Exclusion of enrolled participants in randomised controlled trials: what to do with ineligible participants?

摘要

Post-randomisation exclusions in randomised controlled trials are common and may include participants identified as not meeting trial eligibility criteria after randomisation. We report how a decision might be reached and reported on, to include or exclude these participants. We illustrate using a motivating scenario from the BREATHE trial (Trial registration ClinicalTrials.gov, {"type":"clinical-trial","attrs":{"text":"NCT02426112","term_id":"NCT02426112"}}NCT02426112) evaluating azithromycin for the treatment of chronic lung disease in people aged 6–19 years with HIV in Zimbabwe and Malawi.