Platform simulations and sample-size scenarios

Evaluate changing platform operating characteristics

Assess changing arms, eligibility, accrual and calendar trends jointly. Shared controls and any borrowing affect the operating characteristics of individual comparisons and claim families.

Flow diagram

Platform simulations and sample-size scenariosF1.S1Define candidate platformconfigurationsF1.S2Vary treatment and time scenariosF1.S3Simulate eligibility and operationsF1.S4Assess claim-specific performanceF1.S5Document reproducibility andlimitationsF1.N1Platform simulation scenariosScenarioArm lifecycleCalendartrendControl poolClaim familyPerformancetargetsStableplatformChangingcontrol riskArm entry andexitDelayedoutcomesF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowPlatform simulations and sample-sizescenariosF1.S999 End flowEnd flow

Steps

Define candidate platform configurations

Specify cohorts, arm-entry patterns, controls and allocation rules.

Vary treatment and time scenarios

Include null/effective arms, changing standard care and calendar drift.

Simulate eligibility and operations

Model overlapping comparisons, accrual, delayed outcomes and arm closure.

Assess claim-specific performance

Evaluate error, power, bias, coverage and resource use across comparisons.

Document reproducibility and limitations

Record code versions, Monte Carlo precision and scenario coverage.

Platform simulations and sample-size scenarios

End flow

Tables and supporting information

Platform simulation scenarios

Platform simulation scenariosScenarioArm lifecycleCalendartrendControl poolClaim familyPerformancetargetsStableplatformChangingcontrol riskArm entry andexitDelayedoutcomes

Evaluate the actual platform rules rather than copying a fixed multi-arm power calculation.

Assumptions and rationale

Changing eligibility and calendar composition can affect borrowing, control comparability and operating characteristics.

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.

Sources