Medical imaging has seen substantial and rapid technical advances during the past decade, including advances in image acquisition devices, processing and analysis software, and agents to enhance specificity. Traditionally, medical imaging has defined anatomy, but increasingly newer, more advanced, imaging technologies provide biochemical and physiologic information based on both static and dynamic modalities. These advanced technologies are important not only for detecting disease but for characterizing and assessing change of disease with time or therapy. Because of the rapidity of these advances, research to determine the utility of quantitative imaging in either clinical research or clinical practice has not had time to mature. Methods to appropriately develop, assess, regulate, and reimburse must be established for these advanced technologies. Efficient and methodical processes that meet the needs of stakeholders in the biomedical research community, therapeutics developers, and health care delivery enterprises will ultimately benefit individual patients. To help address this, the authors formed a collaborative program-the Quantitative Imaging Biomarker Alliance. This program draws from the very successful precedent set by the Integrating the Healthcare Enterprise effort but is adapted to the needs of imaging science. Strategic guidance supporting the development, qualification, and deployment of quantitative imaging biomarkers will lead to improved standardization of imaging tests, proof of imaging test performance, and greater use of imaging to predict the biologic behavior of tissue and monitor therapy response. These, in turn, confer value to corporate stakeholders, providing incentives to bring new and innovative products to market.

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Quantitative imaging biomarkers could speed the development of new treatments for unmet medical needs and improve routine clinical care. However, it is not clear how the various regulatory and nonregulatory (eg, reimbursement) processes (often referred to as pathways) relate, nor is it clear which data need to be collected to support these different pathways most effi ciently, given the timeand cost-intensive nature of doing so. The purpose of this article is to describe current thinking regarding these pathways emerging from diverse stakeholders interested and active in the defi nition, validation, and qualifi cation of quantitative imaging biomarkers and to propose processes to facilitate the development and use of quantitative imaging biomarkers. A fl exible framework is described that may be adapted for each imaging application, providing mechanisms that can be used to develop, assess, and evaluate relevant biomarkers. From this framework, processes can be mapped that would be applicable to both imaging product development and to quantitative imaging biomarker development aimed at increasing the effectiveness and availability of quantitative imaging.