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

Content Provider	IEEE Xplore Digital Library
Author	Buckler, A.J.
Copyright Year	2009
Description	Author affiliation: Buckler Biomedical LLC, MRVimage Inc. (Buckler, A.J.)
Abstract	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.
Starting Page	1
Ending Page	7
File Size	813863
Page Count	7
File Format	PDF
ISBN	9781424451463
ISSN	15505219
DOI	10.1109/AIPR.2009.5466324
Language	English
Publisher	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Publisher Date	2009-10-14
Publisher Place	USA
Access Restriction	Subscribed
Rights Holder	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Subject Keyword	Qualifications Biomarkers Computed tomography Medical treatment Lungs Cancer Image segmentation Large-scale systems Standardization Collaboration
Content Type	Text
Resource Type	Article

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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