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Tue, Jan 09

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Virtual Event

RAPID PASSION CV Virtual Think Tank - January 2024

Registry-Supported Infrastructure Development for Prospective Trials: Pathways for DEI and “Long, Long” Term Vital Status Use Cases

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Time & Location

Jan 09, 2024, 12:00 PM EST – Jan 10, 2024, 4:00 PM EST

Virtual Event

About the Event

Draft Agenda

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  • Overview of the FDA DEI Draft Guidance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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