Feasibility study overview — Pilot or feasibility trial

Feasibility question

Identify the uncertainties that prevent a definitive trial, such as recruitment, retention or delivery.

Protocol and approvals

Prespecify feasibility outcomes, progression criteria, review authority and approvals.

Register

If the pilot assigns a health intervention, register prospectively as an interventional study; record registry and identifier.

Recruit and deliver

Pilot eligibility, consent, assignment if used and delivery under the intended trial procedures.

Measure feasibility

Estimate recruitment, retention, adherence and measurement feasibility with defined denominators and uncertainty.

Assess progression criteria

Apply prespecified progression criteria with operational, qualitative and safety context.

Refine later study

Document whether to proceed, amend or stop and which design changes are needed.

Report

Report feasibility objectives and decisions; use the randomized pilot extension when randomization was used.

Feasibility 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.