Few imaging biomarkers have reached everyday clinical use. The problem isn't a lack of candidates. There is an enormous number of potential imaging biomarkers.
QIBA's job is to identify a biomarker that is sufficiently robust, proven and understood to be ready for QIBA to help bridge that last mile.
QIBA has limited resources to spread across the groundwork and profiling work of the Biomarker Committees so they must be selected carefully.
The Steering Committee evaluates the proposals on a number of criteria and considerations, and votes on whether to approve.
If approved, a new Biomarker Committee is typically formed, although the work could be assigned to an existing Biomarker Committee.
- Addresses a significant medical biomarker need with a likely considerable impact on public health, and addresses a critical gap in the biomarkers qualification/validation process.
- Will likely result in significant improvement in the development, approval, or delivery of care to patients.
- 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.
- Leverages preexisting resources (e.g., intellectual capital, personnel, facilities, specimens, reagents, data) wherever possible; warrants access to RSNA resources and support.
- 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.