The Food and Drug Administration (FDA) is working to increase the participation of people in racial, ethnic and other minority groups in the clinical trials that test new medical products.
Why is this important?
Ensuring meaningful representation of minorities in clinical trials for regulated medical products is fundamental to FDA’s regulatory mission and public health, says Jonca Bull, M.D., director of the agency’s Office of Minority Health (OMH). Racial and ethnic minorities include African American, American Indian, Alaska Native, Asian American, Hispanic American, Native Hawaiian and Pacific Islander communities.
OMH project manager Christine Merenda, M.P.H., R.N. explains that clinical trials are the proving ground for new drugs, vaccines and devices. They provide the data that will determine whether FDA approves a manufacturer’s application for marketing approval.
“Potential racial, ethnic and other differences in response to drugs are important to FDA’s efforts to help ensure that the safety and effectiveness of drugs are studied in all people who will use the products once they are approved,” she says.
Considering Genetic Differences
Bull explains that there are biological differences in how people process drugs. For example, variations in genetic coding can make a cancer treatment more toxic in one ethnic group than it would be in another. These variations can make also make drugs like antidepressants and blood pressure medications less effective in one group than another.
Getting more data on these differences is essential for FDA to truly know that a medical product will truly work and be safe for all patients, Bull says.
Members of minority groups may be more vulnerable to certain diseases. “We know, for example, that African Americans and Hispanics have higher rates of diabetes, HIV/AIDS, obesity and cardiovascular disease,” says Bull.
Read more about clinical trials and people of color at BlackHealthMatters.Com.
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