Concomitant Care Section
SPIRIT 2025 protocol guidance requires clarity about relevant concomitant care and interventions that are permitted or prohibited during the trial so treatment contrast and participant management can be understood. Requirements depend on the intervention, disease area, protocol, safety needs, sponsor, and jurisdiction. Do not imply that ordinary necessary care should be withheld merely to simplify a trial.
A Concomitant Care section states which non-trial treatments, medications, procedures, or other care are permitted, restricted, or prohibited during the trial.
Key details
Important caveats
Scope Boundary
Requirements depend on the intervention, disease area, protocol, safety needs, sponsor, and jurisdiction. Do not imply that ordinary necessary care should be withheld merely to simplify a trial.
Further guidance
Content
Identify important allowed, restricted, or prohibited concomitant care, explain material timing or eligibility conditions, and state how exceptions or clinically necessary treatment are handled when relevant.
Purpose
Clarify what participants may receive alongside the assigned intervention and what restrictions affect interpretation or safety.
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 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.