January 29, 2021
CSRC Shock Mini Think Tank
All are welcome to attend either or both sessions of this virtual meeting. Previous think tank attendance not required.
Session 1: 10:00 am – 1:00 pm EST
Informed Consent Working Group (click here for full agenda)
- Review and refine key Informed Consent issues and possible solutions identified in 2020
- Identify workflows for deliverables in 2021 and beyond
Leading the discussion: Ian Gilchrist, MD (Penn State), Mitch Krucoff, MD (Duke), Dave Morrow, MD (Brigham & Women's), Ileana Pina, MD (FDA), John Sapirstein, MD (FDA), Nick West, MD (Abbott Vascular)
Session 2: 2:00 pm – 5:00 pm EST
Networks and First Clinical Question (click here for full agenda)
- Review the overarching aim of a Vascular Access Safety Bundle research program
- Discuss the prototype data collection instrument for vascular access safety
- Identify a network of centers for pilot data collection on vascular access practices
Leading the discussion: Ian Gilchrist, MD (Penn State), Dave Morrow, MD (Brigham & Women's), Alastair Proudfoot, MD (St. Bart's London), Marc Samsky, MD (Duke), Alex Truesdell, MD (INOVA)
REGISTER HERE (Online Survey Software | Qualtrics Survey Solutions)
*If you cannot attend, check back in February for a link to the recorded session.
Webinar: Implications of the COVID-19 Pandemic on Cardiovascular Issues in Clinical Trials. Remote Monitoring of Cardiac Safety: Practical and Regulatory Issues
In this hour-long CSRC webinar, FDA representatives from CDER and CDRH joined industry experts in research and cardiac safety to discuss current guidance for cardiac safety monitoring in clinical trials, as well as strategies to maintain the integrity of clinical trial research during the COVID-19 pandemic.
This webinar was held on October 16. The full recording is available here.
Annual Meeting Postponed
The CSRC Annual Meeting originally scheduled for June 8, 2020 has been postponed. We are currently developing plans for a virtual meeting and will contact the CSRC community as soon as plans have been finalized.
New Publications Available
Two new CSRC papers were recently published in American Heart Journal. Click the links below to access the materials.
- Assessing cardiac safety in oncology drug development
- Restricted mean survival time for the analysis of cardiovascular outcome trials assessing non-inferiority: Case studies from antihyperglycemic drug development
New CSRC Executive Director Named
Congratulations to Jonathan Seltzer, MD, MBA, MA for being named CSRC's Executive Director! Dr. Seltzer serves on CSRC's Executive Committee and Scientific Programs Committee.
The Cardiac Safety Research Consortium is dedicated to advancing scientific knowledge on cardiac safety for new and existing medical products by building a collaborative environment based upon the principles of the FDA’s Critical Path Initiative as well as other public health priorities.
Initiatives and Projects
For more than a decade, we have made great strides in advancing knowledge of cardiac safety in clinical research through conferences, publications, and research projects. We are currently planning for the following think tanks in 2018:
New Advances in the Assessment of Drug-Induced Arrhythmias and the Comprehensive In Vitro Proarrythmia Assay (CiPA) (Spring)
Understanding Cardiogenic Shock and Defining the Concept of “Pre-shock” (Fall)
- Concept of "pre-shock" and develop consensus statements for clinical/research use
- Mechanical circulatory support in treating "pre-shock"
Novel Approaches for the Evaluation of Mobile Technologies in CV Medicine — Scientific rigor, Innovative Methods, Regulatory Acceptance (Fall)
- Integrating devices into supporting cardiovascular safety and efficacy endpoints
- Promised efficiencies of mobile technology in clinical trials
- Device features, patient features, endpoint validation, and regulatory considerations
- Arrhythmia Normal Limits Combined Holter/12 Lead ECG Analysis
- CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot Study
Submit Your Ideas
SUBMIT YOUR IDEAS FOR THINK TANKS AND PUBLICATIONS
In order to promote the spirit of collaboration the CSRC highly values, we ask that you submit your ideas for future research projects, think tanks, and white papers. By hearing directly from our members, we can ensure that the topics researched, discussed and published are important to you.
CSRC members benefit from engaging in pre-competitive collaboration with cardiac safety professionals on vital research topics and projects. Working together, we have the opportunity to accomplish public health objectives that no single stakeholder could achieve on its own. The CSRC takes to heart the African proverb shared at one of our pediatric safety think tanks:
“If you want to go fast, go alone. If you want to go far, go together.”
In that spirit, we celebrate our second decade of excellence in
cardiac safety research, and going there together.