Dose-finding study overview — Dose-escalation and dose-finding study

Dose question

Define the toxicity, activity or other criterion that the dose-selection decision should address.

Protocol and approvals

Prespecify permissible regimens, evaluability, safety constraints, review authority and analysis; obtain required approvals.

Register

Register the interventional study prospectively with the registry name, identifier and initial protocol version.

Enroll cohort

Enroll the permitted cohort under current safety and evaluability rules and document holds or replacements.

Administer dose

Administer only the protocol-authorized dose or regimen and document modifications and actual receipt.

Assess toxicity and activity

Assess prespecified toxicity and activity within defined windows, retaining delayed and incomplete observations.

Review escalation decision

Provide verified data to the authorized committee and document how the reviewed rule informs its decision.

Expand or stop

Apply protocol-permitted expansion, continuation, hold or stopping rules and retain follow-up.

Recommend dose

Document the evidence and uncertainty for a selected regimen, or the conclusion that no dose is acceptable.

Dose-finding study overview

End flow

Protocol and decision register

Record the protocol, approvals and registration where applicable. Preserve planned decisions and amendments separately from results.

Protocol and rationale evidence

Attach the dated protocol, approvals and amendments. A clinical trial registry publicly records the trial plan, such as ClinicalTrials.gov or an eligible WHO primary registry such as ISRCTN. Record the registry name, identifier and registration date before first enrollment. WHO ICTRP is a search platform, not itself a registry. Registration does not imply randomization.