The impact of the COVID-19 pandemic on tuberculosis (TB) programs is expected to be profound. Recent models predict over 126,000 excess TB deaths globally over the next five years for every one month of COVID-19-related lockdown. In this environment, implementation of TB clinical trials is especially challenging, given their complex regulatory and operational requirements.
The STREAM clinical trial is the largest MDR-TB trial ever conducted. When the pandemic began, a significant number of STREAM participants were still on treatment and most were still in follow up. Recently, the Tropical Medicine and Infectious Disease journal published a commentary by Dr. I.D. Rusen, Senior Vice President of Vital Strategies’ Research Division, detailing how the COVID-19 pandemic is impacting implementation of STREAM and other TB clinical trials. The commentary also highlights how the trial’s timely and effective response ensured: no trial participant has experienced a treatment interruption arising from the pandemic, despite significant supply chain disruptions; rapid implementation of a risk-based system of clinical monitoring that accounts for the added risk of exposure to COVID-19 in connection with in-person clinic visits; and minimal loss of key trial data arising from missed visits/samples.
The experience of the STREAM trial against the backdrop of the pandemic highlights the importance of contingency planning and risk mitigation both before and during unanticipated crises.
To read Dr. Rusen’s full commentary in the Tropical Medicine and Infectious Disease, please click here.