Trial oversight
EVENTS, EVENT, RECRUITMENT
A Trial Steering Group (TSG), comprised of the lead investigators, the data manager, internal quality manager, and the trial statisticians, will meet at least once a month to discuss trial operations. Interim reports will be prepared for the independent Data Safety and Monitoring Board (DSMB), comprised of an epidemiologist, statistician, paediatrician, physician, and a clinical pharmacologist, to address the recruitment of participants, vaccine uptake, and event rates in both arms of the trial. The DSMB will review these data to decide whether any additional sample size calculations are required, and whether to recommend an extension of the trial to allow more outcome events to accumulate. The board will advise the TSG on changes that may be required in the trial’s operations to achieve its objectives.A Scientific Advisory Group, comprised of the lead investigators, independent experts in clinical trials and community interventions, representatives from the Directorate of Public Health, and policy experts, will also review the processes and progress of the trial once every 6 months and provide feedback.