With few Hispanics in clinical trials, FDA seeks help from doctors
Education plan hopes to increase participation rate
Two decades ago, Luis Antonio Cabrera received devastating news: He likely had only three months to live.
The Puerto Rican truck driver, then 50, had attributed his growing leg pain to spending so many hours on the road. The real culprit was a malignant tumor in his left kidney that was pressing on nerves from his lower spine.
His initial treatment involved removing the organ, a complex surgery that, by itself, proved insufficient, as the cancerous cells had already spread to his lungs. Therefore, his primary care physician in Puerto Rico contacted doctors at the National Institutes of Health, in Bethesda, Md., and managed to enroll Cabrera in a medical study to test an innovative therapy: transplanting blood stem cells to destroy the cancer cells.
Today, at 70, Cabrera, a father of five and grandparent who moved to West Virginia with his wife to be closer to NIH, feels strong and healthy. “I come to do tests every six months. I’m like a patient at-large,” he said.
However, Cabrera is one of a relatively small number of Hispanics who participate in clinical trials. “Only less than 8 percent of enrollees are Hispanic, even though Hispanics comprise 17 percent of the population,” said Dr. Eliseo Perez-Stable, director of NIH’s National Institute on Minority Health and Health Disparities.
That means not only do Hispanics have less access to experimental cuttingedge treatments but researchers have less data on how a drug works in that population. Studies have shown that different ethnic groups might respond differently to treatments. The lack of patients from minority groups is an endemic problem in clinical trials; minorities typically are represented at a very low rate.
“Studies should represent the demographics of the country,” said Dr. Jonca Bull, an assistant commissioner on minority health at the Food and Drug Administration. “We need to close that gap so we can better understand how a particular drug or therapy works in different communities.”
There are many reasons why Latinos do not enroll in these studies, PerezStable said: lack of information, disparities in access to health care and not being fluent in English are among main factors. Dr. Otis Brawley, chief medical officer with the American Cancer Society, said Latino families are open to participating in clinical trials, especially to help treat a sick son or daughter, but they need advice from a doctor to navigate the process.
Federal officials aim to augment these numbers. In March, the FDA launched a campaign to educate Hispanics about medical studies. “Primary care physicians have to be the champions. In addition, the community health centers can help, because they are places of care that people trust,” said Bull.
As of July 5, there were 94,545 ongoing clinical trials in the United States, according to the NIH’s official website, clinicaltrials. gov. As in Cabrera’s case, the primary physician usually helps a patient find a medical study, although the advent of the internet in recent decades has meant a growing number of patients discover trials themselves online. To participate, the person must meet the researchers’ criteria for eligibility: age, gender or condition. Often, the center conducting the study covers related costs of drugs, treatments and tests.
These days, “Hispanics receive less quality medical care, so it’s important for them to be more involved in clinical trials,” said Brawley, noting that enrolling in a clinical trial gives patients access to a high-quality physician they might not otherwise see.