Analysis Component: Variable of Interest (Endpoint)

[ASL-rmarshall]

The variable (or endpoint) to be obtained for each patient that is required to address the clinical question. The specification of the variable might include whether the patient experiences an intercurrent event. [E9(R1)]

Each variable of interest, or endpoint, is defined as a measure within a timeframe.

Measure

Each measure:

• Will be originally based on the result of one or more observations. Ideally, it should be possible to represent each original observation with a reference to a biomedical concept.
  • Observations may include results of targeted assessment (e.g. Findings-type results) and/or occurrences of events (including intercurrent events)
• May be based on one or more subsequent derivations
• May be affected by application of defined strategies for handling datapoints collected (or not) after the occurrence of one or more intercurrent events.

Timeframe

Each timeframe:

• Will usually have a label
• Will be expressed as either:
  • A windowed offset from a defined reference timepoint (“analysis timing”).
  • A reference to a scheduled time of collection of the original observation (e.g. a USDM Encounter for measures that will be analysed according to the visit at which they were collected, regardless of actual timing of assessment)

There may be one or more reference timepoints defined for any study (e.g. cross-over and cyclical studies will usually have multiple reference timepoints).

Each reference timepoint:

• Should be defined explicitly.
• Will usually be defined as the occurrence of a defined event.
• Should be represented with a reference to a biomedical concept.