Abstract
The drug development industry is faced with increasing costs and decreasing success rates. New ways to understand biology as well as the increasing interest in personalized treatments for smaller patient segments requires new capabilities for the rapid assessment of treatment responses. Deployment of qualified imaging biomarkers lags apparent technology capabilities. The lack of consensus methods and qualification evidence needed for large-scale multi-center trials, as well as the standardization that allows them, are widely acknowledged to be the limiting factors. The current fragmentation in imaging vendor offerings, coupled with the independent activities of individual biopharmaceutical companies and their contract research organizations (CROs), may stand in the way of the greater opportunity were these efforts to be drawn together. A preliminary report, "Volumetric CT: a potential biomarker of response," of the Quantitative Imaging Biomarkers Alliance (QIBA) activity was presented at the Medical Imaging Continuum: Path Forward for Advancing the Uses of Medical Imaging in the Development of New Biopharmaceutical Products meeting of the Extended Pharmaceutical Research and Manufacturers of America (PhRMA) Imaging Group sponsored by the Drug Information Agency (DIA) in October 2008. The clinical context in Lung Cancer and a methodology for approaching the qualification of volumetric CT as a biomarker has since been reported [Acad. Radiol. 17, 100-106, 107-115 (2010)]. This report reviews the effort to collect and utilize publicly available data sets to provide a transparent environment in which to pursue the qualification activities in such a way as to allow independent peer review and verification of results. This article focuses specifically on our role as stewards of image sets for developing new tools.
Highlights
The development of public resources and open source tools for imaging as a biomarker using X-ray computed tomography (CT) was re-invigorated by the National Cancer Institute (NCI), National Institute of Biomedical Engineering and Bioengineering (NIBIB), Food and Drug Administration (FDA) and National Institute of Standards and Technology (NIST) in 2005, which included collaboration with the Radiological Society of North America (RSNA) [12,14±17]
The Quantitative Imaging Biomarker Alliance (QIBA) initiative has explored a number of issues and opportunities to improve research and development of volumetric CT therapy assessment methods
Whether considered from the vantage point of providing an objective basis on which to evaluate the relative performance of different candidate methods, or to allow individual groups access to larger data sets than they would otherwise be able to afford individually, or as a primary driver in the effort to harness the strength of current and new technology towards clinically relevant problems, there is a recurrent theme of the importance of public data resources
Summary
X-ray computed tomography (CT) is a three dimensional imaging technique that can noninvasively portray internal anatomy and pathological masses. For an individual patient in an ordinary medical setting, being prescribed a marketed treatment regimen that has been established as sufficiently safe and effective in large populations is analogous to starting a personal clinical trial. This is because even the best treatment regimens fail in a some portion of patients with the disease, and even relatively safe therapies cause serious side effects in some people. For tumors that can be modeled as spheres, these changes correspond to changes of about 66% and + 73%, respectively Because these thresholds are relatively large and can take a long time for some patients to cross them, there is a need for more sensitive methods for making assessments of response with confidence. The need to test the hypothesis again seems urgent in part because a number of investigators have shown that the measurements of whole tumor volumes can be more precise [9] and sensitive [10±13] than the measurement of the corresponding LDs
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