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U.S. Department of Health and Human Services

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Cardiac Safety Research Consortium (CSRC)

Public Health Context: 

Cardiovascular disease is the leading cause of death in the United States, accounting for over one quarter of all deaths every year (CDC, National Vital Statistics for 2007).  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 a MOU 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 post-market periods.
 

Mission & Program Objectives:

To advance scientific knowledge on cardiac safety for new and existing medical products by building a collaborative environment based upon the principles of the FDA’s Critical Path Initiative as well as other public health priorities.

Key Objectives:

  1. To facilitate focused pragmatic research that will inform regulatory processes.
  2. To create common nomenclature and standards, and draft regulatory guidance documents for cardiac safety evaluation.
  3. To develop knowledge and improve the evaluative sciences in relation to cardiac safety and product development with specific attention to the use and qualification of biomarkers for the assessment of cardiac safety.

Accomplishments as of August 2010:

  • Think Tank Incubators launched for:
    • Safety of Atrial Fibrillation Ablation Initiative (SAFARI)
    • Dual Anti-Platelet Therapy (DAPT) Study
    • CSRC-HESI (Health and Environmental Sciences Institute) preclinical cardiac safety evaluation
  • Ten "Thorough QT" studies (Placebo and Moxifloxacin control arms only) released from FDA ECG warehouse by data owners (Merck, GSK, Lilly) for use in CSRC-approved research projects.  Four studies are currently available accounting for a total of 25,000 individual records.
  • CSRC TransRadial Education And Training (TREAT) Think Tank (June 23, 2010 at White Oak).
  • CSRC Cardiac Troponin evaluation white paper meeting (June 28, 2010 at White Oak).
     

Partners:

Government:

U.S. Food and Drug Administration

Industry:

Abbott Laboratories
Amgen, Inc.
Anilab
AstraZeneca International
Biogen Idec
Cardiocore
Cardionet
Daiichi Sankyo, Inc.
Duck Flats Pharma
Eli Lilly and Company
eResearch
GlaxoSmithKline
Johnson & Johnson, LLC
Merck and Co., Inc.
Medifacts International
Medpace
Monebo
NewCardio, Inc.
OBS Medical
Pfizer Inc.
Quintiles
Roche Palo Alto, LLC
sanofi-aventis U.S., Inc.

Other:

Duke University

RELEVANT PUBLICATIONS:

Al-Khatib, Sana M., Hugh Calkins, Benjamin C. Eloff, Douglas L. Packer, Kenneth A. Ellenbogen, et al. "Planning the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a Collaborative Pan-Stakeholder Critical Path Registry Model: A Cardiac Safety Research Consortium 'Incubator' Think Tank." American Heart Journal. 159.1 (2010): 17-24. Print

Finkle, John, Daniel Bloomfield, Kathleen Uhl, Wendy Sanhai, Norman Stockbridge, et al. "New Precompetitive Paradigms: Focus on Cardiac Safety." American Heart Journal. 157.5 (2009)" 825-26. Print.

Min, Sherene S., J. Rick Turner, Adel Nada, Tara L. DiMino, Ivo Hynie, et al. "Evaluation of Ventricular Arrhythmias in Early Clinical Pharmacology Trials and Potential Consequences for Later Development." American Heart Journal. 159.5 (2010): 716-29. Print.

Piccini, Jonathan P., David J. Whellan, Brian R. Berridge, John K. Finkle, Syril D. Petit, et al. "Current Challenges in the Evaluation of Cardiac Safety During Drug Development: Translational Medicine Meets the Critical Path Initiative." American Heart Journal. 158.3 (2009): 317-26. Print.

Rock, Edwin P., John Finkle, Howard J. Fingert, Brain P. Booth, Christine E. Garnett, et al. "Assessing Proarrhythmic Potential of Drugs when Optimal Studies are Infeasible." American Heart Journal. 157.5 (2009): 827-36. Print.

Sanhai, Wendy R., Benjamin C. Eloff, and Robert H. Christenson. "Cardiac Muscle and Disease." Clinical Chemistry: Theory, Analysis, and Correlation (5th Edition). Ed. Lawrence Kaplan and Amadeo J. Pesce. St. Louis: Mosby, 2010. 677-90. Print.

Sanhai, Wendy R., Norman Stockbridge, Robert P. Fiorentino, Takahiro Uchida, and Kathleen Uhl. "Drug Eluting Stents and the Critical Path Initiative: Evolving Paradigms for Safety Evaluation." Drug Discovery Today: Technologies. 4.2 (2007): 43-46. Print.

Agarwal, Ritu, Wendy R. Sanhai, et al. "Value Assessment in a Public Private Partnership: The Balanced Scorecard and the FDA’s Cardiac Safety Research Consortium." (Submitted to American Journal of Public Health, 2010)