Dose-design simulations and assumptions
Evaluate operating characteristics across scenarios
Simulate the full enrollment and decision process under plausible dose-response shapes, delays and accrual. Assess overdosing, selection, sample size and failure to identify an acceptable regimen, not only correct-dose selection.
Flow diagram
Steps
Define candidate design and targets
Specify toxicity target, available levels and selection objective.
Define dose-response scenarios
Include safe, toxic, steep, flat and delayed-outcome scenarios as relevant.
Specify operational simulation
Model accrual, follow-up, missing assessments and stopping rules.
Assess operating characteristics
Evaluate selection probability, allocation above target, sample size and trial duration.
Document reproducibility and review
Record code, seeds, replication precision and acceptance rationale.
Dose-design simulations and assumptions
End flow
Tables and supporting information
Dose-design simulation scenarios
Attach independently generated simulation evidence; the editor does not run dose algorithms.
Assumptions and rationale
Good average performance can conceal unsafe scenarios; assess safety and selection across plausible extremes.
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.