Several recent Genentech studies offer prime examples of the steps researchers can take to expand access to clinical studies for underrepresented patient groups efficiently and, most importantly, effectively.
EMPACTA. Black/African American and Hispanic/Latinx* patients have been disproportionately impacted by COVID-19. Genentech's Evaluating Minority Patients with Actemra (EMPACTA) study, a Phase III study for patients hospitalized with COVID-19 pneumonia, was designed in collaboration with physicians at hospitals with diverse patient populations, creating a streamlined outreach process. EMPACTA enrolled 389 participants in less than one month — 84% from underrepresented groups.
CHIMES. The Phase IV characterization of ocrelizumab in minorities with multiple sclerosis (CHIMES) study, which focuses on Black/African American and Hispanic/Latinx patients with relapsing-remitting multiple sclerosis, drew on learnings from EMPACTA to make participation as convenient as possible. The team incorporated services to remove participation barriers, including on-demand transportation, a patient stipend and culturally competent education materials. CHIMES exceeded its target, enrolling 182 Black/African American or Hispanic/Latinx patients ahead of schedule.
ELEVATUM. ELEVATUM is a post-approval study to expand our understanding of Vabysmo in Black/African American, Hispanic/Latinx, Native American and Pacific Islander patients with diabetic macular edema. Set to start enrolling in 2022, the ELEVATUM team used best practices from both CHIMES and EMPACTA to focus on design and operational elements that will remove barriers to participation among historically underrepresented patients. ELEVATUM will offer free, door-to-door transportation and patient stipends.
A common belief is that inclusive research practices can slow recruitment and generate poor quality data. However, we hypothesized, then proved, that simplified study design for patients at community sites can answer the most fundamental questions for how all patients can benefit from new medicines.
- Jamie Freedman, M.D., Ph.D., Senior Vice President, Head of U.S. Medical Affairs, U.S. Commercial, Medical & Government Affairs
We believe these studies help change the narrative that building more inclusive studies requires budgeting more time for recruitment. Perhaps more importantly, these efforts show that there’s no good reason for researchers to avoid prioritizing inclusive research in clinical studies. “Continually having inclusive research studies is important, and learning from them is important,” says Jenny Chang, senior clinical study lead. “But the main goal is to ensure that every study has these components built into their design, and where every study is inherently inclusive.”