting oral anticoagulants.
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