Willingness to participate in trials varies by race
Non-Caucasians more suspicious of true intent
Non-Caucasian cancer patients, while just as interested as Caucasian patients in learning about clinical trials, approach their decision to enroll in one differently, according to new study.
They tend to talk to family, friends, and other patients while considering enrollment rather than looking to sources such as the Internet. They are less likely to sign up for a trial unless the chances are high that they’ll benefit from it.
And non-Caucasian patients are more than twice as likely as whites to believe that they have been treated as part of a clinical trial without their knowledge — likely a legacy of the infamous Tuskegee study that ended in the 1970s, says the study’s lead author, Charles Wood, MD, a radiation oncologist at the Hospital of the University of Pennsylvania in Philadelphia.
Wood presented the study in October at the annual meeting of the American Society for Therapeutic Radiology and Oncology.
He says the challenge for investigators and IRBs is to recognize the differing attitudes of white and nonwhite patients and to address them, particularly during the informed consent process.
"I think it’s our responsibility to get better," Wood says. "We think we communicate much better with patients than we actually do. If this is going to improve, it’s not going to be making the non-Caucasian patients change their attitudes. It’s going to come from us."
He also noted that patient-to-patient networks that allow prospective participants to talk to patients who already are part of a clinical trial could be helpful in recruiting minorities.
Wood’s group surveyed 166 cancer patients over eight months in 2003 at two radiation oncology clinics regarding their attitudes toward clinical trials. Patients ranged in age from 15 to 84. The most common cancer diagnoses were breast, prostate, and head and neck cancers.
Wood says that his study didn’t initially focus on race, but looked at a variety of factors, including gender, age, and the differences between patients at the two clinics — one a Veterans Affairs hospital and another at the University of Pennsylvania.
But it was the attitudes expressed by patients of different races that became clear in analyzing the data, he says:
— While both groups showed about the same interest in learning about clinical trials, Caucasians were more likely to seek out more information from the Internet (31% vs. 11% for non-Caucasians) or from their doctors (50% vs. 34%).
— Non-Caucasians were more likely to talk to other patients about enrolling in a clinical trial (25% vs. 12% for Caucasians).
— Minority patients were more likely to feel that they would need a better than 50% chance of benefiting from a clinical trial to agree to it (64% vs. 45% for Caucasians). Both groups, however, had similar expectations regarding potential side effects from the treatment.
— Non-Caucasian patients were more than twice as likely as whites to believe they had been treated in the past in a clinical trial without their knowledge (22% vs. 9%).
That last statistic leapt out at the researchers, Wood says. "We put the question there almost as an afterthought because we didn’t think we’d get much of a response. And that was when our jaw dropped."
Trust not inherent
Wood, who is Caucasian, says he believes the attitude expressed in the question relates directly back to the U.S. Public Health Service’s Tuskegee syphilis study, in which black male patients in Alabama were enrolled in a 40-year study to examine the effects of syphilis.
The men enrolled in those studies weren’t told they had the disease or given effective treatments for it. The study ended in 1972, after word of it was leaked. Patients’ families sued, and won a $9 million settlement. In 1997, President Clinton formally apologized to the victims.
Wood says the effects of the notorious study still resonate in the minority community decades after it ended. Knowledge of the Tuskegee study combine with conspiracy theories about other public health threats — AIDS, drug addiction, Agent Orange — to create a deep well of distrust that doctors may not be aware of, he says.
"We have the expectation that trust for us on the part of the patient is inherent — that they’re automatically going to trust us because we are their doctor," Wood says. "We need to understand that we are not automatically trusted and at least according to this question, [some of the time], we are not trusted at all."
He says if researchers know that mistrust exists, they can work to overcome it, and that an understandable, unpressured informed consent process can be a key tool in doing that.
"The non-Caucasian patient sees [informed consent] as a legal loophole for the physician to be protected, regardless of how he acts," Wood says. "I think when you go before the IRB board, they should put a lot of emphasis on the consent form being educational to the patient — explaining in very basic language why they’re doing the trial, what you could get out of the trial, and how the trial might hurt you. I think the IRB is a crucial step."
Wood says patients shouldn’t be pressured to sign the form immediately, but encouraged to take it home and discuss the clinical trial with friends, family, and community members.
He’s unsure how to address the finding that non-Caucasian patients want a higher chance of benefit from a study.
"It’s not like you can make any guarantees in the trial," he says. "You shouldn’t put any more emphasis on the positive vs. the negative. Just have the knowledge that non-Caucasian patients expect more from the trial."
Wood advocates for an organized patient-to-patient contact that would allow people considering a clinical trial to talk to those already in it. Patients interested in being contacted could give consent to have their names released.
"Patients trust other patients, perhaps more than they trust physicians, because the patient’s interest is in getting well," Wood says. "A patient might think the physician’s interest is financial, or fame, or any number of other things. I think a patient-to-patient network would just be a huge help."
Most importantly, Wood says, researchers and IRBs need to place the burden of overcoming attitudes such as those identified in this study squarely on themselves. "We’re targeting ourselves because we’re just not getting the job done."