Analysis Components

[ASL-rmarshall]

To support automation of analyses, it is necessary to provide (or derive) specifications of all of the components that would be used to design and implement all the analyses required for a study. These components include, but are not limited to:

• Aggregation calculations used to summarize or compare data values across subjects (draft proposed definition of “Analysis Concept” – see Analysis Component: Population-level Summary (Estimator) #7 )
• Within-subject calculations used to produce result values that are needed to support eventual aggregation (previous definition of “Derivation Concept”).

The ICH E9(R1) estimands framework provides a good basis for the identification of the necessary components and will therefore be used as the starting point for the determination of analysis components. There will be a separate discussion topic for each component:

• Analysis Component: Estimand #3
• Analysis Component: Population (Analysis Set) #4
• Analysis Component: Variable of Interest (Endpoint) #5
• Analysis Component: Intercurrent Event #6
• Analysis Component: Population-level Summary (Estimator) #7
• Analysis Component: Reporting Event #8