The Trial Steering Committee (TSC) is responsible for oversight of the trial in order to safeguard the interests of trial patients. The TSC is comprised of a 75% majority of independent and lay members, as well as the Chief Investigator, representatives of Principal Investigators, a representative of the sponsor, the health economist and senior trial statistician. The committee provides advice to the Chief Investigator, UCL Comprehensive Clinical Trials Unit, the funder and sponsor on all aspects of the trial through its Independent Chair. The remit of the TSC is to oversee study conduct and advise the TMG.
The Trial Management Group (TMG) co-ordinates and strategically manages the trial.
The Independent Data Monitoring Committee (IDMC) is the only oversight body that has access to un-blinded accumulating comparative data. The IDMC is responsible for safeguarding the interests of trial patients, monitoring the accumulating data and making recommendations to the TSC on whether the trial should continue as planned.