Objective Performance Goals, Clinical Trial Design Suggested for Endovascular Treatments of CLI
December 3, 2009—In the Journal of Vascular Surgery (JVS), Michael S. Conte, MD, et al discuss the role of Objective Performance Criteria and Goals (OPC and OPGs) in the US Food and Drug Administration’s (FDA) premarket assessment of devices for the treatment of critical limb ischemia (CLI) (2009;50:1459–1461). The article notes that unique statutory requirements, such as the "least burdensome mandate," have allowed the FDA to employ nonconcurrent controls in its evaluation of prospective therapies. The use of OPC and OPGs for the premarket evaluation of cardiovascular devices has become established as an alternative to randomized, controlled trials. According to the authors, these single-armed comparisons may facilitate rapid entry of novel devices to the market. Unlike randomized, controlled trials, they do not establish superiority or noninferiority of the examined therapy, and study populations must be carefully inspected to ensure validity of comparisons to historical controls.
