By Victoria Colliver
As a nurse practitioner, Phyllis Howard understands the value of clinical trials in testing new drugs or treatment protocols. But as an African-American woman, she was leery about the idea of being a test subject.
“I considered it being experimented on,” said Howard, 56, of her initial reaction to a suggestion by her UC San Francisco oncologist that she enroll in a clinical trial shortly after her 2009 breast cancer diagnosis.
The trial was designed to test the benefit of a new chemotherapy regimen, but, she said later, a historic mistrust many African-Americans have of medical research was at play, rooted in the Tuskegee experiment, an infamous trial conducted between 1932 and 1972 in which the U.S. government tracked the progress of untreated syphilis in rural black American men.
Howard ultimately got past her hesitation.
“If we don’t find a way to let ourselves be part of research, we’re going to be left out,” she said.
Medical and drug industry players are increasing trying new ways to reach out to underrepresented groups, including African-Americans, Asians and Latinos, to let them know the benefits of participating in medical research.
It’s important that enrollees in clinical trials reflect the overall population because the way people respond to drugs may be affected by biological differences linked to race and ethnicity. Nationwide, trials don’t reflect that diversity.
For example, Latinos make up 16 percent of the U.S. population, but only 1 percent of clinical trial participants, according to the U.S. Food and Drug Administration. African-Americans represent 12 percent of the population, but participate in trials at a rate of just 5 percent. Asians account for about 5 percent of the U.S. population, but make up just 1 to 2 percent of those who enroll in trials.
Diversity needed in trials
But statistics show why it’s important to have far more diversity among participants in clinical trials to develop new medicine and treatments.
Black men are twice as likely as white men to die from prostate cancer, but make up only 5 percent of prostate cancer trial participants. Americans of Mexican and Puerto Rican descent have more the double the prevalence of diabetes, but are underrepresented in trials involving diabetes research.
“If people who don’t look like you aren’t in clinical trials, when the time comes we’ll be playing Russian roulette with your health because we don’t have the science,” said Dr. Gary Puckerin, president and chief executive officer of the National Minority Quality Forum, a Washington, D.C., nonprofit group that advocates for improving health quality in diverse populations.
Aside from mistrust, other barriers to trial enrollment by underrepresented groups include lack of English-speaking skills, unfamiliarity with what clinical trials are, and cultural differences around such issues as donating blood or tissue samples.
The health industry, including hospitals and pharmaceutical companies, has initiated several new efforts to change the imbalance.
This spring, the National Minority Quality Forum teamed up with the drug industry’s trade group, Pharmaceutical Research and Manufacturers of America, to start a new educational campaign nationwide called “I’m In.”
“Any increase in terms of diversification will be a big success because the situation is so bad,” said Dr. Salvatore Alesci, vice president of scientific and regulatory affairs for the pharmaceutical trade group.
In a UC Davis study published in March, researchers looked at more than 10,000 federally funded cancer clinical trials and found that less than 2 percent focused on any specific racial or ethnic group. Less than 5 percent of all U.S. trial participants are nonwhite, they found.
“The two fastest-growing minority groups — Latinos and Asians — are experiencing cancer as the leading cause of death,” said study leader Moon Chen, associate director for cancer control at UCD’s Comprehensive Cancer Center. “If we want to experience the benefits of clinical trials, we need to increase the effort to recruit more Asians and Latinos into clinical trials.”
In April, UCD started a program that reaches out to every Asian patient diagnosed at the center with cancer to offer individual education in Asian languages including Vietnamese, Chinese, Korean, Tagalog and Hmong. The university is considering expanding it to other population groups.
For now, the program encourages Asian patients to participate in an UCD study to learn about biological differences among the patients that may require different treatments. It requires each patient to provide blood, saliva, tissue and other biospecimen samples.
In focus group surveys in advance of the study, some Chinese and Vietnamese respondents told researchers they feared that taking their blood would affect their energy or allow diseases to be introduced to their bodies. The researchers learned that emphasizing that trial participation would help future generations resonated with Asian survey participants.
Faith and understanding
Dr. Ho Tran, founder and president of the National Council of Asian Pacific Islander Physicians in San Francisco, said Asian patients generally have great faith in authority figures like doctors, but often struggle with understanding why their doctor wouldn’t just give them the best medication.
“They don’t all understand the word ‘trial.’ They think, ‘Why are you giving me a medication that doesn’t work?’ ” Tran said.
Unlike many in the focus group, Changsun Zheng, 79, a UCD patient who was diagnosed with late-stage cancer, was never resistant to the idea of donating tissue, and it turns out the information from his biopsy has helped save his life.
His biopsy showed he had a specific mutation, called epidermal growth factor receptor, that is found in much higher percentages in Asian patients than the general population. The mutation, which tends to be more common in nonsmokers like Zheng, also means the tumors respond better to drugs that target the mutation.
Based on the information gleaned from his biopsy, he was placed on the targeted therapy. But when Zheng started experiencing weight loss and other strong side effects, his oncologist, Tianhong Li, immediately knew what was wrong: His dose was too high.
“In Asian people, our enzymes are different,” Li explained. “The same dosage in an Asian patient, the plasma level is higher so we are better on a lower dose. Because of this knowledge, I reduced the dose.”
As a result, Zheng has been able to tolerate the drug, which keeps his cancer at bay.
Zheng, who thought he just had months to live when he was diagnosed in 2012, said through an interpreter that he’s grateful.
“I feel very lucky,” he said. “The right doctor gave me the right treatment plan. I am very confident I can live longer.”
Not all health organizations have trouble with ethnic imbalances in their clinical trial programs.
Kaiser Permanente’s cancer clinical trial participation closely matches Northern California’s population, said Dr. Louis Fehrenbacher, medical director of the oncology clinical trials program for Kaiser Permanente in the region.
Forming a connection
Asian Americans in Northern California accounted for 12.4 percent of Kaiser’s cancer patients and made up 15.1 percent of its trial enrollees in 2012, Fehrenbacher said. For African Americans, those numbers were 7.6 percent and 7 percent respectively, and for Latinos, they were 9.4 percent of patients and 10.4 percent of trial participants.
Fehrenbacher didn’t have an easy answer to why Kaiser’s experience is different from other medical institutions, but noted that Kaiser members have typically been in the system for many years, making the trust issue less of a problem. He said Kaiser participates in later-stage trials when safety has already been tested.
For Howard, who has been cancer free since her diagnosis five years ago, the experience of participating in a UCSF trial has given her the opportunity to speak to her own patients as well as others about her experience.
“In order to get more people of color open and willing to participate, you have to have somebody who looks like them. And you have to have somebody who’s been there,” Howard said. “I may not personally gain from this, but somebody coming from behind me might.”
— Reach Victoria Colliver at [email protected]