Committee Procedures

Organizational Structure

• Steering Committee is established by RSNA
  • Responsible for managing the strategic direction, processes and inftrastructure for QIBA and overall oversight of the QIBA activities and committees.
• Modality Coordinating Committees are established by the Steering Committee
  • Responsible for coordinating Biomarker Committees within their modality.
• Biomarker Committees are proposed by the Modality Coordinating Committee and approved by the Steering Committee
  • Responsible for drafting Profiles and protocols, and coordinating associated groundwork and field testing.
  • Task Forces are established by the Biomarker Committee as needed to:
    • Plan and carry out specific groundwork projects.
    • Write Profiles and/or protocols.

Committee Membership

• Steering Committee members are appointed by the RSNA.
• Modality Coordinating Committee members can be self-nominated, but must have participated in at least 50% of teleconferences during the previous 12 months. Retention of modality committee membership will require participation in at least 50% of teleconferences. Participation in teleconferences will be assessed on a rolling basis every 6 months. New members can be added to Modality Committees every 6 months based on their participation in a tleast 50% of TC calls during the previous 12 months. The minimum level of teleconference participation is established by the Steering Committee and can be changed by the Steering Committee if it sees fit to do so.
• Biomarker Committees are "open" committees
  • "Open" committees are open to anyone with a relevant interest.
  • Committee Co-Chairs can direct RSNA staff to add names to the roster.
  • Task Forces are typically volunteer subsets of their parent Biomarker Committee
• Rosters for each Biomarker Committee are posted on the Wiki.

Decision Making

• Goal: group consensus and imaging community input and endorsement on major decisions.
• Recorded vote required for procedural decisions
  • Key group decisions, such as public dissemination of documents, are subject to approval by Modality Committees
  • Majority of participating members passes
  • Negative votes must be discussed
• For recorded votes:
  • Meeting attendee names and vote outcome will be recorded in minutes.

Committee Functions

• Steering Committee:
  • Manage Relationships and Optimize Communications
    • Create a collaborative, multidisciplinary environment that fosters communication among imaging groups and other medical disciplines involved in the research, approval, and use of quantitative imaging biomarkers (QIBs)
    • Educate stakeholders about Profiles
    • Provide content and administrative support of web sites/ Wikis
    • Support face-to-face meetings
  • Determine and Manage Process
    • Develop ways of working, organizing, etc. across the various entities.
    • Utilize principles from imaging science to undertand clinical image information content and utility.
    • Adopt a statistically rigorous framework for determining and reducing sources of variation.
    • Lay out a process for certification of compliance tot he Profile and how this relates to regulatory pathways.
  • Coordinate Quantitative Imaging Biomarker Evaluation
    • Evaluate clinical needs for biomarkers for each therapeutic area.
    • Develop and maintain public infrastructure for biomarker-specific data and associated metadata.
    • Oversee inputs and works-in-progress of teams; mantain scorecard.
  • Influence Regulatory Pathways
    • Clarify and optimize pathway for imaging biomarkers to become widely available.
    • Develop process guidance with regulatory agencies inclusive of drug development and patient care.
    • Plan and hold workshops with FDA.
  • Explore Self-funded Models to Maintain Forward Progress
    • Define what size adn scope of offort is sustainable and over what period of time.

• Modality Committees (Most of the this work is delegated to Biomarker Committees)
  • Coordinate the Biomarker Committees in their modality
    • Maintain a balance of work and resources .
    • Identifying synergies where possible in groundwork, authoring and testing.
    • Prioritizing funding proposals submitted to the Steering Committee
    • Proposing established biomarkers that are ready for industrialization to the Steering Committee
  • Based on the clinical context and needs, identify and prioritize biomarkers to pursue ("work item selection").
    • Propose
    • Evaluate
    • Approve
  • For each selected biomarker:
    • Profile development
      • Production
      • UPICT protocol
      • Provisional goals
      • Draft and Review text
      • Collect and Resolve Public Comment
    • Real world validation ("Field-testing")
      • Approve
      • Trial implementation
      • Collect and Resolve feedback
    • Publication
      • Prepare
      • Approve
      • Publish
  • Reference Object(s) and Support Material(s) for Experimentation and Quality Control (QC)
    • Phantoms traceable to recognized physical standards
    • Digital Reference Objects (DRO)
    • Definition of comprehensive QC program, including data analysis and reporting requirements
  • Identification of Technical Characteristics and Standards
    • Assess intrinsic scanner variablity, minimum detectable change, and limits of quantification.
    • Identification and assessment of intra- and inter-reader bias and variance across scanners and centers.
  • Clinical Performance Groundwork
    • Develop a process map detailing steps to meet regulatory and payer requirements.
    • Perform studies necessary if literature does not fully support the process map. These may be retrospective or prospective (e.g.,assessment of intra- and inter-reader sensitivity and specificity for specific clinical utility).
  • Clinical Efficacy Groundwork
    • Characterize value in clinical trials
    • Characterize value in clinical practice
    • Compare new biomarker and 'accepted-as-standard' method
    • Develop/ merge databases from trials in support of achieving statistical power
  • FDA Qualification
    • Request letter
    • Briefing document(s)
    • Full data package
  • Device Compliance
    • Determine compliance testing methods
      • Acquisition
      • Post-procesing
    • Device version tracking

See Also

• QIBA Committees