Cardiac Safety

Drug safety has become one of the most hotly debated topics in therapeutic drug development and approval. In particular, cardiac safety has been a focus, with several high-profile withdrawals from the market stimulating debate over the best way to measure efficacy while ensuring protection of the public health.

At the center of this debate is the balance between efficacy and safety. Unfortunately, the evaluative sciences surrounding drug approval have not kept pace with our fundamental understanding of disease. Rapid advances in therapeutic drug development have yet to reach full potential, in part due to limits in our ability to understand the balance of safety and efficacy.

For the FDA to meet its mission and for the promise of better health based on science to be realized, there needs to be a fundamental investment in the evaluative sciences. The Critical Path Initiative was developed by the FDA to combat many of these issues. The collaboration is designed to build opportunities by sharing existing knowledge and data that will facilitate the creation of enabling standards, ultimately improving drug development and approval. A central tenant to the Critical Path Initiative is a focus on the evaluative science of the drug 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 drug development process. Using the principals of the Critical Path Initiative, the CSRC will focus on improving the evaluative sciences, specifically in relation to cardiac safety.