Enrolling Minorities in Cancer Clinical Trials is a Challenge — with Solutions
For decades, African Americans have been underrepresented in the clinical studies that lead to approval of new cancer drugs. The reasons for this well-known problem are many.
But an analysis of data recently made available by the U.S. Food and Drug Administration shows that it may not be getting better — not even in trials of drugs for cancers that disproportionately affect African Americans.
ProPublica, the nonprofit investigative news site, found that in trials for 24 of the 31 cancer drugs approved in 2015, fewer than 5 percent of patients were black, even though more than 13 percent of the U.S. population is black.
The analysis, co-published with Boston-based health news site STAT, cited the example of Ninlaro, approved in 2015 for the blood cancer multiple myeloma. Of 722 patients in the pivotal trial, only 13 — 1.8 percent — were black. Yet black people are twice as likely as whites to be diagnosed with the blood cancer.
This persistent disparity means that black patients aren’t getting early access to potentially life-extending drugs, and possible differences in their responses to drugs are going unstudied, according to experts quoted in ProPublica’s analysis.
Some Philadelphia experts echoed their concerns.
“Not enough attention is given to this problem,” said Kevin Kelly, an oncologist at Thomas Jefferson University, who has spent 30 years conducting clinical cancer trials. “There are several clear causes, and a lot of causes we don’t know.”
Among the recognized barriers: logistical challenges of getting to a trial site, financial limitations, and distrust of the medical community rooted in infamous historical experiments such as the Tuskegee syphilis study, in which black men were left untreated for decades so scientists could observe the course of the disease.
But with concerted efforts, many barriers can be broken down, Kelly said. That’s why big clinical trial networks, which coordinate studies at academic medical centers, have higher minority enrollment rates than industry-sponsored trials.
At Jefferson, for example, about 19 percent of trial participants are minorities — a fraction that is reasonably close to reflecting the city’s 25 percent minority population, Kelly said. All new Jefferson cancer patients are pre-screened to see whether they are eligible for any studies, so the idea of participation can be discussed early in treatment.
“We monitor the sex and racial balance in trials and make sure we are targeting minorities,” Kelly said, adding that educating people on the clinical trial process is key.
Fox Chase Cancer Center has several programs dedicated to educating minority groups about the complexities of trials, including the informed consent process and the ethics review board that approves the study protocol, said Evelyn
Gonzalez, director of the office of community outreach.
In addition to a bilingual speakers’ bureau that provides free cancer information sessions to community groups, Fox Chase has a new “community ambassador” program. So far, it has trained 18 lay people to lead educational sessions at churches and social organizations.
“I would say the primary barrier to participation is a general lack of awareness that clinical trials are even an option,” Gonzalez said. “Because of the media, the words clinical trial are not foreign. But there is still a lot of mistrust and misconceptions.”
Article written by: Marie McCullough, TNJ