Governance

The DART trial was funded by the UK Medical Research Council (MRC), the UK Government's Department for International Development (DFID) and the Rockefeller Foundation. The MRC acted as the Sponsor of DART.

Thr trial was co-ordinated by the MRC Clinical Trials Unit in London which was directly responsible to the MRC as sponsor of the trial. The Rockefeller Foundation funded the trial site in Zimbabwe and the Joint Clinical Research Center (JCRC) site in Uganda, the teams at these sites also reported to the Rockefeller Foundation.

MRC clinical trials are required to comply with the MRC Guidelines for Good Clinical Practice in Clinical Trials (1998) which require structures and committees to be set up to monitor progress of the trial. The structures set up for DART are shown below.

Click here for a downloadable presentation of how the DART committees work.

International Co-ordinating Group (ICG)

The ICG reviewed and advised on the overall strategy of DART. It met regularly by teleconference or face-to-face meetings.

The ICG advised the Trial Steering Committee (TSC) on the strategic direction of DART and recommend changes to take account of operational issues or developments in the field. The ICG's responsibilities included:

• Reviewing the overall progress of the DART trial.
• Reviewing relevant information from other sources, other related antiretroviral (ARV) drug initiatives for example, and suggesting any changes to the DART team in light of this.

Trial Steering Committee (TSC)

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 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, good clinical practice, patient safety and the consideration of new information.

Data and Safety Monitoring Committee (DSMC)

An independent DSMC met at least annually, prior to TSC meetings.

The DSMC made recommendations concerning the conduct and continuation of the trial to the TSC. The DSMC monitored the trial, reviewed confidential unblinded data, initiated and assessed interim analyses and considered the findings from other relevant studies with the assistance of the Principal Investigators. The recommendations of the DSMC were circulated and approved by all DSMC members, then forwarded to the TSC and Site Ethics Committees.

Regulatory and Ethical Review

The DART protocol and amendments were approved by regulatory and ethics review bodies in Uganda and Zimbabwe. Additionally, the protocol was reviewed by an ethics committee in the UK.

The Ugandan and Zimbabwe ethics boards received annual reports of the progress of the trial as well as the reports from the DSMC.