New precompetitive paradigms: focus on cardiac safety.

For the last several years, there have been a decreasing number of new innovative medical therapies approved for use in the United States despite an increasing expenditure on medical product development. This situation has been compounded by an increasing awareness of safety issues arising from these approved drugs as well as frommedical devices that have resulted in medical product discontinuations or recalls. With the heightened awareness of medical product safety issues and, in particular, cardiovascular safety, the Cardiac Safety Research Consortium (CSRC) was formed in 2006 to formulate paths forward to address these public heath concerns. The CSRC is a public-private partnership consisting of members from academia, industry, and various governmental agencies such as the US Food and Drug Administration (FDA) and Health Canada, which have organized as a group with the goal of identifying mechanisms to improve cardiovascular safety of medical products, while at the same time, encouraging more effective and more efficient medical product development. The Cardiac Safety Research Consortium has adopted this approach from the FDA's Critical Path Initiative (www.fda.gov/oc/initiatives/criti calpath) that was set forth to foster the evaluative sciences behind both safety and efficacy surrounding medical product development. This is critical because, as the safety hurdles for new approvals and marketed products have been raised, medical product development timelines have increased with the potential to impede innovation and limit the availability of needed therapies for patients. The primary goal of the CSRC is to bring together diverse organizations to collaborate on primary research that will address specific questions regarding cardiovascular safety that directly impact drug and