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Changing the Face of Clinical Trials

Efforts are under way to increase African-American enrollment in cancer clinical trials. By Leslie Harris O'Hanlon

When Douglas Alexander’s prostate cancer showed signs of re-emerging after years in remission, he didn’t have any viable treatment options available. The radiation therapy he’d had when he was first diagnosed with a stage I tumor five years earlier couldn’t be repeated, and surgery also wasn’t an option: Despite rising levels of prostate-specific antigen (PSA), which suggested Alexander’s cancer had returned or spread, his doctors couldn’t find a new tumor on medical scans. So when his oncologist told him about a pilot study testing a cancer vaccine in patients at the National Cancer Institute (NCI) in Bethesda, Md., just 25 miles from his home in Bowie, Md., Alexander, now 63, readily agreed to participate.

That decision made him a bit of a rarity: an African-American in a clinical trial.

Finding Clinical Trials
Locate trials seeking African-American participants.
Overall, only about 5 to 10 percent of cancer patients participate in clinical trials. And when it comes to African-American cancer patients, the figures are even lower: 2 to 4 percent. This low participation makes it difficult for researchers to get answers to critical questions: Why are African-Americans more likely to develop certain cancers than other racial and ethnic groups and have higher death rates for some types of the disease? Is it lifestyle? Genetics? Treatment response? Access to health care? No one yet knows. But researchers believe that increasing the number of African-Americans in cancer trials will help them find out. So that can happen, more efforts are under way to identify the reasons that so few African-American cancer patients join clinical trials—and to implement programs that can put them on the clinical trials track.

Questions and Concerns
Increasing African-American participation in clinical trials requires a focus on issues ranging from their potential questions and concerns about the studies to how and when doctors discuss clinical trials with their patients. One known problem is that many African-Americans have historical reasons to distrust the clinical trials system—a legacy of the infamous government-sponsored Tuskegee study in which several hundred poor African-American sharecroppers in Alabama were intentionally not treated for syphilis because researchers wanted to study how the disease naturally progresses.

Nikita Robinson, a senior research coordinator at the M. D. Anderson Cancer Center in Houston, Texas, says that even though Tuskegee happened decades ago, it still comes up in her conversations with African-American patients, especially older ones, when she tries to recruit them for clinical trials. “I tell them that … those things don’t happen anymore,” she says. “Research is controlled now. It’s governed by review boards. [Researchers] can’t just do whatever they want.”

Another challenge relates to health issues. African-Americans are often more likely than other groups to have chronic health conditions, like hypertension and diabetes, which may make them ineligible for clinical trials. Including patients in trials with these conditions—which doctors refer to as “comorbidities”—makes it harder to assess the toxicity of a new drug, explains Lauren Wood, an immunologist at the NCI and the lead investigator of the trial that enrolled Alexander. “One of the problems the research community is trying to address is how to design clinical trials that allow individuals who have [other health problems] to still have access to these new treatments.”

“It’s important to have a voice, and our voice can be through clinical trials.”
Lower participation isn’t only a result of patients choosing not to join or being ineligible. Studies have found that physicians do not discuss clinical trials with their African-American patients as often as they do with their white patients. “Physicians might feel that some [African-American] patients will not be able to understand the consent process or have the ability to adhere to the protocol,” says Susan Eggly, a communications scientist at the Karmanos Cancer Institute at Wayne State University in Detroit who studies patient-physician communication. “They also might presume that patients will be unwilling to participate.”

At M. D. Anderson, Robinson, who is African-American, tries to help minorities understand why their involvement in trials matters. “It’s important to have a voice,” she says, “and our voice can be through clinical trials.”


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