Latinos and others need to be better represented in clinical trials
Demographic Diversity
Because clinical trials are the foundation of new drug approvals, they must accurately reflect the makeup of the patients who ultimately receive the drugs. Age, sex, health parameters and race/ethnicity can play a role in how an individual responds to a given drug.
However, researchers acknowledge that demographic diversity in clinical trials remains a problem. In many clinical trials, race is not even mentioned. In others, Latino and Black populations are underrepresented.
According to a 2019 article in Current Problems in Cardiology, “Lack of diversity in clinical trials is a moral, scientific, and medical issue. When trial participants are homogenous (e.g., primarily one gender, race/ethnicity, or age group), findings may be skewed and result in a body of clinical knowledge that is not generalizable. Cardiovascular health and outcomes vary among racial and ethnic groups.”
In an article in Medical News Today (https://www.medicalnewstoday.com/articles/increasing-diversity-in-clinical-trials-what-can-doctors-regulators-and-patients-do), Richardae Araojo, FDA Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE), said, “It is important for clinical trial participants to reflect the diversity of the population that is going to use the product so that sub-population data can be appropriately analyzed, and more meaningful clinical data can be communicated to the public. There are many benefits to diverse participation for researchers that extend, in a larger sense, to society. Racial and ethnic minority participation helps researchers find better treatments and better ways to fight diseases like cancer, diabetes, and heart disease, among other conditions that disproportionately impact diverse communities. In addition, it uncovers differences by race and ethnicity that may be important for the safe and effective use of therapies.”
Why do many clinical trials lack diversity of participants? There may be language barriers, cultural differences, health literacy, lack of awareness about clinical trials, lack of recruitment and retention, accessibility, frequency of study visits, transportation, and conflicts with work or family obligations. asked.”
How can diversity in clinical trials be addressed? Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to investigate how well demographic subgroups (sex, age, race, and ethnicity) in applications for medical products – drugs, biologics and devices, submitted to the agency for marketing approval -- are included in clinical trials; and if subgroup-specific safety and effectiveness data are available.
As explained on the FDA website (https://www.fda.gov/patients/clinical-trials-what-patients-need-know/diversity-clinical-trial-participation,” “It is important to test drugs and medical products in the people they are meant to help. FDA works to make sure that people of different ages, races, ethnic groups, and genders are included in clinical trials. The Office of Minority Health is leading groups made up of many FDA centers to develop actions that will reduce health disparities.”
While some strides have been made to correct the disparities, the issues still exist. FDA’s Office of Minority Health and Health Equity (OMHHE) is using culturally and linguistically effective strategies and resources, including an awareness campaign, educational material, public service announcements, and social media programs in English and Spanish. OMHHE also provides outreach to diverse communities and healthcare professionals and collaborations across industry, academia, and the government to raise awareness about the need for more diversity in clinical trials.