The MDP Trial Steering Committee (TSC) is charged with the general oversight of the Phase III clinical trial MDP301, in the first instance. Review is expected to include accrual, retention, the quality of data and care provided to participants, data systems and management, evidence gathered through monitoring of the conduct with respect to the protocol, and analyses of blinded data during the course of the trial, with particular emphasis on safety data. The MDP TSC is responsible for all scientific decisions in accordance with the trial protocol and in light of reports or recommendations from any of the trial committees or groups (including the Data Monitoring Committee and Programme Management Board/Executive).

To achieve this, the TSC:

1. meets (either face-to-face or by teleconference) about twice each year
2. reviews the documentation and quality assurance and control systems in place to ensure validity of data prior to the trial commencing
3. agrees the information to be submitted to the committee at each meeting during the trial in order to monitor and supervise the progress and management, such as:
   1. reports from the PMB Executive on accrual and retention and strategies to address any shortfalls
   2. reports from the PMB Executive on findings from site monitoring visits which reflect adherence to the protocol and quality assurance and control systems and strategies to address any critical or major findings
   3. blinded safety data (extent and frequency)
   4. information to be provided to the participants during the trial for the purposes of disseminating information or safety concerns
   5. relevant information from other sources (e.g. other related trials)
4. identifies any information from the categories in 3 that should be submitted for more urgent review
5. considers the recommendations of the Data Monitoring Committee
6. in the light of 2, 3, 4 & 5 reviews and takes responsibility for any scientific decisions about the trial design, safety concerns etc
7. advises funders and sponsors on publicity and the presentation of all aspects of the trial
8. makes recommendations to the Programme Management Board on any necessary changes to trial sites
9. included in its membership are two Community Representatives who have particular responsibility for reviewing and advising on further development of information/materials to be disseminated to participants and to civil society during the trial.

Current Membership of the TSC

TSC Chair: Anna Glasier

Independent Members: Mike Chirenje Anne Johnson Alwyn Mwinga

Community Members: Christopher Smagaliso Ntshele Angelina Wapakabulo

MDP Investigators: Janet Darbyshire Heiner Grosskurth Richard Hayes Jonathan Weber