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.
- To facilitate focused pragmatic research that will inform regulatory processes with regard to cardiac safety.
- 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.
- To develop knowledge and strategies intended to improve the evaluative sciences in relation to cardiac safety and product development.
- To coordinate “think tanks” and other programs and public forums for open discussion and updates on topics in cardiovascular safety pertaining to drug and device development.
- To establish infrastructure and operational processes with the following components:
- Transparent processes that promote dialogue
- Input from all primary stakeholders (e.g., FDA, industry, academics, NIH)
- Involve all consortium contributors (those private partners that contribute annually to fund the overarching consortium activities) in the decision-making and project-development process
- Leverage resources and expertise from multiple public and private partners
- Create an open and efficient mechanism for submitting potential projects and their objective evaluation
- Facilitate and, where appropriate, orchestrate mechanisms for continuance of ongoing cardiac-safety research programs
- Involve broader public or patient groups in the process as appropriate
- Encourage cross-sector interaction and problem-solving
- Leverage previously conducted and ongoing clinical studies, research infrastructure, and databases
- Preserve proprietary interests