Feasibility endpoints and progression
Define criteria for study progression
Feasibility endpoints answer whether and how to proceed. Prespecify progression criteria and their denominators; treatment efficacy is generally not the primary decision criterion in a feasibility pilot.
Flow diagram
Steps
Define feasibility uncertainties
Identify decisions needed before a later definitive study.
Feasibility endpoints
Specify recruitment, retention, adherence, acceptability and data completeness.
Prespecify progression criteria
Define proceed, amend or stop rules with context and rationale.
Define progression review
Specify responsible decision-makers and qualitative/contextual evidence.
Link decisions to the later study
Explain which design changes each criterion can inform.
Feasibility endpoints and progression
End flow
Tables and supporting information
Progression criteria
Set justified criteria; do not use a nonsignificant efficacy result as evidence to stop.
Feasibility endpoint register
Efficacy endpoints may be exploratory, not definitive claims.