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RAPID PASSION CV Virtual Think Tank - January 2024
Tue, Jan 09
|Virtual Event
Registry-Supported Infrastructure Development for Prospective Trials: Pathways for DEI and “Long, Long” Term Vital Status Use Cases
Registration is closed
See other eventsTime & Location
Jan 09, 2024, 12:00 PM EST – Jan 10, 2024, 4:00 PM EST
Virtual Event
About the Event
Meeting Objectives:
- Pragmatic aspects of CV device research approaches to DEI issues.
- Pragmatic aspects of developing a streamlined, high quality, "long, long" (> 5 yr) vital status profile that could be predictably and reliably accessed by clinical trial sponsors and sufficient for public health safety assessments going forward.
DRAFT AGENDA as of 12_03_23
I. Welcome & Opening Remarks
II. Session I: Long, Long (> 5yr) Follow Up
- Update on FDA Perspective of Paclitaxel PAD Interventions and 5 Year Safety
- 10-year TAVR follow up: An Industry View
- Subtle sources of bias in long term PTX-PAD and TAVR follow up: A statistician’s perspective of lessons learned
- Defining 10-year vital status: What data do we need?
- Defining 10-year vital status: Where do we get the data we need?
- Discussion Panel
III. BREAK
IV. Session II: DEI Use Cases: Defining the Details
- Overview of the FDA DEI Draft Guidance
- Tools and Metrics to Document and Improve DEI in Research
- Registry Role(s) To Facilitate DEI in Prospective Trials
- DEI and Heart Valve Perspective
- Discussion Panel
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