Genentech is dedicated to inclusive research to advance science and improve health outcomes for all patients.
Putting patients first is what we do at Genentech. We firmly believe that including underrepresented, underserved and diverse patients in clinical research can help advance science and improve health outcomes for all patients. We're working to build trust in communities, give hope and support to patients on their healthcare journey.
We've made progress in achieving diverse enrollment in clinical studies by focusing on diseases that disproportionately impact underrepresented populations.
Building on practices developed from the Evaluating Minority Patients with Actemra (EMPACTA) and Characterization of Ocrelizumab in Minorities With Multiple Sclerosis (CHIMES) studies, US Medical Affairs is leading efforts to advance inclusive research by enrolling patients from Indigenous populations in studies - including CATORI, a non-interventional clinical study to determine the unique barriers that Indigenous communities face when trying to access specialty care. CATORI is a groundbreaking study solely dedicated to this patient population, with the first patient enrolled in Q4 2022. Additionally, our ELEVATUM study is the first retinal clinical study of its kind to research diabetic macular edema in Black/African American, Hispanic/Latinx and Indigenous populations.
Product Development (PD) is embracing inclusive action plans at the program level. Our late-stage lupus nephritis program targets people disproportionately affected by the disease - women, Black/African Americans, Hispanics/Latinx, Native Americans and Asian Americans. "Through targeted action plans, we doubled the percentage of enrolled Patients of Color in our pivotal Phase III studies compared to our Phase II studies," says Jodi Bridge, Senior Clinical Operations Leader, Roche.
Late Stage Development attributes success like this to taking time to better understand the barriers that under represented patients face. "When teams seek to listen and learn from patients directly, they can identify actions that will have meaningful impact, such as creating culturally sensitive materials, engaging community-based sites and having focused inclusive research discussions with study staff," says Gerren Wilson, Pharm.D., Lifecycle Leader and Franchise Lead, Respiratory.
In Genentech Research and Early Development (gRED), Mark McCarthy, M.D., Principal Fellow and Executive Director, Department of Human Genetics, is exploring the interplay between genetics, research and health equity - and the potential for more diverse genetic data to create a more equitable health landscape. He shared his work in It's Personal: Inclusive Research and Precision Medicine, a two-part podcast series dedicated to inclusivity and diversity in research.
Seppi Lin, M.D., Vice President and Head of OMNI Early Clinical Development says, "From bench to bedside, we remain committed to pushing boundaries to increase representation in our clinical studies and realize the next era of transformational medical advances for the benefit of all patients worldwide."
"Excluding participants with other health conditions, which can be more severe in Black/African American populations, would have been a disservice to our patients and our study."
Juan Acosta, M.D. Senior Medical Director, U.S. Medical Affairs Neuroimmunology and part of the CHIMES team, Genentech
