Diversity in Veklury® Clinical Trials
Inclusion is one of Gilead’s core values and encouraging diversity in our research programs helps us understand how our treatments affect all the populations we serve. That approach is especially important now since the burden of the COVID-19 pandemic is falling disproportionately on people from minority and underserved communities. We are actively working to include a diverse group of participants, including marginalized and underrepresented communities, across all of our clinical trials evaluating Veklury® (remdesivir).
When designing our SIMPLE clinical trials of Veklury in COVID-19, we ensured that clinical trial enrollment was offered at sites across a broad U.S. geographic area, including many urban centers with a significant burden of COVID-19 cases including New York, New Jersey, Michigan, New Orleans and Chicago. By focusing on major metropolitan areas and working with clinical trial sites with broad patient coverage, we enrolled more Black, Hispanic and Asian patients.
An evaluation of Veklury’s safety and efficacy across different racial and ethnic subgroups treated in our SIMPLE-Severe trial demonstrated that traditionally marginalized racial/ethnic groups did not have worse clinical outcomes than other groups. This analysis was presented at the 23rd International AIDS Conference in July 2020, and we continue to explore how to ensure data from these relevant populations are reflected in our clinical trial designs.
In addition to designing trials to ensure adequate representation, we are partnering with the Satcher Health Leadership Institute at Morehouse School of Medicine to study racial health inequities associated with COVID-19. We are supporting the creation of a data map in order to improve care in underserved communities.
The tool will provide the ability to collect and study the demographic disparities associated with COVID-19, with the goal of using the data to help create actionable, evidence-based policy changes to attain health equity and ensure that disproportionately impacted communities receive resources and support.