General principles for evaluation of new interventional technologies and devices. Technology Assessment Committee.

INTERVENTIONAL therapies and devices have become increasingly accepted in recent years. It is the purpose of the Technology Assessment Committee of the Society of Interventional Radiology (SIR) to propose guidelines for the scientific evaluation of new technology. This article is a statement of general principles of research and is intended to be the background for subsequent standards produced by the Technology Assessment Committee, such as the reporting standards for clinical evaluation of new peripheral arterial revascularization devices that follow this article. While these principles are necessary to evaluate new technologies and devices, they also represent an optimal way to evaluate current technologies. The goal of these guidelines is to create reliable evidence of device and technique effectiveness (1–5).