CSRC Think Tank: Defining the Clinical and Regulatory Landscape for Cardiogenic Shock

September 7, 2018

8:00am – 8:15am Introduction and Purpose of Think Tank Mitchell Krucoff, MD (Duke)

  • Introduction to CSRC
  • Anatomy of a Think Tank

8:15am – 8:45am Session I: Overview of shock

Session I Objectives:

8:45am – 9:00am BREAK

9:00am – 10:30am Session II: Defining unmet needs, clinical study barriers, and targets for drug and device therapy for shock: Part I Moderator: Joseph Rogers, MD (Duke)

Session II Objectives:

  • Define a population of intended use for drug and device therapies in cardiogenic shock.
  • Discuss and identify comparator cohorts for cardiogenic shock trials.
  • Discuss and identify primary and secondary outcomes for cardiogenic shock trials.

9:00am – 9:10am Cohorts to study: defining a “population of intended use”

9:10am – 9:20am Comparators for drug and device trials in shock patients

  • Clinical/best practice perspective Judith Hochman, MD (NYU Langone)

9:20am – 9:30am Outcome endpoints: mortality plus?

9:30am – 9:40am FDA Perspective Ileana Pina, MD
9:40am – 9:50am Health Canada Perspective Roy Masters, MD
9:50am – 10:30am Discussion

  • Lead Discussant: Ron Waksman, MD (Medstar Health)

10:30am – 10:45am BREAK

10:45am -12:15pm Session III: Defining unmet needs, clinical study barriers, and targets for drug and device therapy for shock: Part II | Moderator: David Morrow, MD MPH (Harvard)

Session III Objectives:

  • Discuss enrollment of patients who may not be capable of providing informed consent.
  • Discuss and identify novel evidence structures for future shock trials.
  • Discuss and identify novel statistical approaches for trials of shock therapies.

10:45am – 10:55am Informed consent

  • Clinical/best practice perspective Timothy Henry, MD (Cedars-Sinai)

10:55am – 11:05am Avenues for real world evidence, pragmatic trials, or novel infrastructure for shock trials

  • Clinical/best practice perspective Holger Thiele, MD (University of Leipzig)

11:05am – 11:15am Novel statistical approaches for shock studies

11:15am – 11:20am Improving Patient Outcomes in Cardiogenic Shock as a core mission of clinical development programs Seth Bilazarian, MD (Abiomed)

11:20am-11:30am FDA Perspective John Sapirstein, MD

11:30am – 12:10pm Discussion

  • Lead Discussant: Roseann White, MA (Duke)

12:10pm – 1:00pm LUNCH

1:00pm – 2:00pm Session IV: Future directions for device and drug development in shock. Moderator: Sunil Rao, MD (Duke)

Session IV Objectives:

  • Identify global collaborators for trials of shock therapies.
  • Discuss trial designs incorporating both drug and device therapies for patients with cardiogenic shock.
  • Discuss and define “-ARC” definitions of shock (SHARC).

1:00pm – 1:10pm Global collaboration: is it possible? Is it desirable? Clinical/best practice perspective William Abraham, MD (Ohio State)

1:10pm – 1:20pm Factorial device and drug study designs

  • Clinical/best practice perspective Roxana Mehran, MD (Mount Sinai)

1:20pm – 1:30pm Definitions: Shock-ARC (SHARC)

  • Clinical/best practice perspective George Dangas, MD (Mount Sinai)

1:30pm-1:40pm FDA Perspective Fortunato Senatore, MD, PhD
1:40pm – 2:30pm Discussion
2:30pm – Closing Remarks