To assess medicines for safety and efficacy that clinical trials need to be representative factors like biological sex and ethnicity. Too often, there is an underrepresentation of one key group or another in clinical trial subject populations. This leads to erroneous data where a societal group differs in presentation, clinical manifestations, and outcomes in comparison to others.
Despite a U.S. congressional ruling that was signed into law by President Biden earlier this year, requiring drug and device sponsors to submit diversity action plans with clinical trial data, conducting diverse clinical trials remains a significant challenge. This is according to a new report issued from the health data experts at H1.
Using H1’s clinical trial data platform, Trial Landscape, experts have analysed data on nearly 13,000 clinical trials from 11.2 million breast cancer claims alongside the 2020 census data. The findings reveal a disconnect between actual patient populations and trial locations when it comes to breast cancer.
H1’s data assessment demonstrates how most breast cancer clinical trials are not accessible to or inclusive of the diverse patient populations actually diagnosed with the disease. This will have consequences for trial outcomes.
The U.S. Food and Drug Administration (FDA) advises medical product sponsors to develop
Race and Ethnicity Diversity Plans and to seek diversity beyond just race and ethnicity by including other underrepresented populations, including those defined by their socioeconomic status, age, disability, and gender identity. This has been supported by some pharmaceutical manufacturers, but not all.
For example, in the area of Grand Rapids, Michigan, census data shows a significant number of Black patients with breast cancer but a low number of hospital admissions, suggesting patients may seek treatment elsewhere.
It also shows that clinical trials are not being conducted at sites in close proximity to these patients, suggesting that trial data is not inclusive of real-world patient populations.
One reason for such errors is an overreliance upon census data. U.S. Census Bureau data do not necessarily reflect the proportion of the population by ethnicity that may be impacted by a specific disease. For instance, a recent GSK study found that in four disease areas (asthma, COPD, HIV, and influenza) census data differed from the epidemiological data.
H1’s CEO Ariel Katz has reflected on the changes needed to make clinical trials more accessible and diverse.
In a statement provided to Digital Journal, Katz observes: “As an industry, we all agree that inclusivity and proper representation in clinical trials are not optional. Our report highlights the distance between intentions and change. Companies have to go beyond surface-level demographic data to understand impacted patient populations and the hurdles they face in participating in trials.”
