Multiple-endpoint testing
Endpoint family → success criteria → testing strategy → decision rules
Flow diagram
Steps
Define confirmatory endpoint family
Identify endpoints, comparisons, time points and analysis opportunities included in error control.
Joint success criteria
Specify all-primary versus any-primary success and role of secondary claims.
Primary endpoint A
Define the first primary hypothesis.
Primary endpoint B
Define another primary hypothesis; add or remove as needed.
Error control and testing procedure
Specify the actual procedure, ordering and any alpha recycling; do not infer it from arrows.
Secondary endpoint family
Specify entry conditions for secondary testing.
Decision and reporting rules
Document adjusted inference and interpretation when gates are not passed.
Tables and supporting information
Testing strategy specification
No default alpha allocation or gatekeeping procedure is assumed.
Multiplicity assumptions
Specify error criterion and dependence assumptions of the chosen procedure.
Testing rationale and evidence
Record clinical prioritization and method references.