Interim Analysis and Stopping Rules Section
CONSORT 2025 treats interim analyses and stopping guidelines as reportable trial methods when they were planned or used, because early looks at accumulating data can affect interpretation and trial conduct. Many studies have no interim analysis or formal stopping rule. Use the section only when the design includes these procedures or the reporting standard requires an explicit statement.
An Interim Analysis and Stopping Rules section explains any planned interim analyses and the criteria or governance used to stop or modify a trial early.
Key details
Important caveats
Scope Boundary
Many studies have no interim analysis or formal stopping rule. Use the section only when the design includes these procedures or the reporting standard requires an explicit statement.
Further guidance
Content
Describe the timing, statistical or safety criteria, and decision process without implying that every trial needs interim analysis; also report material deviations from the planned process when applicable.
Purpose
State whether interim analyses were planned, what decision rules or boundaries applied, and who had authority to review accumulating data or recommend stopping when relevant.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- CONSORT 2025 statement: updated guideline for reporting randomised trials (opens in a new tab)BMJ / CONSORT Group · Primary 2025 CONSORT reporting guideline for randomized trials, including participant flow and trial-registration information.