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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.

Accomplishments

THE CSRC would like to Welcome the following NEW MEMBERS:

Bayer

Bristol-Myers Squibb

Boehringer Ingelheim

Portola

We look forward to working with you on future CSRC projects

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Look at our numbers......CSRC Research Projects, White Papers and Scientific Meetings participation

  • Over 575 Industry participants
  • 50 Professional Society participants
  • 220 Regulatory Agency participants
  • 250 Academic Faculty participants

Thanks for all your support over the years! 

Current Projects
  • The CSRC wants to hear from you.  Submit a Research Proposal today.

  • CSRC COPD Thinktank Synposis and Slides are now posted.  Click here to Review

  • CSRC Outcomes Thinktank Synposis and Slides are now posted.  Click here to Review

  • Cardiovascular Case Report Forms for use in Non Cardiovascular Clinical Trials are available for use. Click here to access all forms. 

  • CSRC CEC Adjudication Thinktank Synopsis and Slides are now posted. 
  • CSRC/HESI Thinktank Meeting Synopsis is available. 
  • CV Safety Consultations in Pharmaceutical Organizations (Development of Working Group)
  • ECG Database--Long QT Study is available and the SOC is acceptong Research Proposal

  

White Papers

INTERESTED IN READING ANY OF THE CSRC WHITEPAPERS?  CLICK HERE TO READ OUR PUBLICATIONS

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CSRC Opportunity: Drug Induced Cardiac Abnormalities in Premature Infants and Neonates Whitepaper if you are interested in being a part of the writing group, please contact us at cardiacsafety@dm.duke.edu

Read an online editorial by Dr. Philip Sager and Dr. Peter Kowey entitled," The Thorough QT Study: Is Its Demise on the Horizon?" Sager PT, Kowey P. The Thorough QT Study: Is Its Demise on the Horizon? Ann Noninvasive Electrocardiol 2014; Jan 8. doi: 10.1111/anec.12127.

Read in the Annals of Noninvasive Electrocardiology the IQ-CSRC design paper: THE IQ-CSRC Prospective Clinical Phase1 Study: "Can Early QT Assessment Using Exposure Response Analysis the Thorough QT Study"

The CSRC is currently working on additional papers:

  • Designs and statistical approaches to assess CV risk of new type 2 diabetes therapies in development (Final Review Process)
  • Practical Considerations for Assessing Cardiac Repolarization of Diabetes Drugs (Final Review Process)

If you have any ideas for future white papers, please contact us at cardiacsafety@mc.duke.edu.

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Upcoming Events and Important News
 

CSRC Anticoagulant-Induced Bleeding and Reversal Agents Thinktank Meeting- April 22, 2014

Click Here to view the Agenda

SEATS ARE FILLING FAST Register TODAY

White Oak Facility- FDA Headquarters

Logistics for the Meeting 

CSRC COPD Thinktank-  March 6, 2014

Synopsis of the meeting and the slides are now Available 
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