| Austin American-Statesman
Black and Latino patients have far less access to potentially life-saving experimental drugs than white Americans. As the Biden administration and research industry address the COVID-19 pandemic and plan for the next one, they must make health equity a priority in our nation’s drug development process.
Communities of color are profoundly underrepresented across medical research. A study in JAMA Oncology looked at the racial composition of participants in 230 cancer drug trials between 2008 and 2018, and out of a total of more than 112,000 people, Latinos made up just 6 percent of participants, and Blacks just 3 percent.
Similar disparities exist with regard to other diseases that disproportionately impact people of color, including Alzheimer’s, the third-leading cause of death for older Latino Americans and fourth-leading for older Black Americans.
These groups make up less than 20 percent of all clinical trial participants in federally funded Alzheimer’s research. Yet Blacks are two times more likely and Latinos one and half times more likely to develop Alzheimer’s than White Americans.
This access gap undercuts the credibility of the research community and harms public health.
The ability to develop effective medicines that work for all is essential to building a healthier America and eliminating health disparities. FDA data suggests that one in five drug approvals noted differences in the drug’s response across racial and ethnic groups, sometimes prompting population-specific prescribing recommendations.
Clinical trials are also how patients get early access to treatments that are experimental, but potentially life-saving. People of color are too often left out of these opportunities, shortchanging them when they are disproportionately affected by diseases such as COVID-19 and Alzheimer’s.
Now is the time to chart a different path forward.
On his first day in office, President Biden signed an executive order that vows to “assess whether underserved communities and their members face systemic barriers in accessing benefits and opportunities.” This assessment must include a careful review of the policies and practices by the National Institutes of Health and its funded researchers that have led to the exclusion of millions from life-saving research.
Meanwhile, in the private sector, the biopharmaceutical industry issued principles on clinical trial diversity in late 2020 to “better serve historically underserved communities.” The roadmap sets goals to improve access to clinical trials among communities of color, monitor how treatments work in diverse populations once approved, and be transparent about efforts aimed at inclusion.
Industry and government must build on this momentum by turning commitments into tangible action. There are two steps the health care sector can take to advance this.
First, companies and their regulators must broaden the criteria for research eligibility — and create more flexibility in research protocols — to address barriers that often stand in the way of Latino and Black participation. Strict eligibility criteria, such as the exclusion of individuals living with diabetes, for Alzheimer’s and other trials can lead to limited representation of minorities in clinical research, especially given the multiple chronic conditions that Black Americans and Latinos often face.
Second, government and industry stakeholders must collect and report comprehensive data on the race, ethnicity and language of patients enrolled in clinical research on a regular and timely basis. Comprehensive data enables the field to tailor solutions and hold actors accountable for reducing disparities among people of color.
Without representative medical research, industry and government will continue to deliver innovations that work better for some groups than for others, and lines will continue to be drawn by race and income instead of need and equity. All of us must do better.
Resendez is head of the LatinosAgainstAlzheimer’s Coalition and a member of the Health Equity Collaborative.
