STREAM Clinical Trial
The Union, Vital Strategies, and key global partners including the Medical Research Council Clinical Trials Unit at University College London, Institute of Tropical Medicine, Antwerp and Liverpool School of Tropical Medicine, are working with TREAT TB partners at sites throughout Asia, Africa, and Eastern Europe to implement the STREAM trial. To successfully carry out the trial, a diverse team, including scientists, physicians, nurses, microbiologists, laboratory technicians, statisticians, data managers, finance and operations experts, trial coordinators, community engagement experts, and dedicated support staff, such as drivers, hospital attendants and many others, must work together seamlessly.
STREAM Stage 2 requires 12 trial drug formulations to be available at the sites to implement the trial. Therefore, each STREAM trial site has at least one dedicated pharmacist and one pharmacy technician to manage the supply chain of trial drugs and ensure that each patient receives MDR-TB treatment daily. The trial drugs are sourced from the manufacturers, sent to the trial pharmacist at each site, repackaged into daily packs, and dispensed to the patients enrolled in the trial. Click here for more details.
Each STREAM site needs an experienced trial coordinator, or site manager, to coordinate all operational aspects of the trial. STREAM trial coordinators typically work directly with the site’s principal investigator(s) and ensure that all members of their site’s research team implement the trial ethically, in accordance with the STREAM protocol and all other rules and regulations. They help ensure that materials and supplies for the trial are purchased and available during the trial. They also maintain all trial documents for their site and act as a critical communications link between STREAM sites, the trial Sponsor, and donors. Click here for more details.
Finance & Operations
Finance and operations experts play a fundamental role in establishing the initial agreements among STREAM partners required to initiate the trial, and are crucial to the ongoing implementation of the trial. The finance and operations team typically includes a finance/operations expert, as well as a grants or contracts manager. The team works to prepare contracts and budgets for the site and, once the trial is up and running at the site, helps to ensure that necessary infrastructure and supplies are procured, monitors expenditures for the trial to ensure they are in line with the budget, prepares reports on trial implementation for review and approval by donors, and oversees compliance with USAID and other regulations. Click here for more details.
Other Support Staff
It would be impossible to implement the trial without the support of a wide range of other support staff, including drivers, cleaners, hospital attendants, and many others. These dedicated team members make sure that people and supplies are transported where needed, that facilities are kept clean to maintain the health and safety of patients and staff, and that the full range of patients’ needs are addressed while receiving care at STREAM sites. Click here for more details.