The American Heart Journal has published CSRC's new white paper, "Long-term Electrocardiographic Safety Monitoring in Clinical Drug Development," in the May 2017 issue.
FDA Center for Drug Evaluation and Research (CDER) announces new formalized process for staff engagement with Public Private Partnerships (PPPs) and consortia. Read the full Manual of Policies and Procedures.
CSRC Develops Pediatric National Pilot Study, "CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse."
We're on Twitter - follow us @CardiacSafety to join the conversation!
Enjoy photos from the December 6-7 Sessions
Check out photos from the 10th Anniversary Meeting
Cardiovascular disease is the leading cause of death in the United States, accounting for over one quarter of all deaths every year
Some medical products intended to treat cardiovascular disease and other diseases have significant and potentially dangerous side effects related to their effects on the heart. Moreover, cardiac safety concerns are a leading cause for the recall of marketed drugs and abandonment of drug development programs for any indication. The Cardiac Safety Research Consortium (CSRC) was launched in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University to support research into the evaluation of cardiac safety of medical products.
CSRC supports research by engaging stakeholders from industry, academia, and government to share data and expertise. Outputs of the CSRC include research projects taking advantage of waveforms released from the FDA ECG warehouse, Think Tank Incubator programs, and consensus white papers. Additional work is under way to expand the portfolio of research projects beyond the ECG data into other areas of cardiac safety evaluation from the preclinical through the postmarket periods.
The CSRC is excited about its past accomplishments and future directions. If you are interested in exploring current opportunities for involvement with the CSRC, please email us at firstname.lastname@example.org.
See below for key dates for our 2017 Annual Meeting and think tank. Registration and event details coming soon!
CSRC Annual Meeting
Think tank, "Detection, Assessment and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development"
- CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot Study
- Enhancing Cardiac Safety though the Use of Social Media
- Development of A Rational, Reliable and Sustainable National Health Care Resource Pediatric Warehouse
- Development of A Rational, Reliable and Sustainable National Health Care Resource Pediatric Screening Tools/ Processes
- Restricted Mean Survival Time (RMST) statistical analysis approach for analyzing Diabetes Cardiovascular Outcomes Trials
- Arrhythmia Normal Limits
- Combined Holter/12 Lead ECG Analysis
NEWS & UPDATES
Take a look at our newly published white papers
- Long-term Electrocardiographic Safety Monitoring in Clinical Drug Development: A Report from the Cardiac Safety Research Consortium
- The Cardiac Safety Research Consortium enters its second decade
IQ-CSRC Study Waveform Sharing Program
The IQ-CSRC Study Waveform Data Sharing Program allows interested ECG core laboratories to access a validation dataset to test the ability to accurately characterize QT effects in a manner consistent with the alternative approach to the TQT.
The mission of the Cardiac Safety Research Consortium is to advance regulatory science specifically related to pre-competitive cardiac safety issues through the collaborative means of a public-private partnership across interested stakeholders. 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.
The CSRC does not endorse specific commercial technologies, entities, products, or services. Any communications to the contrary, written or otherwise, are inaccurate.