Thank you to everyone who attended our October meeting and oncology think tank! Look for meeting materials in the coming days.
Read CSRC's latest publication featured in the July 2017 issue of American Heart Journal:
We're on Twitter - follow us @CardiacSafety to join the conversation!
View photos from our Comprehensive In Vitro Proarrhythmia Assay (CIPA) update meeting:
Want to see more from our 10th Anniversary Meeting? Watch a recap in the photos below.
FACT: Cardiovascular disease is the leading cause of death in the United States, accounting for more than 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 on the heart. Moreover, cardiac safety concerns are a leading cause for the recall of marketed drugs and abandonment of drug development programs across all indications. The Cardiac Safety Research Consortium (CSRC) began 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 utilizing waveform data released by the FDA ECG warehouse, think tank 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 post-market 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.
DIA Annual Meeting
Join the CSRC for a session at the DIA Annual Meeting in Boston June 24-28, 2018. Details to come.
CSRC Pilot Study Training Session
Save the date! We are partnering with Parent Heart Watch for a training session at the 13th Annual Heart-to-Heart Meeting in Savannah, GA on January 12, 2018 at 3 p.m. EST. Registration information and travel information now available.
- CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot Study
- 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:
- Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices.
- Prevention of Sudden Cardiac Death in the Young: Developing a Rational, Reliable, and Sustainable National Heath Care Resource
- Clinical event adjudication in cardiovascular device trials: A Food and Drug Administration perspective
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.