Platform trial overview — Platform trial

Master question

Define the shared research question, disease setting and objectives of the continuing platform.

Protocol and governance

Establish the master protocol, arm-specific documents, independent oversight, approvals and prospective registration.

Define cohorts and comparisons

Specify cohort and arm eligibility, estimands, active epochs and comparison-specific control sets.

Recruit

Enroll participants under the applicable protocol version and document all eligible active options.

Allocate among eligible arms

Allocate among eligible active arms according to the current prespecified rule.

Monitor

Apply safety and efficacy monitoring with controlled interim access and documented review authority.

Add or stop arms

Open or close recruitment using the approved lifecycle rules while preserving participant follow-up.

Analyze comparisons

Use comparison-specific populations, calendar handling, multiplicity and inference; assess any nonconcurrent borrowing separately.

Report

Report arm lifecycles, available comparisons, eligible controls and protocol versions alongside comparison results.

Platform trial 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.