Trial conclusions and reporting
RECRUITMENT
At each scheduled analysis, the SNAP trial analytic team will prepare an unblinded report for the data safety and monitoring committee. If stopping rules are satisfied, the data safety and monitoring committee will make recommendations to the global trial steering committee on the public disclosure of results and/or the removal of interventions within particular subdomains.Note that if a stopping rule for superiority is met for a given subdomain, then the intention is to cease randomisation to all relevant interventions. All future trial participants may be deterministically allocated to the superior intervention, or a different intervention determined by the treating clinician, until a new intervention is added to the subdomain. If the treating clinician determines the intervention, then the choice will be recorded in the trial database. If non-inferiority is demonstrated at a scheduled analysis, then recruitment into that subdomain may continue in order to seek a conclusion of superiority, based on prespecified rules in the relevant domain-specific appendix, and the recommendation from the data safety and monitoring committee and global trial steering committee. Further safety outcomes are reviewed by the data safety and monitoring committee at each scheduled analysis who, within their charter, may request a continuation of enrolment, even if a non-inferiority or superiority decision criteria have been met, in order to collect more information on the safety of intervention(s).