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Innovation

Regulatory Science and Reimbursement Learning Series

FDA Townhall Meeting

Innovation >
FDA Townhall Meeting

Episodes

Pros and Cons of the Win Ratio as the Primary Endpoint for Pivotal Heart Failure Trial

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

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

Regulatory Aspects for Chronic Heart Failure Devices - FDA Perspective

10 min.

Application of Exception from Informed Consent to a Multicenter Cardiogenic Shock Trial

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

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?

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?

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

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?

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

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

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

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

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

Cardiogenic Shock Trials: Defining the Clinical Need and Framing the Issues

10 min.

Transformative Changes in Clinical Research: A Futurist’s Viewpoint

Transformative Changes in Clinical Research: A Futurist’s Viewpoint

16 min.

Health Equity Issues in Clinical Trials: Can We Accelerate Progress?

Health Equity Issues in Clinical Trials: Can We Accelerate Progress?

15 min.

FDA Recovering From a Pandemic: Lessons Learned and Future Adjustments

FDA Recovering From a Pandemic: Lessons Learned and Future Adjustments

10 min.

FDA Update on EFS Requirements for TTVR Technologies

FDA Update on EFS Requirements for TTVR Technologies

9 min.

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