Platform comparison analysis specification
Specify comparisons across calendar epochs
Account for shared-control dependence, time effects, adaptations and multiplicity appropriate to each claim. Report the control pool and active epochs so readers can reconstruct the comparison.
Flow diagram
Steps
Define each primary comparison
Link the analysis population, estimand and eligible control pool.
Specify time and borrowing model
Address calendar epochs and any justified nonconcurrent information.
Account for shared information
Preserve dependence from shared controls and adaptation or selection.
Apply comparison-specific inference
Use the planned multiplicity, estimator and interval strategy.
Assess robustness and report epochs
Compare concurrent-only and other prespecified alternatives and retain protocol versions.
Platform comparison analysis specification
End flow
Tables and supporting information
Platform analysis specification
Report each comparison with its eligible epochs and control definition.
Assumptions and rationale
A pooled control group is not automatically valid across arms or epochs; temporal drift and changing eligibility can bias contrasts.
Method and protocol evidence
Attach the protocol, methodological sources and versioned software specification supporting these decisions. Record citations and provenance; do not enter participant identifiers.