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:
- Review what is known and unknown about the pathophysiology of shock.
- Review published literature and identify gaps.
- Discuss current clinical practices and the evidence base.
- Pathophysiology of shock and associated syndromes: From impending shock to futility Navin Kapur, MD (Tufts)(10 min)
- Review of trials to date in cardiogenic shock E. Magnus Ohman, MD (Duke)(10 min)
- Current cardiovascular management tools & best practice for shock: drugs, surgically implanted and percutaneous devices Joseph Rogers, MD (Duke)( 10 min)
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”
- Clinical/best practice perspective Alexander Truesdell, MD (INOVA)
- Industry perspective Philip Adamson, MD (Abbott)
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?
- Clinical/best practice perspective Ian Gilchrist, MD (Penn State)
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
- Clinical/best practice perspective Andrew Althouse, PhD (University of Pittsburgh)
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