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Mission and 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 with regard to cardiac safety
  2. To develop expert consensus around common nomenclature, standards, and key definitions, and to draft white papers in challenging areas, describing what is known and unknown, and proposing paths forward to address such knowledge gaps
  3. To develop knowledge and strategies intended to improve the evaluative sciences in relation to cardiac safety and product development
  4. To coordinate think tanks, scientific meetings, and public forums for open discussion and updates on topics in cardiovascular safety pertaining to drug and device development
  5. To establish infrastructure and operational processes with the following components:
    • Transparent processes that promote dialogue, cross-sector interaction, and problem solving
    • Inclusion of broader public or patient groups in the process as appropriate
    • Input from all primary stakeholders (e.g., FDA, industry, academia, NIH)
    • Involvement from all consortium contributors (i.e., private partners who help fund the consortium's activities) in the decision-making and project development process
    • Resources and expertise from multiple public and private partners
    • Open and efficient method for submitting potential projects and their objective evaluation
    • Facilitation and, where appropriate, orchestration of mechanisms for continuance of ongoing cardiac safety research programs
    • Utilization of previously conducted and ongoing clinical studies, research infrastructure, and databases
    • Preservation of proprietary interests