A procedural template for the qualification of imaging as a biomarker, using volumetric CT as an example

Proliferation of data forthcoming from new ways to understand biology as well as the increasing interest in personalized treatments for smaller patient segments in turn requires new capabilities for the assessment of therapy response. While advances in imaging technology over the last decade may present opportunity to meet these needs, deployment of qualified imaging biomarkers lags the apparent technology capabilities allowed by these advances. The lack of consensus methods and qualification evidence needed for large-scale multi-center trials, and in turn the standardization that allows them, are widely acknowledged to be the limiting factor. The current fragmentation in imaging vendor offerings, coupled by the independent activities of individual biopharmaceutical companies and their CROs, may stand in the way of the greater opportunity were these efforts to be drawn together. An integrative activity wherein stakeholders collaborate on the methodology and activity of qualifying mature candidate biomarkers, while encouraging innovative development of new biomarkers with the promise for effective qualification as they mature on the one hand, and innovative therapy development with the ability to rely on cost-effective qualification of biomarkers on the other, may provide a more productive overall structure for the collective industries. This report updates the status of a cross-stakeholder effort to qualify imaging biomarkers, using Volumetric CT as an example that establishes a procedural template that can be applied to other biomarkers. A preliminary report of the Quantitative Imaging Biomarkers Alliance (QIBA) activity was presented at the DIA meeting in October 2008 [1]. The clinical context in Lung Cancer and a methodology for approaching the qualification of volumetric CT as a biomarker of response has been reported [2,3]. The long-term goal of the committee is to qualify the quantification of anatomical structures with x-ray computed tomography (CT) as biomarkers. The group selected solid tumors of the chest in subjects with lung cancer as its first case-in-point. The rationale for selecting lung cancer included the fact that the systems engineering analysis, groundwork, profile claims documents, and roadmaps for biomarker qualification in this specific setting can serve as a general paradigm for eventually qualifying other imaging biomarkers as well. This report addresses the question of how this procedural template is applied and how it may be used for other quantitative imaging biomarkers as a methodology.