Publication Overview
Darpo B, et al. Cardiac Safety Research Consortium: Can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward. Am Heart J. 2014; 168(3): 262-272.
This landmark report from the Cardiac Safety Research Consortium (CSRC) evaluates the scientific feasibility of utilizing early-stage clinical pharmacology data to evaluate proarrhythmic risk, potentially bypassing the need for a standalone Thorough QT (TQT) study in specific development programs.
News & Updates
CSRC and ACCP Sign Collaborative Memorandum of Understanding
Through the partnership, CSRC and ACCP will develop, plan, and conduct various educational events and programs. They will also produce research and policy statements/position papers regarding clinical pharmacology and cardiac and vascular safety of medical products.
Current Projects
CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot Study
The mission of the Cardiac Safety Research Consortium is to advance regulatory science specifically related to pre-competitive cardiac safety issues. This includes the study of underlying mechanisms of Cell Death and pathology in pediatric and young adult populations to prevent sudden cardiac events.
The CSRC stands fully ready to encourage, contribute to, embrace and support elements of clinical science such as good scientific design, data analysis, interpretation and dissemination to the public domain within the construct of the resources and committee structure of the public-private partnership forum.
Upcoming Events
- POSTPONED: CSRC Re-Launch Annual Meeting
- ONGOING: Technical Specification for Submitting Data for QT Studies
