Houn F, Bright R A, Bushar H F, Croft B Y, Finder C A, Gohagan J K, Jennings R J, Keegan P, Kessler L G, Kramer B S, Martynec L O, Robinowitz M, Sacks W M, Schultz D G, Wagner R F
U.S. Food and Drug Administration, Rockville, MD 20852-0001, USA.
Acad Radiol. 2000 Sep;7(9):684-92. doi: 10.1016/s1076-6332(00)80524-3.
Bringing a new imaging technology to market is a complex process. Beyond conceptualization and proof of concept, obtaining U.S. Food and Drug Administration (FDA) approval for clinical use depends on the documented experimental establishment of safety and efficacy. In turn, safety and efficacy are evaluated in the context of the intended use of the technology. The purpose of this study was to examine a conceptual framework for technology development and evaluation, focusing on new breast imaging technologies as a highly visible and current case in point.
The FDA views technology development in terms of a preclinical and four clinical phases of assessment. With a concept of research and development as a learning model, this phased-assessment concept of regulatory review against intended use was integrated with a five-level version of a hierarchy-of-efficacy framework for evaluating imaging technologies. Study design and analysis issues are presented in this context, as are approaches to supporting expanded clinical indications and new intended uses after a new technology is marketed.
Breast imaging technologies may be intended for use as replacements for standard-of-care technologies, as adjuncts, or as complementary technologies. Study designs must be appropriate to establish claims of superiority or equivalence to the standard for the intended use. Screening technologies are ultimately judged on their demonstrated effectiveness in decreasing cause-specific mortality through early detection, but they may be brought to market for other uses on the basis of lesser standards of efficacy (eg, sensitivity, specificity, positive and negative predictive value, and stage of disease detected).
将一项新的成像技术推向市场是一个复杂的过程。除了概念化和概念验证之外，获得美国食品药品监督管理局（FDA）的临床使用批准取决于安全和有效性的实验记录。反过来，安全和有效性是在该技术预期用途的背景下进行评估的。本研究的目的是检验技术开发和评估的概念框架，重点关注新的乳腺成像技术这一高度显著且具有时效性的典型案例。
FDA从临床前和四个临床评估阶段的角度看待技术开发。以研究和开发的学习模型概念为基础，这种针对预期用途的分阶段评估的监管审查概念与用于评估成像技术的五级效能层次框架相结合。在此背景下介绍了研究设计和分析问题，以及在新技术上市后支持扩大临床适应症和新预期用途的方法。
乳腺成像技术可能旨在替代标准护理技术、作为辅助手段或作为补充技术使用。研究设计必须适合确立在预期用途方面优于或等同于标准的主张。筛查技术最终根据其在通过早期检测降低特定病因死亡率方面所证明的有效性来评判，但它们也可能基于较低的效能标准（例如，敏感性、特异性、阳性和阴性预测值以及检测到的疾病阶段）用于其他用途而推向市场。
