QIBA Profile Stages

Over time QIBA revises draft Profiles, collects information, and becomes increasingly confident of its ability to achieve the stated claim. However QIBA does not want to withhold Profiles until they are "perfect".

Depending on how they intend to use the Profile, some users will find Profiles valuable even with only modest QIBA confidence, while others will count on achieving the claims exactly. Profile stages are intended to communicate the stage of maturity or confidence clearly and allow users to make their own choice about what meets their needs.

Briefly:

Stage 1 Public Comment	The Biomarker Committee experts have drafted the profile and believe it is practical and expect it to achieve the claimed performance.
Stage 2 Consensus	The wider community has read the profile and believe it to be practical and expect it to achieve the claimed performance
Stage 3 Technically Confirmed	Site(s) have performed the profile and found it to be practical and expect it to achieve the claimed performance
Stage 4 Claim Confirmed	Site(s) have performed the profile and found it achieved the claimed performance
Stage 5 Clinically Confirmed	Many sites have performed the profile and demonstrated the claimed performance is widely achievable.

The Criteria are checklist items/metrics/Rules-Of-Thumb the Biomarker Committee considers before publishing a Profile as having reached that stage.

Stage 1: Public Comment

Meaning:

• The Profile is ready for public comment.
• The Profile claim and requirements will likely change based on comments.
• The Profile is believed to be practical.
• The Profile is expected to achieve the claimed performance.
• The Biomarker Committee (BC) finds that the Profile describes the key factors that affect the claim and has proposed recommended procedures that address each/most of the factors.

Criteria:

• All open issues have been clearly listed
• Most open issues have candidate resolutions drafted into the Profile
• Some groundwork projects may be underway
• All major solution components and Profile details are complete enough to implement
• For each actor in the Profile, it is clear what is required for a system or organization to claim conformance
• Each activity in the Profile has a justification based on literature data, phantom studies, or TC consensus
• Conformance requirements appear sufficient to accomplish the Claim of the Profile

Stage 2: Consensus (Publicly Reviewed)

Meaning:

• The Profile is ready for Feasibility testing.
• The Profile claim and requirements may change based on Feasibility testing results.
• The Profile is widely believed to be practical.
• The Profile is expected to achieve the claimed performance.

Criteria:

• All public comments have been addressed
• All open issues necessary for conformant deployment have been resolved
• Few, if any, groundwork projects remain active
• All recommended procedures have been tested in one or more groundwork project(s) or referenced studies. (Reasonable deviations from Profile details may exist.)

Stage 3: Technically Confirmed

Meaning:

• The Profile is ready for Claim testing.
• The Profile claim and requirements may change based on Claim testing results.
• The Profile has been found to be practical.
• The Profile is expected to achieve the claimed performance.

Criteria:

• All Profile procedures and details have been implemented on at least two vendor platforms and at two or more sites and found to be clear and not burdensome/impractical
• An example of each Profile actor have demonstrated conformance
• The BC will generally coordinate with sites/vendors to achieve this stage as it does with groundwork projects
• Consider what documentation would be important. Think about how site conformance might be audited.

Stage 4: Claim Confirmed

Meaning:

• The Profile is ready for Clinical testing.
• The Profile claim and requirements may change (rarely) based on Clinical testing results.
• The Profile has been found to be practical.
• The Profile has been found to achieve the claimed performance.

Criteria: Groundwork projects are complete

• All Profile procedures and details have been implemented on at least two vendor platforms and at two or more sites
• All Profile procedures and details have been tested in the field as described in the Profile
• Profile results under experimental conditions are consistent with the Claim.
• Some claims (for patient-independent metrics) might be confirmable with phantoms/DROs (and may be part of assessment procedures) but likely measurement of performance in phantoms/DRO is not sufficient by itself to declare patient oriented claims to be confirmed.
• Q. how does all this play into conformance testing?
• QIBA Registry role? Mountain of data aggregation?

Stage 5: Clinically Confirmed

The meaning and criteria of Stage 5 - Clinically Confirmed are still under discussion.

QIBA won't DO this stage but may be a facilitator/enabler to get there.

Meaning:

• The Profile claim and requirements are not longer expected to change.
• The Profile is proven to be practical.
• The Profile is proven to achieve the claimed performance.

Criteria:

• All recommended procedures and Profile details have been implemented by multiple systems or sites
• All recommended procedures and Profile details have been tested in the field as described in the Profile
• The Profile Claim has been achieved in clinical conditions
• Additional proposed criteria that will be discussed:

• The degree of statistical certainty has been documented and exceeds …
• Some level of Clinical validation has been demonstrated
• The Profile has been implemented in a human research study

See Also

• QIBA Profile Stage Descriptions February 2016
• How to use QIBA Profiles