Innovation
Regulatory Science and Reimbursement Learning Series
FDA Townhall Meeting
Episodes
Pros and Cons of the Win Ratio as the Primary Endpoint for Pivotal Heart Failure Trial
10 min.
Strengths and Limitations of a Two-Phase (6-Month Intermediate Endpoints & 12-18 Month Mortality and Heart Failure Hospitalization) Design for Trials on Chronic Heart Failure Devices
10 min.
Regulatory Aspects for Chronic Heart Failure Devices - FDA Perspective
10 min.
Application of Exception from Informed Consent to a Multicenter Cardiogenic Shock Trial
9 min.
Regulatory Questions on Device Trials for Acute Decompensated Heart Failure - FDA Perspective
6 min.
How Tightly Should Treatment Algorithms Be Prescribed in a Clinical Trial on Cardiogenic Shock? What Are The Key Treatment Protocol Elements?
9 min.
How Narrow or Broad Should Enrollment Criteria Be in Trials on Cardiogenic Shock to Achieve Clinically Interpretable Results?
7 min.
Clinically Meaningful and Practical Pivotal Trial Endpoints for Devices in Acute Decompensated Heart Failure
9 min.
Invasive Investigational Device IDE Studies for Acute Decompensated Heart Failure: For Diuretic-Resistant Patients Only?
9 min.
Early Feasibility Studies (EFS) “2.0”: The Next Decade
26 min.
The Transformative Potential of Digital Health Strategies to Impact Clinical Research and Patient Outcomes
15 min.
The Importance of Pre-emptive TAVR in the Future Management of Aortic Stenosis
13 min.
Strengths and Limitations of Patient Reported Outcomes as Major Endpoints in "Modern Era" CV Trials
12 min.
Cardiogenic Shock Trials: Defining the Clinical Need and Framing the Issues
10 min.
Transformative Changes in Clinical Research: A Futurist’s Viewpoint
16 min.
Health Equity Issues in Clinical Trials: Can We Accelerate Progress?
15 min.
FDA Recovering From a Pandemic: Lessons Learned and Future Adjustments
10 min.
FDA Update on EFS Requirements for TTVR Technologies
9 min.