Trial Governance

The EARNEST programme is funded by the EDCTP with contributions from European national funding agencies and institutions. The JCRC, Uganda is acting as the EDCTP project co-ordinator for the EARNEST programme.

The EARNEST trial is sponsored by the MRC, UK and is co-ordinated by the MRC clinical trials unit.

International Trial Management Group

An international trial management group (TMG) oversees the day-to-day conduct of the trial. This comprises the principal and key investigators from each site as well as members of the MRC CTU and other international collaborators. This group is in communication on a day-to-day basis through the EARNEST website which has a secure discussion group area for the TMG. The group holds a regular teleconference at approximately monthly intervals at which sites will summarise progress and challenges and bring up for discussion any difficulties, as well as discuss and decide matters of general importance for the trial. This group is chaired by the trial chief investigator and all decisions regarding the overall running of the trial will be made in this forum with the exception of matters of fundamental importance to the viability of the trial or that require major changes to the protocol. These will be referred to the Trial Steering Committee (TSC). The TMG will have a face-to-face meeting held approximately once per year around the time of an international conference or other meeting held in Africa.

Trial Steering Committee

The trial steering committee (TSC) provides overall supervision for the trial. This consists of an independent Chair, the trial chief investigator, the EARNEST project coordinator (individual responsible for the trial to EDCTP, the funding organisation), two additional principal investigators from participating African sites, a community representative from Africa, and two independent HIV-experienced clinicians, drawn from African sites not participating in the trial or from participating European partner countries. Representatives of pharmaceutical companies that have donated drug and/or provided other support of the study are invited to attend TSC meetings as observers.

Independent Data Monitoring Committee

The independent data monitoring committee (IDMC) comprises two HIV clinical trials research-experienced clinicians, and a statistician, none of whom have direct involvement with the study. The IDMC will report to the TSC. The IDMC will meet when the first 120 patients have reached 24 weeks of follow-up, and then periodically throughout the trial.

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