The upcoming CSRC meeting will begin with an update on year-to-date activities of the consortium.
- This year's "hot topic:" the introduction of an FDA pilot program, which provides a focus on pre-market surveillance of "real-time" safety data within the context of an oncology clinical trial.
- Discussion focus: changing role of cardiovascular safety monitoring and its implications for sponsors and investigators.
Read CSRC's latest publication featured in the July 2017 issue of American Heart Journal:
Register now for the CSRC meeting and "Detection, Assessment and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development" think tank October 24-25, 2017.
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 email@example.com.
October 24-25, 2017
Register now for our upcoming CSRC meeting and cardio oncology think tank!
Reserve your hotel room here.
CSRC Meeting: "FDA Pilot Study Discussion"
Think tank: "Detection, Assessment and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development"
November 1, 2017
- 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.