Global assessment variables are typically implemented as what kind of scale?

• A. A scale of ordered categorical ratings reflecting overall state or change.
• B. A strict numeric biomarker value.
• C. They are identical to primary endpoints.
• D. They are only used in exploratory studies.

Answer: (A)

Global assessment variables are captured as an ordered set of categories that reflect the overall state or change in a patient’s condition. This means they’re measured on an ordinal scale (for example, from very much improved to very much worse), not as a precise numeric biomarker value. Such scales capture overall impression rather than exact measurements, and they’re commonly used as secondary or exploratory endpoints rather than being identical to primary endpoints. They’re also not limited to exploratory studies; clinician- or patient-rated global scales, like CGI-S or CGI-I, are standard in many trials and require standardized rater training to ensure consistency.