Quantitative Imaging Biomarker Alliance (QIBA): Protocols and Profiles

The practice of medicine is becoming more of a science and less of an art, and imaging science needs to keep pace in order to remain relevant. Treating physicians need and expect objective, reproducible, ideally quantitative, results from diagnostic tests, but the medical community continues to be challenged by the lack of objective, qualified imaging biomarkers useful for disease prevention, detection, and treatment. Recent advances in imaging technology present opportunities to meet these needs, but the deployment of qualified quantitative imaging biomarkers (QIBs) lags behind the technological advances. It is widely acknowledged that the primary factor limiting large-scale deployment of imaging biomarkers is the lack of standardization on how to implement them across each of the stakeholders. The current differentiation in imaging vendor products, as well as the independent activities of clinicians, individual biopharmaceutical companies, and related clinical research organizations, stands in the way of the greater opportunity that would exist if these efforts were drawn together. The formation of the Quantitative Imaging Biomarkers Alliance (QIBA) from the Radiological Society of North America (RSNA) provides a productive structure for all participants in the imaging chain to integrate activities and allow stakeholders to collaborate on the methodology to obtain QIBs. The QIBA process provides a path in the innovative development of new, promising, and objective imaging biomarkers (which benefits the imaging device industry), and innovative therapies facilitated by cost-effective, qualified biomarkers (which benefits care providers, the pharmaceutical industry, and other healthcare product providers). This chapter provides a history of QIBA from its inception, ending in a present state and challenges moving forward.