Global Assessment Variable

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A Global Assessment Variable is a variable that integrates all objective variables and the investigator's overall impression about a test subject's state or change of it.



References

2022

A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject. (ICH E9)

1998

If objective variables are considered by the investigator when making a global assessment, then those objective variables should be considered as additional primary, or at least important secondary, variables.

 Global assessment of usefulness integrates components of both benefit and risk and reflects the decision making process of the treating physician, who must weigh benefit and risk in making product use decisions. A problem with global usefulness variables is that their use could in some cases lead to the result of two products being declared equivalent despite having very different profiles of beneficial and adverse effects. For example, judging the global usefulness of a treatment as equivalent or superior to an alternative may mask the fact that it has little or no efficacy but fewer adverse effects. Therefore it is not advisable to use a global usefulness variable as a primary variable. If global usefulness is specified as primary, it is important to consider specific efficacy and safety outcomes separately as additional primary variables.