Intervention Modification and Discontinuation Section
SPIRIT 2025 item 15b asks protocols for criteria that guide modification or discontinuation of assigned interventions or comparators. Criteria are intervention- and trial-specific and may be constrained by regulation, product information, safety monitoring, and clinical judgment; avoid generic thresholds presented as universal.
An Intervention Modification and Discontinuation section states when and why an assigned intervention or comparator may be changed, paused, reduced, or stopped.
Key details
Important caveats
Scope Boundary
Criteria are intervention- and trial-specific and may be constrained by regulation, product information, safety monitoring, and clinical judgment; avoid generic thresholds presented as universal.
Further guidance
Content
Describe the criteria and decision process for dose changes, temporary interruption, permanent discontinuation, participant-requested changes, or other relevant modifications.
Purpose
Pre-specify intervention-change criteria so participant safety and treatment consistency are handled transparently.
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.
- SPIRIT 2025 statement: updated guideline for protocols of randomised trials (opens in a new tab)BMJ / SPIRIT-CONSORT Group · Primary SPIRIT 2025 reporting guideline for the minimum content of randomized-trial protocols, including amendments and protocol transparency.
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (opens in a new tab)BMJ / SPIRIT-CONSORT Group · Primary SPIRIT 2025 explanation and elaboration for trial protocols, including trial monitoring and data monitoring committee roles and reporting structure.