Advances in medical research provide a better understanding of the many factors that cause lupus. Doctors can diagnose lupus earlier in the disease process, and scientists are developing more targeted and less toxic lupus therapies thanks to what they’ve learned from clinical trials.
But researchers and investigators for lupus clinical trials say they sometimes have a hard time finding volunteer participants among certain racial, ethnic, and cultural groups. Some of the reasons have to do with minorities’ bleak past experiences in clinical trials, but more may be linked directly to access issues and lack of information, says Ken Getz, chairman and founder of the Center for Information and Study on Clinical Research Participation.
“The legacy of tragic research studies is less of an influence today than it was in the past,” Getz says. “It’s still there, but a lot of studies document really high levels of interest in clinical research among some subsets of the population, especially if they knew more about the studies and how to assess their personal benefits and risks.”
Confronting a legacy
In 1994, Benjamin Pruitt, an African American who was a professional musician at the time, had recently moved to Washington, DC. He didn’t have a regular physician and he didn’t have major medical insurance, but he was experiencing a serious flare of the systemic lupus that had been diagnosed 10 years earlier.
Pruitt joined a lupus research trial at the National Institutes of Health at the suggestion of a friend. He explains that the trial was testing a low-dose chemotherapy treatment.
“It was an option for me to receive the necessary medical treatment and attention that my disease needed at the time,” says Pruitt, 47, who is now dean of students at a public charter school. “What helped me in my decision [to participate in the trial] was becoming as educated as I could.”
When asked if he would do it again, however, Pruitt says it would depend on what the study was and what the benefits would be. He speaks with some skepticism about researchers’ agendas. He also reflects on some of the tense history between African Americans and government and medical professionals, referring to the Tuskegee syphilis study. That study was a government-sponsored experiment conducted for 40 years before being shut down in 1972. Researchers observed the effects of syphilis on mostly poor and uneducated black men who were not told about or treated for the disease, even when simple lifesaving treatment was available.
But learning about, accessing, and participating in clinical trials for lupus can be empowering steps for lupus patients today, says Edie Aultmon, 47, an African American woman diagnosed with lupus in 1984. Aultmon received treatment in 2000 as part of a clinical trial for medication to treat lupus-related fibromyalgia at Georgetown University in Washington, DC. She has since become a volunteer for the Lupus Foundation of America’s Greater Washington Chapter, attending local health fairs where she distributes information about the disease and ongoing opportunities for clinical trial participation.
“I know several people with lupus who are pleased with being in a trial because it gives them a way to access medicine and care for their illness that they otherwise can’t afford,” Aultmon says. “But I don’t think a lot of African Americans with lupus are aware of the many trials taking place.
“I never had access to a trial until I had a doctor who had access to one,” she continues. “How to get people to do it is to tell them. They won’t know if nobody tells them.”
Involving at-risk populations
With a disease like lupus that disproportionately affects African Americans, Hispanics/Latinos, Asians, Pacific Islanders, and Native Americans, it is especially important to include these ethnicities in lupus studies, says rheumatologist and lupus researcher Graciela Alarcón, M.D., M.P.H., of the University of Alabama in Birmingham. Ninety percent of those diagnosed with lupus are women, and the disease is two to three times more common among these groups. The severity of lupus also tends to be higher among these populations than among Caucasians.
With the heavy toll lupus takes on these populations, one might presume that many of those affected would jump at the chance to help further research in the battle against it. However, this is not the case, as individuals in these groups generally are underrepresented in clinical trials.
A Johns Hopkins University study released in January 2008 reported that African American participants in a mock cardiovascular drug trial in Maryland were 200 percent more likely than Caucasian participants to perceive experiencing harm as a result of their participation and to distrust medical researchers.
The researchers add that without the participation in clinical trials of members of at-risk populations, scientists cannot test the therapies needed to treat the diseases that affect these underrepresented groups.
Making information—and trials themselves—more accessible
Another study on the willingness of these at-risk populations to get involved in clinical research, published in 2005, found that several factors other than mistrust contribute to an individual’s decision to enroll in a trial. These include whether they are informed about research opportunities, whether they are medically eligible to participate, and whether personal circumstances—such as child care demands, job flexibility, and how close they are to research sites—make it possible for them to participate.
Indeed, this study concluded that racial and ethnic groups in the United States are just as willing as Caucasians to participate in health research.
The locations and design of the trials both create large barriers to participation, Getz says.
“Typically studies are conducted among white physicians, with a much smaller proportion based in inner-city and urban areas, so there is even a geographical bias here,” he says. “When a pharmaceutical company places a study site in the New York metropolitan area with white physicians, there is a good chance it will not be in some of the highest minority population areas.”
Community and local health professionals need to receive ongoing training in the protection of study participants. Doctors and researchers also need to effectively communicate these safeguards to participants to build trust and overcome perceptions of mistrust.
A diverse research staff can help lead to a diverse panel of study subjects. For studies with a large contingent of non-native English speakers, someone who speaks the same language as the potential participants is critical for explaining a study properly and answering questions to gain consent, Alarcón says. And to gain the trust of people with a disease like lupus that affects minorities, a study assistant or coordinator who is of the same race or ethnicity as the participants can be invaluable.
“With a good team, you improve the probability that you will be able to attract minority participants,” Alarcón says. “You need to make sure they understand that you are looking out for each person’s well-being and that the participant is not just another number in your protocol.”
Liezl de la Cruz-Tracy, a certified clinical research coordinator in the lupus program at the Medical University of South Carolina in Charleston, says her team sends study investigators out to health fairs and churches among the large African Methodist Episcopalian community of the region to share information about lupus. This initial contact is generally separate from trial recruitment, focusing more on health education. But this sort of outreach does sow the seeds of trust so people feel free to come in and discuss potential trial participation with the trial coordinators, de la Cruz-Tracy says.
“It helps to have coordinators of the same background, but really it’s about whether [the people in the community] are comfortable with coordinators or not,” she says. “It’s up to us to take people’s cues and to generate or establish trust with potential participants.”
Participants need to be able to express their concerns, Alarcón says, and she encourages them to bring those concerns to the table rather than to just say “no” from the outset.
“Without clinical trials, no matter how much we advance in the laboratory, there is no way to advance in the treatment,” she explains. “You can’t go from experimental animal studies directly to the public [using of the drug product]. You need the clinical research layers. People need to understand that without these clinical trials in people, there would be no drug development progress.”
Speaking the whole truth
The heart of the issue comes down to cultural sensitivity on the part of the researcher, says Robin L. Brey, M.D., a professor of neurology, associate dean for research, and deputy director of the Institute for Integration of Medicine and Science at the University of Texas Health Science Center at San Antonio.
“Researchers have to do their homework in terms of understanding the needs of a study participant and understanding that these needs have to be met by being involved in the study,” Brey says. “I see clinical research as a partnership between the researcher and the participant, not a one-way street of the participant giving without getting something back.”
Often basic things, like the words used when talking to people about a study, are important, she continues. Does the researcher make it clear that the participant will be a “partner” in the study process? Is the study explained in a way that is respectful and understandable? Are the person’s questions answered appropriately? Do they have enough information to decide that participating in clinical research is going to be beneficial?
Clinical research is an important part of understanding the lupus treatments on the market and on the horizon and there is a lot of opportunity today to become more educated about it.
“That’s the good news,” Getz says. “People can be much more sophisticated decision-makers today about whether to find and join clinical trials.