Related: Sentinel IMPACT-AFib
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.
Webinar November 17: Transforming Pragmatic Clinical Trials with Sentinel IMPACT-AFib
On November 17, 2016, CTTI will host a webinar to provide an update on work being done as part of the Uses of Electronic Healthcare Data project. Through this project, CTTI is helping the FDA evaluate the use of its Sentinel System as a national resource for generating evidence that can guide medical decision-making. The Sentinel System was designed as a distributed database of claims data for conducting safety surveillance; the data remain in participating partners’ secure environments for analysis.
Using the Sentinel System for clinical trials has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials. This free webinar will discuss the Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). This proof-of-concept trial will be the first conducted using the Sentinel infrastructure and will serve as a pilot for future intervention studies that address critical public health needs.
IMPACT-AFib will randomize 40,000 patients and providers to test whether a multi-level educational intervention can increase the initiation of oral anticoagulation use among patients with atrial fibrillation meeting guidelines for stroke prevention who have not received such therapy in the preceding year. The trial will also assess outcomes associated with the treatment, including stroke.
Date & Time: Thursday, November 17, 2016, at 12:00 p.m. EST (New York, GMT-05:00)
Presenters:
- Chris Granger, MD, FACC, FAHA, Professor of Medicine, Division of Cardiology, Duke University Medical Center
- Sean Pokorney, MD, MBA, Cardiology Fellow, Duke University
When it’s time, click here to join the meeting.
This webinar is OPEN TO THE PUBLIC. Please share with your colleagues!