By Quita Highsmith, MBA, Chief Diversity Officer, Genentech
Jamie Freedman, M.D., Ph.D., Head of U.S. Medical Affairs, Genentech
Earlier in the coronavirus outbreak, U.S. health authorities reported that African Americans, Hispanics, and other underrepresented groups faced greater risk of Covid-19 infection and were experiencing significantly higher hospitalization and mortality rates.1 Mounting evidence in New York City showed the virus was killing African Americans and Hispanics at twice the rate of Caucasians.2 The statistics were disturbing, but the phenomenon was unfortunately not a surprise.
The disparities are due, in part, to underlying health and economic challenges faced by people in severely affected communities.3 However, the Covid-19 crisis also casts a spotlight on a broader, glaring inequity. Despite more than 30 years of public and private initiatives, racial and ethnic minorities still have fewer opportunities to participate in clinical research.4
Why does this matter in a pandemic? Because by participating in clinical trials, individuals in these groups can gain access to investigational therapies to treat Covid-19. What’s more, boosting research diversity can help investigators understand whether investigational therapies are safe and effective for a broader set of patients — or whether differences in race, gender, and ethnicity might impact a drug’s safety and effectiveness.
“The Covid-19 public health crisis is amplifying health disparities that have negatively impacted communities of color for decades. It’s difficult to find people of diverse backgrounds who have experience participating in clinical trials. This gap extends beyond diversity in patient selection into almost every aspect of clinical research — including the diseases organizations choose to study, where they locate the sites, and which investigators they enlist. We aim to design programs that address these types of deficits.” – Quita Highsmith
URGENCY & EQUITY
When news of Covid-19 health disparities hit in 2020, Genentech’s Medical Affairs team sprang into action, knowing the clock to study treatments in a pandemic was urgently ticking. They met with physicians in hospitals that treat a high proportion of underserved and minority patients and quickly developed a randomized, placebo-controlled study called EMPACTA. The study enrolled patients in the spring of 2021 with Covid-19 pneumonia at hospitals across the United States that reached underserved communities, including several public hospitals in New York City, where we first reached out.
The trial came together in only two weeks — something that would normally take months and months of work.
|“Going forward, our experience with Covid-19 may very well reset the benchmark for everything we do in clinical research. We have broken barriers we never knew existed, and this will lead to accelerated timelines and efficiencies for inclusive research all across our treatment portfolios.” – Jamie Freedman|
While speed was a priority, it was important to not lose sight of creating this study with equity in mind. The Medical Affairs team chose eligibility criteria that take into account variation among racial and ethnic groups. Otherwise, there’s a risk of excluding patients based on population-wide variances in criteria related to type 2 diabetes or kidney function. Such differences may be an unreliable signal that a health condition renders the patient ineligible for the study.5
|“To create more inclusive clinical trials, we must start with the fundamentals. It begins with asking site investigators to be more intentional about recruiting diverse patients. We also must expand site networks to include potentially smaller, newer sites with more diverse catchment areas.” – Quita Highsmith|
Due to Genentech’s strong foundation in diversity and inclusion, we were able to launch into action quickly. Years before the current pandemic, Genentech identified research disparities and lack of diversity as a hurdle in drug development. Through our company-wide initiative called Advancing Inclusive Research™, we began to address the lack of racial and ethnic representation in clinical programs. Given this focus, diversity was top of mind last spring when we began exploring potential clinical trials in Covid-19.
A CALL TO OUR INDUSTRY
As we double-down on our efforts to address health disparities in clinical research, we recognize that to effect real change requires deliberate, bold investments. Not just by one company or hospital, but by groups of stakeholders banded together. In the face of this devastating pandemic, there arguably have never been greater stakes.
We call on all those working in biopharma to join us in developing and studying treatments that can benefit all patients. We owe it to the world. One of the most critical learnings from the past two years is that we must place diversity and inclusion at the forefront of our fight against Covid-19, if we ever want to truly conquer this disease.
For more information, visit gene.com/patients/advancing-inclusive-research.
1 Centers for Disease Control & Prevention. COVID-19 in Racial and Ethnic Minority Groups. Risk of Severe Illness or Death From COVID-19: Racial and Ethnic Health Disparities. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-illness.html. Accessed January 21, 2022.
2 NYC Health. Age-adjusted rates of lab confirmed COVID-19 nonhospitalized cases, estimated non-fatal hospitalized cases, and patients known to have died by race/ethnicity group as of April 16, 2020. https://www1.nyc.gov/assets/doh/downloads/pdf/imm/covid-19-deaths-race-ethnicity-04162020-1.pdf. Accessed January 21, 2022.
3 Kaiser Family Foundation. Low-Income and Communities of Color at Higher Risk of Serious Illness if Infected with Coronavirus. https://www.kff.org/disparities-policy/issue-brief/low-income-and-communities-of-color-at-higher-risk-of-serious-illness-if-infected-with-coronavirus/. Accessed January 21, 2022.
4 National Institutes of Health. NIH Inclusion Data by Research and Disease Category. https://nexus.od.nih.gov/all/2019/05/06/nih-inclusion-data-by-research-and-disease-category-now-available/. Accessed January 21, 2022.
5 National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases. Sickle Cell Trait & Other Hemoglobinopathies & Diabetes. https://www.niddk.nih.gov/health-information/professionals/clinical-tools-patient-management/diabetes/sickle-cell-trait-hemoglobinopathies-diabetes?dkrd=/health-information/diagnostic-tests/sickle-cell-trait-hemoglobinopathies-diabetes. Accessed January 21, 2022.