About Us

Safety is a critical component of medical product development and approval.  In particular, cardiac safety has received intense focus with several high profile issues including market withdrawals.  This has stimulated debate over the best way in which to measure efficacy while ensuring the protection of the public health.  At the center of this debate is the balance between efficacy and safety.  Importantly, rapid advances in therapeutic medical product development have yet to reach full potential, in part due to limits in our ability to understand and quantitate therapeutic balance. 

Unfortunately the evaluative sciences surrounding medical product approval have not kept pace with our fundamental understanding of disease. Societal investment in research and development to improve the approval process has been lacking in contrast to the large investment, both private and public, in basic research and specific product advances. In order to improve the ability of regulatory agencies to promote and protect the public health there needs to be a fundamental investment in the evaluative sciences.  Specifically, the scientific basis of our understanding of medical product safety needs to be enhanced and integrated with refined measurements of efficacy.  An investment in the evaluative sciences will provide more precise scientifically-based information enabling health care professionals and patients to appropriately assess risk and benefits.

The Critical Path Initiative has been developed by the FDA to address many of these issues by establishing greater collaboration between regulators, academics, physicians, and scientists from industry.  The spirit of this collaboration is intended to create opportunities by sharing existing knowledge and data that will facilitate the process of enhancing, refining, and ultimately improving the process used to evaluate new medical products.  A central tenet to Critical Path is a focus on the evaluative science of the approval process, including both efficacy and safety measures.

The Cardiac Safety Research Consortium (CSRC) is a first step in bringing together key constituencies to focus on cardiac safety issues during the new medical product development process.  By utilizing the principals of the Critical Path Initiative, the CSRC will focus on improving the evaluative sciences specifically in relation to cardiac safety.

This consortium will address cardiac safety in cardiovascular and non-cardiovascular medical products. While the initial focus will be on the proarrhythmic risk of products, the intent of this collaboration is to develop evaluative tools, standards, validated tests and cardiovascular biomarkers related to broader aspects of cardiac safety including, but not limited to arrhythmia, thrombosis, myocardial infarction, and heart failure.

1. To facilitate focused pragmatic research  that will  inform regulatory processes
2. To create common nomenclature, 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 a specific attention to the use and qualification of biomarkers for the assessment of cardiac safety
4. To establish infrastructure and operational processes with the following components: