Minority patients ignored in HIV drug trials
Both doctors and patients might be at fault
Using a snapshot representing all HIV patients in the United States, researchers found that African-Americans and Latinos had substantially less access to clinical trials than whites. "This was true even when they had comparable health insurance, socioeconomic status, and education to whites," says Allen L. Gifford, MD, assistant professor of medicine at the Center for Research on Patient-Oriented Care, the VA San Diego Healthcare System and the University of California - San Diego Department of Medicine in San Diego.
The analysis was conducted as part of the RAND-led HIV Cost and Services Utilization Study Consortium, which is sponsored by the Agency for Healthcare Research and Quality in Rockville, MD. Its chief findings were that race or ethnic group and type of health insurance influence HIV patients’ participation in research trials and access to experimental treatment.1 "We were specifically interested in the issue of experimental trials and medication," Gifford says. "This is a piece of an overarching and emerging area of research that describes different ways in which people from minority groups often tend to be underserved with access to treatment, particularly with diseases such as HIV where treatments develop very rapidly."
With HIV disease, those patients who are not receiving the latest medications, as might be offered in clinical trials, are put at a disadvantage clinically because conventional treatment offers limited options, particularly as their drug regimens begin to fail. "So I think it’s a significant issue that people have as many options as possible when they’re in the most severely ill state," Gifford says. "These options include access to and participation in clinical trials as a component of therapy, and so we thought it was a significant issue that African-Americans and Latinos were less likely to have access to these trials."
Overall, 14% of adults receiving HIV care participated in a medication trial or study and 24% had received experimental medications, according to the study, which was published in the New England Journal of Medicine on May 2, 2002. Investigators also found that non-Hispanic blacks and Hispanics were about half as likely to participate in trials as non-Hispanic whites.
Some of the reasons minorities may have less access to and participation in clinical trials include factors that concern perceptions on their part, as well as on the part of their clinicians, Gifford says. "If African-Americans and Latinos are less likely to access these therapies and trials, then it could be because the individuals themselves are suspicious, or confused by or less motivated to participate in clinical trials or to elect to use experimental therapies," Gifford says. "That’s certainly a possibility, and there are hints in the literature that that does indeed happen."
But there are alternative explanations, as well. For instance, it might be the physicians and people enrolling volunteers in clinical trials who carry biases or erect barriers to enrolling minority patients, Gifford says. "They may feel these patients are less likely to be good study subjects, such as coming back to appointments," Gifford explains. "Trials are expensive, and there’s a lot of money invested in each candidate who participates, and there are some who say — rightly or wrongly — that they believe certain types of patients are less likely to be reliable."
Patient selection slanted toward whites
So it’s possible that some clinicians carry unconscious bias against African-American and Latino HIV patients with regard to clinical trial participation. "We found evidence that both explanations are taking place," Gifford says. "We found that African-Americans and Latinos were less likely than whites to ever try to access experimental meds and get into a trial, suggesting they might be less motivated, less interested."
Researchers also found that when they limited their analysis to the people who were trying to obtain experimental treatments, they found a significant bias against African-Americans and Latinos to get the medications, Gifford adds. "The system’s selection of patients was slanted toward whites rather than minority subjects," he says. This means HIV clinicians and researchers need to work harder at expanding options for minority patients, Gifford says. "Those who participate in clinical trials are more likely to be on appropriate antiretroviral therapy, are more likely to be plugged into primary care visits, and are more likely to receive treatment for opportunistic infections," Gifford says. "So especially for those lower on the socioeconomic scale, participation in these clinical trials may be a way to access clinical services."
In an editorial published in the same issue as the study on participation in research, the New England Journal of Medicine states that physicians need to be aware of their own prejudicial attitudes toward minority groups and how these might influence their decisions about treatment.2 Patients, sensing these biases, may respond to the physician with mistrust and reluctance to adhere to treatment protocols, the editorial notes.
One strategy is for clinicians to build trust with their minority HIV patients, so that when the physician suggests a clinical trial, the patient will feel comfortable enough to ask questions and raise concerns. "I can’t think of a clinical decision that requires more patient education and consideration by doctor and patient than to participate in a clinical trial," Gifford says. "If nothing else, the best summary of the data we have is that trust is absolutely necessary between the person entering the trial and the investigator they are participating with."
It would also help to increase minority trial involvement if clinical trial centers were located in minority communities, Gifford says. "We found that people who are very close physically to a clinical trial center that does recruiting and is in the community are more likely to access clinical care and experimental medications," Gifford says. "This is one way to access minority communities, because it works: Place trials in minority communities or rent additional space in these communities where it can be more accessible physically to people."
Another change that would help remedy the situation is for HIV clinics and the HIV/AIDS community to do a better job of educating minority patients about clinical research and the ethical rules that clinical trials must follow, helping patients to better understand the risks and benefits of participation. This education should address some of the past research tragedies, such as the Tuskegee syphilis study, and explain how review boards and other safeguards now protect against such tragedies.
Clinicians also need to consider that there is a public health benefit to enrolling more minorities in clinical trials because it’s possible that certain populations may respond to drugs differently than others. If all research is done on whites, it’s only theoretical whether the effects would be the same for African-Americans or Latinos, Gifford says.
"Has clinical research been handled irresponsibly in the past? Yes it has," Gifford says. "But we have evidence that there have been very good and positive, responsible systems put into place to see that it doesn’t happen again, and I think we do a good job in general."
References
1. Gifford AL, Cunningham WE, Heslin KC, et al. Participation in research and access to experimental treatments by HIV-infected patients. N Engl J Med 2002; 346: 1373-1382.
2. Editorial. Racial disparities in clinical trials. N Engl J Med 2002; 346:1400-1402.
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