Trial management group
A FEAST Trial Management Group (TMG) was appointed and made responsible for overseeing the progress of the trial. The day-to-day management of the trial was coordinated by the Trial Management Team (TMT) based at the Clinical Trials Facility, a department within KEMRI-Wellcome Trust Research Programme. Kilifi, Kenya.
Trial Steering Committee
The trial was managed by a Trial Steering Committee (TSC) with an independent chairperson (Professor Elizabeth Molyneux OBE), a majority of independent members and one Principal Investigator or key investigator from each of the sites, from Imperial College, and from MRC CTU.
Independent Data Monitoring Committee
An independent Data Monitoring Committee (IDMC) was set up to review data on enrolment, safety, adherence to randomised strategies, efficacy and safety at regular intervals and in strict confidence. At least 3 interim reviews (after 300, 600 and 900 patients) were conducted during the trial.
The IDMC was to report to the Trial Steering Committee (TSC) and to the Ethics Committee in each country, if, in their view, the data provided proof beyond reasonable doubt that one of the allocated strategies was better than its comparator in terms of the primary outcome. The TSC would then decide whether to amend (which may include removing one of the intervention arms) or stop the trial before the end of the planned follow-up. If a decision was made to continue, the IDMC would advise on the frequency of future reviews of the data on the basis of accrual and event rates. The IDMC would make recommendations to the FEAST Trial Steering Committee as to the continuation of the trial.
Endpoint Review Committee
An Endpoint Review Committee reviewed clinical data (blinded to allocation) and determined the validity of potential endpoints. It had an independent Chair and included Principal Investigators from each site as well as other independent clinicians. No member reviewed endpoints from their own site. A terms of reference document for the Endpoint Review Committee was drawn up.