Clinical Drug Trials Aren’t Representative of America; This Group Wants to Change That

Consider these numbers: According to Census data, Hispanics make up 16 percent of the entire population of the United States. In clinical trials, however, the Food and Drug Administration says they represent a mere 1 percent.

Now, zoom into Texas, where 38 percent of residents are Hispanic. Look even closer at Hidalgo County, which includes McAllen, and see that percentage balloon to 90.9. Dr. Carlos Cardenas, the chairman of the board of Doctors Hospital in McAllen, let out a small-but-audible sigh while discussing the disparity in the minority population at large compared to its makeup in clinical trials of drugs angling for approval by the FDA.

“I think if the gap doesn’t close, we’ll continue to see issues with medications,” he says. “If the population studied isn’t a reflection of the population being treated, we may end up with complications.”

Cardenas is part of a national effort to make clinical trials resemble America’s racial makeup. Hispanics, blacks, and Asian Americans are significantly underrepresented in this research, advocates say, which has broad implications for those demographics. Different races are more susceptible to different conditions and have varying reactions to certain medications, the FDA says.

“In the African-American community, we know there are hypertension treatments that don’t work well,” Cardenas says. “Had research not been done in those populations, I don’t know that we would’ve learned that as quickly as we have. I really don’t think we want to see history repeat itself.”

This week, the Pharmaceutical Research and Manufacturers of America (PhRMA) teamed with the National Minority Quality Forum to launch the so-called I’m In campaign, which advocates for greater diversity in clinical trials.

The movement sprung from the findings of a 2013 FDA report on this very subject, which plainly states, “Whites represented a high percentage of trial participants. In many cases, other racial subgroups were underrepresented.”

In some trials, Latinos made up as little as .03 percent, as was the case for a clinical trial studying melanoma, or as much as 35 percent, such as one for treatment of hepatitis B. Of the 23 trials studied by the FDA that included race as an identifier, 16 featured 10 percent or fewer Hispanic volunteers. Of those, 12 were conducted with fewer than 5 percent Latinos.

This is especially alarming for states such as Texas, where Hispanics are expected to be the most populous race in less than a decade. Part of this is blamed on racial concentration: These trials are typically conducted in urban centers that sport a healthy medical industry, Cardenas said.

Pharmaceutical companies aren’t as likely to travel to regions like the Rio Grande Valley, where the racial makeup is drastically different and the resources aren’t as plentiful. This, says John Castellani, president and CEO of PhRMA, is why it’s such a big deal that I’m In features the representatives that it does.

“Through this collaboration of healthcare leaders, we are taking a major step forward to help reduce health disparities through greater inclusiveness in clinical research,” he says.

Medical companies conducting the trials can now analyze computer databases and target specific communities based on demographics, Cardenas says. The push will also aim to spread health literacy and quash the stigma that some feel about medical research, he added. But the doctor is hopeful.

“We’re better equipped today than we have been in the past,” he says. “We’re going to have the opportunity to bring trials to  areas of the state that haven’t had them before, at least not easy access.”