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Quantitative Imaging Biomarkers Alliance (QIBA)

QIBA Mission: Improve the value and practicality of quantitative biomarkers by reducing variability across devices, patients and time.

QIBA is an initiative to advance quantitative imaging and the use of imaging biomarkers in clinical trials and clinical practice by engaging researchers, healthcare professionals and industry . This involves:

• collaborating to identify needs, barriers, and solutions to develop and test consistent, reliable, valid, and achievable quantitative imaging results across imaging platforms, clinical sites, and time.
• accelerating the development and adoption of hardware and software standards needed to achieve accurate and reproducible quantitative results from imaging methods.

QIBA develops Profile specifications and coordinates the necessary research and qualification groundwork.

• What Are Profiles and Protocols?
• How Does QIBA Derive Profiles?

QIBA Biomarker and Coordinating Committee Rosters

• Archive for previously known QIBA Modality Committees

QIBA currently has ten active biomarker committees:

• Perfusion, Diffusion and Flow-MRI Biomarker Ctte (Roster)
• fMRI Biomarker Ctte (Roster)
• PDFF Biomarker Ctte (proposed) (Roster)
• MRE Biomarker Ctte (Roster)
• PET Amyloid Biomarker Ctte (Roster)
• FDG-PET Biomarker Ctte (Roster)
• SPECT Biomarker Ctte (Roster)
• CT Volumetry Biomarker Ctte (Roster)
• Lung Density Biomarker Ctte (Roster)
• Ultrasound SWS Biomarker Ctte (Roster)
• AIUM/QIBA Ultrasound Volume Blood Flow Biomarker Ctte (Roster)

Related Efforts

• QIBA Newsletter: https://www.rsna.org/QIBA_Newsletter.aspx

Welcome to the QIBA Newsletter, an e-newsletter dedicated to providing news and information from the Quantitative Imaging Biomarkers Alliance (QIBA), formed by RSNA in 2007 to unite researchers, healthcare professionals, and industry stakeholders in the advancement of quantitative imaging and the use of biomarkers in clinical trials and practice. The QIBA Newsletter offers articles, web links and tools, as well as updates from technical committees and information about how you can participate in QIBA activities.

• Pharma Imaging Network for Therapeutics and Diagnostics (PINTAD)

QIBA also has one active Ad Hoc committee:

• Committee on Open Image Archives

QIBA also has one collaboration sub-committee (task force) with the RSNA Radiology Informatics Committee:

• QIBA/RIC ctte

QIBA is also collaborating with UPICT (Uniform Protocols for Imaging in Clinical Trials):

• UPICT

Trial Implementation Documents

• QIBA Protocol/Profile Implementation Feedback Process

Public Comment Documents

Documents published by QIBA for public comment can be found here:

• Work Product for Review

Documents

• QIBA Biomarker Selection Criteria
• QIBA Committee Structure
• Imaging Biomarker Roadmap for QIBA Profiles
• Proposed Categories for QIBA Project Proposal Submissions
• Definitions for QIBA Protocols and Profiles

Claim Guidance and Profile Template Documents

Claim Guidance

• QIBA Profile Claim Guidance November 2015
• Minimum Requirements Claim Testing October 2014
• Explanation of changes to claim format July 2014

Profile Templates

• QIBA Profile Template - Word Version (coming soon) (Process Committee Version) November 2015
• QIBA Profile Template - PDF Version for reference (Process Committee Version) November 2015

Please note: Wiki conversion from .docx to .doc caused "alignment tabs" to become "traditional tabs." PDF version of original layout posted for reference.

• QIBA Profile Stage Descriptions 21Feb2013

QIBA Resources

• QIBA Fact Sheet October 2015

• QIBA Governance Structure September 2015

• QIBA Patent Disclosure Policy March 2015
• QIBA Task Force Report August 2011

• Guidance Standards for CTs
• Guidance biomarker qualification Aug 2011

• Guidance Standards for CTs
• Guidance biomarker qualification Aug 2011

• "Why QIBA?" - Specifics associated with CT device and software manufacturers.
• "Why QIBA?" - Specifics associated with PET-CT device and software manufacturers.
• "Why QIBA?" - Specifics associated with MR device and software manufacturers.

Posters

• QIBA posters from RSNA 2014 Annual Meeting
• QIBA posters from RSNA 2013 Annual Meeting
• QIBA posters from RSNA 2012 Annual Meeting
• QIBA posters and plenary session presentation from RSNA 2011 Annual Meeting
• QIBA and UPICT posters from RSNA 2010 Annual Meeting
• QIBA and UPICT posters from RSNA 2009 Annual Meeting
• QIBA posters from RSNA 2008 Annual Meeting

Guidelines

• Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

• EMEA Guideline on Clinical Evaluation of Diagnostic Agents (2009.08.04)
• EMEA Guideline - Appendix 1 (2009.08.04)
• Oncology section from 2009 Imaging Biomarkers Roundtable

Quantitative Imaging/Imaging Biomarkers and QIBA Meetings and Activities

• QIBA in the Literature Citations

• Biomarker Roadmap (11-01-2010 version)

• QI/IB Special Interest Session-

Imaging Biomarkers for Clinical Care and Research Monday, November 29, 2010 Presentations

• QIBA Annual Meeting Presentations

May 21-22, 2014 Hyatt Regency Crystal City, Arlington, VA [1]

2010-2012 NIBIB Contract Details

• HHSN268201000050C QIBA (NIBIB) Final Report March 2013
• HHSN268201000050C QIBA (NIBIB) 2nd Annual Progress Report October 2012
• HHSN268201000050C QIBA (NIBIB) SemiAnnual (18-month) Progress Report February 2012
• HHSN268201000050C QIBA (NIBIB) 1st Annual Progress Report September 2011
• HHSN268201000050C QIBA (NIBIB) SemiAnnual (6-month) Progress Report March 2011
• HHSN268201000050C QIBA (NIBIB) Proposed Work Plan November 2010
• HHSN268201000050C QIBA (NIBIB) Proposed Methodology October 2010
• HHSN268201000050C QIBA (NIBIB) Round-1 Funded Projects Overview
• HHSN268201000050C QIBA (NIBIB) Round-1 and 2 Funded Project Overview 23Apr2012

2013-2015 NIBIB Contract Details

• HHSN268201300071C QIBA (NIBIB) SemiAnnual (18-Month) Progress Report March 2015
• HHSN268201300071C QIBA (NIBIB) 1st Annual Progress Report October 2014
• HHSN268201300071C QIBA (NIBIB) SemiAnnual (6-Month) Progress Report March 2014
• HHSN268201300071C QIBA (NIBIB) Proposed Work Plan November 2013
• HHSN268201300071C QIBA (NIBIB) Proposed Methodology October 2013

2015-2017 NIBIB Contract Details

• HHSN268201500021C QIBA (NIBIB) Proposed Methodology October 2015

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