Focus on Shock
Cardiogenic Shock: Defining the Clinical and Regulatory Landscape
Cardiogenic shock (CS) is a leading cause of mortality associated with acute myocardial infarction (AMI). Unfortunately, the incidence of CS is increasing and there are no prospective randomized trials providing data to guide care. The Cardiac Safety Research Consortium (CSRC) ThinkTank “Defining the Clinical and Regulatory Landscape for Cardiogenic Shock” was therefore convened in September 2018 in Washington, DC, to attempt to address these issues. Physician experts, US and Canadian regulators, and industry leaders met to discuss current clinical best practices, barriers to generating prospective evidence, areas of CS care that have not been studied, and future directions for approaches to device and drug development evidence for therapies in CS.
Since this initial ThinkTank in September 2018, two follow up ThinkTanks have been convened and 5 key initiatives have been identified as the focus of future CSRC CS efforts. The first initiative is to establish a CS network to support and conduct research with an emphasis on reliable data collection and reporting. Second, to engage with existing CS research collaboratives and to identify potential financial and non-financial resources to support future CS research. Third, to leverage the academic research consortium (ARC) and establish a SHOCK-ARC (SHARC) to create fit-for-purpose definitions to be used in CS research. Fourth, to develop a set of feasible research questions that would lead to pragmatic randomized trials of interest to a broad range of CS stakeholders. Finally, to establish strategies that allow for more streamlined informed consent of patients that participate in future CS randomized trials.
There are five CSRC working groups that focus on shock. These groups have led three Think Tank meetings, resulting in one publication Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock with two more in process.
Each working group holds biweekly calls.
If you are interested in learning more about how to get involved, please email us at firstname.lastname@example.org.
|Shock Working Groups||Chairs|
|Network||Alastair Proudfoot, MBChB, MRCP, FFICM, PhD|
Alex Truesdell, MD
Bill O’Neill, MD
Navin Kapur, MD, FAHA, FACC, FSCAI
|SHARC||Bill Abraham, MD, FACP, FACC|
Ron Waksman, MD
|Resources||Judy Hochman, MD|
Sunil Rao, MD
|First Question||David Morrow, MD|
Holger Thiele, MD
|Informed Consent||Nick West, MD|
John Sapirstein, MD (FDA)
CSRC Therapeutic Area Committees
- Hypertension/Vascular Disease
- Pediatric Cardiology