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Recording Now Available: Transforming Pragmatic Clinical Trials with Sentinel IMPACT-AFib

Would you like to learn how FDA’s Sentinel System is being used for the first time to conduct a randomized clinical trial?

A recording is now available of CTTI’s webinar discussing Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). The concept for IMPACT-AFib stemmed from a collaboration between CTTI and Sentinel (formerly Mini-Sentinel) on the Uses of Electronic Healthcare Data Project to evaluate the use of Sentinel for conducting randomized trials. Sentinel has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials.

About 5 million people in the United States have atrial fibrillation, and roughly 1 in 5 strokes are due to this condition, representing a significant health burden. While anticoagulation therapy is effective for stroke prevention in this population, only about half of these patients receive this therapy according to guidelines.

The proof-of-concept IMPACT-AFib trial will use the Sentinel System to assess the ability of an educational intervention to increase anticoagulation use in at-risk patients with atrial fibrillation. The webinar discusses considerations encountered in planning for this pragmatic trial:

  • Identifying eligible patients and treatments received using a distributed database with linkage to pharmacy claims
  • Conducting a pilot phase
  • Engaging data partners, providers, and patients in study development
  • Making decisions regarding randomization and informed consent

We invite you to view the recording, along with the presentation slides, to learn more about this exciting trial and the use of Sentinel to improve clinical trials.

To view recordings of other CTTI webinars, CLICK HERE.