The Governing CommitteesTrial Management Group (TMG)
The TMG comprises the key figures involved in the day to day running of ARROW including the principal investigators and other experts with detailed knowledge of advances in the field. The TMG reviews and advises on the overall strategy of ARROW. It meets regularly by teleconference or face-to-face meetings.
The TMG advises the TSC on the strategic direction of ARROW and recommends changes to take account of operational issues or developments in the field. The TMG's responsibilities include:
- reviewing the overall progress of the ARROW trial.
- reviewing relevant information from other sources (e.g. other related anti-HIV drug initiatives) and, in the light of these, suggesting any changes to ARROW.
MRC Guidelines on Good Clinical Practice in Clinical Trials require each MRC trial to be supervised by a Trial Steering Committee (TSC). The Principal Investigators are required to make an annual report to the MRC, to be endorsed by the TSC. The majority of members of the TSC are independent (not involved with the running of the trial).
The function of an MRC TSC is to monitor and supervise the progress of the trial towards its interim and overall objectives, focussing on adherence to the trial protocol and Good Clinical Practice, patient safety and the consideration of new information.
Data Monitoring Committee (DMC)
An independent (not involved with the running of the trial) DMC meets at least annually, prior to TSC meetings.
The DMC makes recommendations concerning the conduct (and continuation) of the trial to the TSC. The DMC monitors the safety of the trial, reviews confidential unblinded data, initiates and assesses interim analyses and considers the findings from other relevant studies with the assistance of the Principal Investigators. The recommendations of the DMC are circulated and approved by all DMC members, then forwarded to the Trial Steering Committee and Site Ethics Committees.
Endpoint Review Committee
All trial endpoints, i.e. all new AIDS defining events and deaths are reviewed by independent doctors to ensure all events meet the correct clinical criteria.
Here is a downloadable presentation of how the ARROW committees work.