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  • QIBA Processes

  • The QIBA Process to Achieve Standards-based Quantitative Imaging Biomarkers

    Optimal patient care, clinical research and new therapy development require efficient and valid methods to quantify the results of biomedical imaging. QIBA accelerates the development and adoption of hardware and software standards needed to achieve accurate and reproducible quantitative results from imaging methods.

    Stakeholders from the clinical research community, imaging equipment manufacturers, the pharmaceutical industry, government and medical informatics companies collaborate through QIBA 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.

    The Three Steps of the QIBA Process

    1.   Define the clinical question and proposed biomarker to be addressed.
    2.   Production of Protocol and Profile
    3. Profile Validation, Promulgation and Maintenance 

      For more process details please see the full Description of QIBA Process.

    The QIBA Approach

    QIBA follows a defined, coordinated process for solutions development and adoption.

    1.   Identify Sources of Error and Variation in Quantitative Results from Imaging Methods. Stakeholders work to identify problems leading to error or variability in quantitative results from imaging methods.
    2.   Specify Potential Solutions. Stakeholders identify potential strategies and infrastructure for error mitigation and collaborate on development of hardware, software, and protocol solutions, documenting them in the form of QIBA profiles.
    3.   Test Solutions. Vendors and researchers implement QIBA solutions to assess their feasibility and efficacy.
    4.   Promulgate Solutions. Validated solutions are disseminated and implemented through vendor adoption, research integration and clinical education.

    For more information, please see the QIBA Fact Sheet for reference.

    Criteria for Identifying Biomarker Opportunities

  • Transformational

    • Addresses a significant medical biomarker need with a likely considerable impact on public health, consistent with the future vision as delineated in the Imaging Biomarker roadmap
    • Addresses a critical gap in the biomarkers qualification/validation process and/or may otherwise transform the process of how biomarkers are developed, approved, and applied in the future

    Translational

    Will likely result significant improvement the development, approval, or delivery care patients. The following characteristics are desirable:

    • Potential for biomarker to reduce size and increase objectivity of metrics in multicenter studies.
    • Opportunity for biomarker to move into clinical care
    • Preliminary data on biomarker performance and reproducibility are documented in the literature
    • Biomarker is currently in use as proof of mechanism/proof of concept (POM/POC) in a multi-center therapy development setting.

    Feasible

    An idea or program whose end goals can likely be achieved in a specific timeframe and that has a reasonable prospect of producing the expected outcomes; ideal programs are those which could result in regulatory qualification of a biomarker in three years.

    Practical

    Leverages preexisting resources (e.g., intellectual capital, personnel, facilities, specimens, reagents, data) wherever possible; warrants access to RSNA resources and support.

    Collaborative

    Would uniquely benefit from the multi-stakeholder composition and approach of QIBA and could be feasibly executed under its policies e.g. resulting in extension or adoption in product development among hardware, software, or imaging agents. The biomarker has the support of the stakeholder community with the organizational impetus to sustain continued efforts.