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This Wiki is for collaborative creation of QIBA materials and ongoing activities.
 
 
 
='''Quantitative Imaging Biomarkers Alliance (QIBA)'''=
 
='''Quantitative Imaging Biomarkers Alliance (QIBA)'''=
  
'''QIBA Mission: Improve the value and practicality of quantitative biomarkers by reducing variability across devices, patients and time.'''
+
'''QIBA Mission: Improve the value and practicality of quantitative imaging biomarkers by reducing variability across devices, sites, 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?]]
 
:* [[Media:Profiling.ppt|How Does QIBA Derive Profiles?]]
 
 
 
==QIBA Technical and Modaility Committee Rosters==
 
 
 
:* [[QIBA Modality Committees]]
 
 
 
 
 
QIBA currently has six active technical committees:
 
:* [[Perfusion, Diffusion and Flow-MRI tech ctte]]
 
:* [[fMRI tech ctte]]
 
:* [[FDG-PET tech ctte]]
 
:* [[CT Volumetry tech ctte]]
 
:* [[COPD-Asthma tech ctte]]
 
:* [[Ultrasound SWS tech ctte]]
 
  
==Related Efforts==
+
[[Image:QIBA_WIKI_BLURB.jpg|600px]]
  
:*[[Extended Pharma Imaging Group]]
 
  
QIBA also has one active Ad Hoc committee:
+
:* [[Profiles|'''QIBA Profiles''']] standardize methods to create biomarkers that meet a claimed performance (accurate and reproducible).
:*[[Committee on Open Image Archives]]
+
:* QIBA advances quantitative imaging in clinical trials and clinical practice.
 +
:* QIBA engages researchers, healthcare professionals and industry.
 +
:* '''[[QIBA Concepts]]''' & '''[[QIBA Overview]]''' & '''[[QIBA Collaborations]]'''
 +
:* '''[[Stakeholder Viewpoints|Stakeholder Benefits]]'''
  
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):
+
The navigation box to the left provides access to:
:*[[UPICT]]
+
* '''[[Profiles]]''' - biomarker specifications published by QIBA
 +
* '''[[Committees]]''' - developing biomarker Profiles and related work
 +
* '''[[Process]]es''' - guidance used by all Committees for developing Profiles and other QIBA work
 +
* '''[[QIBA Profile Conformance | Conformance]]''' - Self Attestation and Certification Services
 +
* '''[[QIBA News]]''' - Recent biomarker committee accomplishments, volunteer news items to share
 +
* '''[[Education]]''' - Introduction to QIBA, ''QIBA Newsletter'' archive, QIBA posters and presentations, and citations
 +
* '''[[Catalog|Resource Catalog]]''' - used for QIBA groundwork
 +
* '''[[About QIBA|About QIBA]]''' - an at-a-glance introduction and QIBA YouTube Playlist
 +
* '''[[QIBA Acknowledgments]]''' - Thank you to our volunteers!
  
==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==
+
==<font color=blue>'''QIBA NEWS'''<font>==
  
<<We should probably move these documents off the front page onto more topic oriented pages, and explain what they contain/what they are for>>
+
'''
 +
<font color="black">QIBA is Transitioning to QUIC!
  
*[[Media:QIBA task force report 11-3-11.pdf|QIBA Task Force Report]] ''August 2011''
+
'''
  
*[[Media:Guidance Standards for CTs.pdf|Guidance Standards for CTs]]
+
<font color="black">Over the past 16 years, RSNA QIBA has become recognized as a community of representatives of healthcare professionals, medical associations, government regulatory agencies, pharmaceutical and scanner industries, conducting numerous groundwork studies, working on metrology underpinnings, and developing consensus among experts in the field to create rigorous quantitative imaging Profiles.
*[[Media:Guidance biomarker qualification Aug 2011.pdf|Guidance biomarker qualification Aug 2011]]
+
Since its creation, QIBA’s work has developed and demonstrated the value and practicality of quantitative imaging biomarkers, nationally and internationally.  The next stage in this evolution is to expand RSNA’s quantitative imaging activities beyond development of Profiles, to work with stakeholders to focus on adoption and implementation in clinical trials and practice. The RSNA Board of Directors has created a Quantitative Imaging Committee (QUIC) to oversee this initiative. The QUIC will be comprised of radiologists, physicists, and other thought leaders from stakeholder groups, including industry, government, and partner organizations.
 +
Answers to the FAQ submitted by QIBA members are provided below.  
  
*[[Media:Guidance Standards for CTs.pdf|Guidance Standards for CTs]]
+
*[[Media:12.23.2023 QIBA_Accomplishments_TJH-2.PDF|QIBA Accomplishments Slides (Dr. Timothy J. Hall, PhD)]]
*[[Media:Guidance biomarker qualification Aug 2011.pdf|Guidance biomarker qualification Aug 2011]]
+
*[[Media:09.07.2023 LINK to FAQ PDF document2.PDF|FAQ PDF document]]
 +
*[[Media:QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf |QUIC Profile Endorsement Criteria]]
 +
*[[Media:QIBA Summary Abridged Version 21Dec2023-B.pdf |QIBA Summary – Abridged Version 21Dec2023]]
  
*[[Media:Why_QIBA_CT_specifics.pdf|"Why QIBA?" - Specifics associated with CT device and software manufacturers.]]
+
<font color="black">The Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket
*[[Media:Why_QIBA_PET-CT_specifics.pdf|"Why QIBA?" - Specifics associated with PET-CT device and software manufacturers.]]
+
Submissions Guidance for Industry and Food and Drug Administration (FDA) Staff was released on June 16, 2022, and can be accessed via the QIBA Education page: https://qibawiki.rsna.org/index.php/Education.  
*[[Media:Why_QIBA_MR_specifics.pdf|"Why QIBA?" - Specifics associated with MR device and software manufacturers.]]
 
  
*[[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]]
 
*[[Media:FREEMAN_FINAL_PROOF.pdf|QIBA posters from RSNA 2008 Annual Meeting]]
 
  
*[[Media:EU.2009.08.04 Guideline on Clinical evaluation of diagnostic agents.pdf|EMEA Guideline on Clinical Evaluation of Diagnostic Agents (2009.08.04)]]
+
<font color="black">QIBA Videos are now posted to RSNA's YouTube Channel!  https://tinyurl.com/QIBA-YouTube-Playlist. These videos have been created by our QIBA volunteers. Learn more about RSNA’s Quantitative Imaging Biomarkers Alliance® (QIBA), which unites researchers, health care professionals and industry to advance quantitative imaging and the use of imaging biomarkers in clinical trials and clinical practice. Please note: All QIBA promotional materials need to be reviewed and approved by RSNA.
*[[Media:EU.2009.08.04 Appendix 1 to the guideline.pdf|EMEA Guideline - Appendix 1 (2009.08.04)]]
+
:[[Image:QIBA-YouTube-image.png|300px]]
*[[Media:Oncology section.ppt|Oncology section from 2009 Imaging Biomarkers Roundtable]]
 
  
==Quantitative Imaging/Imaging Biomarkers and QIBA Meetings and Activities==
 
*[[Media:Biomarker Roadmap orig 7-20-10-11-01-10 reformatted for QIBA website.pdf|Biomarker Roadmap (11-01-2010 version)]]
 
  
*QI/IB Special Interest Session-
 
Imaging Biomarkers for Clinical Care and Research
 
Monday, November 29, 2010
 
'''[http://www2.rsna.org/re/QI_IB_Special_Interest_Session_RSNA_2010/Index.htm Presentations]'''
 
 
*QIBA Annual Meeting Presentations
 
May 24-25, 2011
 
Renaissance Arlington Capital View, Arlington VA
 
'''[http://www2.rsna.org/re/QIBA_Annual_Meeting_2011/ Presentations]'''
 
 
==2010-2012 NIBIB Contract Details==
 
 
*[[Media:HHSN268201000050C QIBA 18mo Semi-Annual Report-FINAL-08MAR2012.pdf|HHSN268201000050C QIBA (NIBIB) SemiAnnual (18-month) Progress Report]] ''February 2012''
 
*[[Media:HHSN268201000050C QIBA Annual Report 30SEP2011.pdf|HHSN268201000050C QIBA (NIBIB) Annual Progress Report]] ''September 2011''
 
*[[Media:HHSN268201000050C QIBA SemiAnnual Progress Report MARCH2011.pdf|HHSN268201000050C QIBA (NIBIB) SemiAnnual (6-month) Progress Report]] ''March 2011''
 
*[[Media:HHSN268201000050C QIBA Proposed Workplan 11-22-2010.pdf|HHSN268201000050C QIBA (NIBIB) Proposed Work Plan]] ''November 2010''
 
*[[Media:HHSN268201000050C QIBA Proposed Methology 10-11-2010.pdf|HHSN268201000050C QIBA (NIBIB) Proposed Methodology]] ''October 2010''
 
*[[Media:QIBA Round-1 Projects Overview.pdf|HHSN268201000050C QIBA (NIBIB) Round-1 Funded Projects Overview]]
 
*[[Media:NIBIB-QIBA -- Rnd-1 and 2 ProjectSummary--WIKI--Overview -- Updated 23Apr2012.xls|HHSN268201000050C QIBA (NIBIB) Round-1 and 2 Funded Project Overview]] ''23Apr2012''
 
  
 +
<font color="black">This wiki site is used primarily by the QIBA Committees.  For the more formal QIBA website, [http://www.rsna.org/qiba/ Click Here].
 
----
 
----
 
+
'''''Quantitative Imaging is a Work in Progress: read the [[Stakeholder Viewpoints|Stakeholder Benefits]]
NEW: '''[[How To's| "How To" help pages]]'''
 
 
 
*[[Media:Enabling E-alerts-20100504.pdf|Enabling E-alerts]]
 
 
 
*[[Media:Microsoft Word - WIKI PROTOCOL-v2.pdf|Posting Material]]
 
 
 
*[[Media:Wiki Help-History Overview2.pdf|History Search]]
 
 
 
'''''<This Wiki is a Work In Progress: read [[Help:Contents|Help]], create an [[Wiki Accounts|account]], contribute>'''''
 

Latest revision as of 22:14, 17 January 2024

Quantitative Imaging Biomarkers Alliance (QIBA)

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

QIBA WIKI BLURB.jpg



The navigation box to the left provides access to:

  • Profiles - biomarker specifications published by QIBA
  • Committees - developing biomarker Profiles and related work
  • Processes - guidance used by all Committees for developing Profiles and other QIBA work
  • Conformance - Self Attestation and Certification Services
  • QIBA News - Recent biomarker committee accomplishments, volunteer news items to share
  • Education - Introduction to QIBA, QIBA Newsletter archive, QIBA posters and presentations, and citations
  • Resource Catalog - used for QIBA groundwork
  • About QIBA - an at-a-glance introduction and QIBA YouTube Playlist
  • QIBA Acknowledgments - Thank you to our volunteers!



QIBA NEWS

QIBA is Transitioning to QUIC!

Over the past 16 years, RSNA QIBA has become recognized as a community of representatives of healthcare professionals, medical associations, government regulatory agencies, pharmaceutical and scanner industries, conducting numerous groundwork studies, working on metrology underpinnings, and developing consensus among experts in the field to create rigorous quantitative imaging Profiles. Since its creation, QIBA’s work has developed and demonstrated the value and practicality of quantitative imaging biomarkers, nationally and internationally. The next stage in this evolution is to expand RSNA’s quantitative imaging activities beyond development of Profiles, to work with stakeholders to focus on adoption and implementation in clinical trials and practice. The RSNA Board of Directors has created a Quantitative Imaging Committee (QUIC) to oversee this initiative. The QUIC will be comprised of radiologists, physicists, and other thought leaders from stakeholder groups, including industry, government, and partner organizations. Answers to the FAQ submitted by QIBA members are provided below.

The Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions Guidance for Industry and Food and Drug Administration (FDA) Staff was released on June 16, 2022, and can be accessed via the QIBA Education page: https://qibawiki.rsna.org/index.php/Education.


QIBA Videos are now posted to RSNA's YouTube Channel! https://tinyurl.com/QIBA-YouTube-Playlist. These videos have been created by our QIBA volunteers. Learn more about RSNA’s Quantitative Imaging Biomarkers Alliance® (QIBA), which unites researchers, health care professionals and industry to advance quantitative imaging and the use of imaging biomarkers in clinical trials and clinical practice. Please note: All QIBA promotional materials need to be reviewed and approved by RSNA.

QIBA-YouTube-image.png


This wiki site is used primarily by the QIBA Committees. For the more formal QIBA website, Click Here.


Quantitative Imaging is a Work in Progress: read the Stakeholder Benefits