Claudia Buck, Sacramento Bee, April 27, 2017
Getting diagnosed with cancer was “horrific” enough. But discovering that very few African American women like herself were enrolled in clinical trials to find a cure? That was almost as distressing for Tammie Denyse, a longtime breast cancer survivor in Sacramento.
After her Sutter Health oncologist offered her a slot in a clinical trial to test a new breast cancer drug treatment, the youth pastor carefully checked the study’s protocols for potential side effects. Then promptly signed up.
“The most important thing about being in a clinical trial is that I was giving back,” said Denyse, 52, a part-time pastor at Cho Un Korean United Methodist Church in Orangevale. By participating in a clinical trial, she gained an “opportunity as an African American woman to impact medicine … to know that this horrific cancer journey I was on was not in vain.”
Denyse, however, is not the norm. According to federal data, participants in U.S. clinical trials have historically been overwhelmingly white and predominantly male.
In a 2011 report, the Food and Drug Administration noted that blacks were 12 percent of the population but only 5 percent of clinical trial participants; Hispanics, at 16 percent of the population, represented only 1 percent.
By being underrepresented in clinical trials, women and ethnic minorities can be at a huge health disadvantage when it comes to finding the best treatments or cures for certain diseases, such as Type 2 diabetes, heart disease, cancers (colon, prostate, cervix, lung) and high blood pressure. Genetic differences mean that a drug or therapy that might work best in whites, for example, may not work well in, say, Latinos or Asians.
With diseases that disproportionately affect nonwhites and women, “You can’t determine what therapies will work unless they’re in a study,” said Dr. Jonca Bull, associate commissioner of minority health with the U.S. Food and Drug Administration.
Both in California and nationwide, renewed efforts are underway to get more diversity in clinical trials, where medical researchers follow rigid protocols in testing drugs, treatments and therapies on human volunteers. Currently, about 87,500 U.S. clinical trials are listed on the ClinicalTrials.gov website, ranging from AIDS dementia to excessive college drinking to rare diseases.
Last month, the California Medical Association Foundation and its ethnic doctor groups launched a statewide campaign to encourage more participation by diverse patients. The campaign features posters in doctors’ offices and short videos for patients that discuss the value of clinical trials.
So what’s keeping people away? It’s a combination of misunderstanding, fear, lack of awareness and financial and cultural barriers, say medical experts.
“It can be harder to recruit minority populations, but it does not mean Latinos, African Americans and Asians aren’t willing. They may not know of these trials,” said Dr. Sergio Aguilar-Gaxiola, director of the UC Davis Center for Reducing Health Disparities.
There also may be unconscious bias by researchers who find it more problematic to enroll diverse patients, particularly those with limited English proficiency, he added.
Sometimes the hurdle is simply confusing or misleading medical terminology, according to Dr. Moon Chen, a UC Davis cancer specialist and researcher who has studied the lack of diverse groups in cancer trials.
“If you’re a patient and don’t know what ‘clinical trial’ means, you might be thinking: ‘Does my doctor want me to be a guinea pig or take me to court?’” said Chen. “For a person who doesn’t know medicine, the words create an ambiguous and negative connotation.”
Time and logistics also can be barriers, he noted. A clinical trial can require more doctor visits, meaning patients need to leave work or arrange child care to get to appointments. Patients may also need to take additional medications or tests.
Last September, a new law lowering financial barriers for cancer clinical trials, Assembly Bill 1823, allows funds from public and private donors to help pay for travel, child care and other costs that might prohibit patients from joining a clinical trial.
The legislation noted a 2015 national study that found patient households making less than $50,000 annually were almost 30 percent less likely to participate in clinical trials.
That disparity “threatens one of the most basic ethical underpinnings of clinical research,” the bill states, “the requirement that the benefits of research be made available equitably among all eligible individuals.”
At UC Davis, several Alzheimer’s clinical trials are focused on ethnic differences. In one, a joint study by the UC Davis Alzheimer’s Disease Center and Kaiser Permanente Northern California, doctors are enrolling about 1,800 white, black, Asian and Latino patients older than 65. The study, according to UC Davis, is intended to fill in gaps from previous Alzheimer’s research that were based mostly on results from “highly educated whites.”
The benefits of clinical trials can be huge, say participants and physicians.
“If you want to help your next generation, people with your same genetic background, you have to participate in clinical trials,” said UC Davis’ Chen. “If you don’t, there is less representation or less opportunity for investigators to know whether (the drug or therapy) works.”