Cardiac Safety

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 cardiacsafety@dm.duke.edu.

CURRENT PROJECTS

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

 

UPCOMING EVENTS

October 18-19, 2016

Registration NOW OPEN: Click HERE to register

Day 1: CSRC 10th Annual Meeting

Draft Agenda

Plenary Speaker: Janet Woodcock, MD (FDA)

Please don’t miss this opportunity to commemorate our accomplishments, plan for the future, and discuss hot topics in cardiac safety

Day 2: CSRC Think Tank: Cardiac Safety Assessment- Opportunities Beyond the Randomized Clinical Trial?

Draft Agenda

Objectives of the Think Tank: RCTs are the most robust form of clinical evidence and used to support regulatory decision-making.   The purpose of this Think Tank is to discuss the utility of alternative data sources in a post approval setting to better inform decision making regarding a potential CV safety signal. Where can these approaches have a clinically meaningful impact on drug development? The goal will be to achieve identify areas of consensus where approaches can be used.

FDA Headquarters White Oak Campus | Silver Springs, Maryland

Host Hotel Information

December 6-7, 2016

Registration Opening Soon

Day 1: Co-Sponsor with HESI

Comprehensive In Vitro Proarrhythmia Assay (CIPA) Update Meeting

Day 2:

Part A: QTc Exposure-Response Modeling Workshop: What is Required?

Part B: Endpoints When Treating VT/VF in Patients with ICDs

Draft Agenda

Host Hotel Information

 

newsupdates4
Take a look at our newly published white papers
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.

*If you would like to get involved,
please contact us at cardiacsafety@dm.duke.edu.

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