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.
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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.
“We’re hoping to start conversations with their physicians,” said Dr. Margaret Juarez, an obstetrician-gynecologist in the San Gabriel Valley who chairs the Network of Ethnic Physician Organizations representing more than 25 ethnic doctor groups statewide. “A lot of communities of color are not very trusting. But you will trust your physician who says there’s a trial out there or further testing that could benefit you or your family.”
Physicians can have “a major impact” in enrollment, said the FDA’s Bull, citing a recent study that found 77 percent of clinical trial participants learned about their trial from a health care provider.
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.
Some doctors may avoid bringing up the topic, either because they’re not fully aware of trial options, fear losing control over their patients or simply don’t have enough time in a rushed appointment to answer patients’ questions, Chen said.
In a 2014 study, UC Davis researchers found fewer than 2 percent of U.S. cancer trials were focused on patients who were not white. For every new cancer therapy that’s developed, “the gap for providing better treatment to minority groups is widening,” said Chen. “Since all people are not alike, there is insufficient assurance that the ‘standard’ therapy and the ‘standard’ outcome from those trials will be equally effective for all people, including minorities.”
Another factor, at least among some African Americans, is the unsavory saga of the decades-long Tuskegee syphilis clinical trial. Started in 1932, the Tuskegee trial was intended to show the negative effects of untreated syphilis in African American men, according to the Centers for Disease Control and Prevention. A total of 600 men – 400 with syphilis and 200 without – participated but were never fully informed they would go untreated, according to the CDC.
In 1972, after news reports revealed the study’s techniques, the trial was halted amid public outcry. The federal government agreed to a $10 million settlement and to provide lifetime medical care and burial benefits for participants and their immediate family. According to the CDC, the last Tuskegee patient died in 2004; the last widow receiving benefits died in 2009.
Culturally and historically, that legacy still resonates. “It was a long time ago, but it still has a lingering effect in this community,” said breast cancer survivor Denyse. “There’s a lack of trust in doctors. People may not be able to name the trial, but they’ll say: ‘Oh, no. You’re not going to use me as a guinea pig.’ ”
Denyse, who runs Carrie’s Touch, a support group for African American women with breast cancer, said she was “disheartened and saddened to learn the reasons why so few women of color were participating … fear, lack of trust, cultural myths.”
The lack of diversity in clinical trials is not a new concern, either at the federal or state level. It’s been on the radar of U.S. public health officials since at least the 1980s.
To boost more diverse enrollment, the FDA in 2014 launched “Drug Trials Snapshots,” a guide for consumers that catalogs drugs approved after clinical trials and how they vary in benefits and side effects by gender, race and age. Last year, more than 31,400 people participated in trials for 22 drugs treating a range of conditions. Of the participants, 76 percent were white, 48 percent were women, 11 percent were Asian and 7 percent were black.
Last year, then-FDA commissioner Dr. Robert M. Califf explained how a schizophrenia drug was found to have at least one side effect that was more common in African American patients. In another case, two types of blood pressure drugs were found to be less effective in black patients.
“These few examples,” he wrote, “show the importance of improving diversity in clinical trials, so medical products are safe and effective for everyone.”
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.”
And, he noted, clinical trial participants often get more attentive care. “There’s more monitoring, more accountability, more supervision. They’re monitoring the effects of therapy and the placebo so there’s more attention to the patient.”
Breast cancer survivor Denyse agrees, saying she got “top-notch treatment” during her Sutter Health clinical trial, which tested a two-drug therapy for pre-menopausal breast cancer patients. “Anything that came up, they answered my questions. I learned so much.”
Another clinical trial participant, Gracie Smith, is a retired Sacramento County employee who was diagnosed with lung cancer two years ago. Since starting a clinical trial offered last year by her UC Davis oncologist, she’s been getting a once-a-month drug infusion. Smith said her most recent imaging scans showed no signs of new tumors.
At 65, she has no doubts about continuing the clinical trial. “If it means I’ll be around longer with my family, that’s what I’m gonna do.”