What is the project focus?
As ACTION has matured, we have determined that setting up a clinical trial model, using real world data through our network, represents an effective way to get new therapies to the bedside. ACTION can add needed efficiencies from the bench to the bedside implementation processes, such as:
- Develop and foster a group of providers that can vet therapies for children and collaborate with all stakeholders to get the product to the bedside.
- Streamline regulatory processes and timely data entry.
- Distribute Patient-Reported Outcome surveys as trial end-points (we expect this will be a component of many future projects).
- Ensure data quality (leveraging our growing experience with data adjudication and review).
- Provide an established collaborative study environment of providers that work well together.
- Encourage engagement of stakeholders from all specialties.
- Wearable technology and data collection can be used as additional trial end points.
We have continued to refine and improve our model for collecting real-world data and are using data from the ACTION registry to support our first pediatric device trial. The ACTIVE Berlin EXCOR driver trial will be performed through the ACTION network at 20 participating sites.
For more information about the Active Driver trial, contact us.
Who is impacted?
All children that are implanted with the Berlin Heart EXCOR®at an ACTION trial site.
What are we doing to help?
We are using our collaborative to bring medicines and devices to children in a more effective and efficient manner.