Question of interest (QOI) and context of use (COU)
QOI is the specific question a modeling analysis answers; COU is how the result will be used. Stating both before the analysis keeps the claim within what the data support.
Definition
- Question of interest (QOI): the specific question that a modeling or data analysis is meant to answer, written down before the method is chosen.
- Context of use (COU): how the result will be used, that is, what decision it will inform and what it will not be used for.
Both terms are used in model-informed drug development (MIDD) to say how much credibility a model needs: the same model can be adequate for one context of use and inadequate for another.
Why state them first
A question fixed after seeing the results can be tuned to whatever the data happen to show. A context of use also limits the claim in advance. An analysis meant to prioritize further research does not have to meet the standard of one that sets a dose, and it must not be read as one.
How the site uses them
Every analysis on this site states its QOI and COU near the top. For example, the early tumor change and survival analysis has research prioritization as its context of use, and says that treatment switching, dosing and surrogate qualification are not assessed. The mosunetuzumab reimplementation limits itself to model reimplementation and regimen comparison for research and learning.
Frequently asked questions
Is the context of use the same as the indication of a drug?
No. The context of use is the role of the analysis result in a decision, for example prioritizing a follow-up study. The indication is the clinical use of a drug.
Why is the question stated before the analysis?
So that the question is not adjusted to the results. A prespecified question and a prespecified context of use limit what the analysis may claim.