Clinical research is one of the most important — and least openly discussed — cornerstones of medicine. This type of research enables scientists to develop new medications, cures, and preventative measures for some of the most difficult diseases facing the human race today. Likewise, clinical trials give scientists an avenue to test new treatments and determine their safety and effectiveness before they go to market and are distributed to the masses.
As great and important as clinical research is, it certainly isn’t free from its fair share of sticky problems. Perhaps one of the most pressing issues in clinical research today is a significant lack of equal representation in clinical trials. The vast majority of clinical research is tested on middle-aged white men, meaning that the side effects of certain treatments on minorities and occasionally even women are pretty unknown. There are a plethora of reasons for this lack of representation. For instance, research studies typically focus on those who volunteer to participate. Historically, many clinical trials involving minorities crossed clear ethical boundaries, which has led to continued widespread distrust of the system.
Lack of Inclusion in Clinical Trials
Unfortunately, minorities have typically been left out of clinical studies altogether. Outside of a few notorious — and disturbing — examples of minority-focused clinical research, most studies have long been predominantly white — upwards of 80-90% white.
Part of this is because rigorous scientific experimentation has long required limiting the number of variables or demographic differences amongst test subjects. Doing so makes it easier to clearly prove that the medication is what is making the difference in outcomes. The obvious negative to this type of research is that once a medication hits the market, it will be recommended to thousands of patients of different ethnicities — many of which the medication was never rigorously tested on in the trial phase.
Congress took a step in the right direction in 1993 with the passage of the National Institutes of Health Revitalization Act. This required the agency to include more women and people of color in their medical research studies. Fast forward to the era of COVID-19 and most ethnicities were represented in medical trials in a proportionately appropriate way. That is, except African Americans.
Lack of Trust
There is no mistaking that a lack of trust in the health care system and in medical research is a significant part of why these disparities exist. In reality, this distrust is completely fair. There are plenty of examples of unethical medical testing throughout history. Some of the most notable ones include the Tuskegee Syphilis Study, where black men were deliberately left untreated for syphilis, or the Plutonium Trials, where participants were given injections of plutonium without an adequate explanation of the risks.
Today, many people argue over the ethics of cutting-edge research studies into things like nootropics or stem cell research. However, even some of the most common research studies lack willing minority participants. For instance, in many cancer studies, medical researchers struggle to garner interest in many minority patients.
The most heartbreaking aspect of this phenomenon is that participating in this type of research may be what saves the lives of many other minority patients in the future. Oftentimes racially and ethnically diverse patients suffer from health issues disproportionately to their populations. Recruiting for studies can be difficult because many do not have access — due to finances or other resource availability — to treatment facilities where the studies are taking place.
Breaking Down Barriers in Clinical Trials
The need to break down these barriers is immense. Not only can including more minorities in medical research studies produce better results for the entire population, but it can save lives in the long run. So the question then becomes — how do we start to break down these barriers and build more trust?
For many medical experts, the answer lies in building a relationship with patients. Earning the trust and respect of a patient through conversations and getting to know them as an individual is important. Even on a very basic level, they have to trust that a medical professional truly has their best interests at heart and cares about them as a real person.
Emphasizing the importance of personalized medical trials to increasing knowledge of how certain diseases and treatments impact minorities.
Improving access to medical information and trial opportunities at the local hospital level.
Expanding upon minority representation in healthcare career paths.
Providing educational materials that can help patients better understand the goals of medical research.
The value of medical research cannot be understated. However, there is a chronic lack of minority representation in the majority of clinical trials. Breaking down barriers that lead to a lack of inclusion and distrust in the system are important to improving the health of all patients. As a minority nurse, it is possible to play a pivotal role in starting to break these barriers down.
Last December, the FDA reported on both the Pfizer-BioNTech and Moderna Covid-19 vaccine and the respective race and ethnicity of their research participants in the Phases 2 and 3 research trials. The Pfizer trial included ages 16 or older and the Moderna trial included those 18 and older. Of 285 million in the United States population, over 40 thousand participated in the Pfizer trials and over 27 thousand in the Moderna trial. When looking at the combined totals of subjects compared to the general population, whites were found to be over represented. Whereas 73.6% of the U.S. population are white, 79.4% to 81.9% of the subjects reported their race as white. American Indian/Alaska Native and Native Hawaiian or Other Pacific Islanders had the exact percentage of research participants to those of the U.S. population; 0.8% and 0.2%, respectively. The second largest contrast in proportion of participants to the U.S. population was seen in comparing those of Asian race. Only 9.7-9.8% of research subjects reported themselves as Asian, whereas the total U.S. population percentage is 5.9%. The biggest discrepancy can be seen in research participants who reported their race as Black. Only 9.7-9.8% of research subjects were Black, whereas Blacks make up 12.3% the current total U.S. population. Regarding ethnicity, 17.6% of the U.S. population reports themselves as being Hispanic and 20-26% of participants identified themselves of Hispanic ethnicity. However, 82.4% of Americans report themselves as non-Hispanic and 73.2% to 79.1% of research subjects identified themselves as that ethnicity.
Despite these Covid-19 vaccine trials demonstrating greater diversity than previous trials of other pharmaceuticals, these statistics still represent a disparity in the representation of people of color as research participants in a vaccine designed to boost the immunity of a virus that is disproportionately affecting people of color in the United States.
The good news is that despite this disparity in the diversity of representation in the clinical trials, the findings did show that the safety and efficiency of the Pfizer-BioNTech and Moderna vaccines were similar across groups despite race. The question many pose in reaction to such statistics is why minorities are underrepresented in clinical trials. The main four reasons include: barriers to access, lack of information, and historical and continuous racism and discrimination. Barriers to access come in the form of few clinical trials being offered through under-resourced hospital systems that minorities use for health care. Also, minorities are less likely to have eligibility to participate in such trials due to having co-morbid conditions or not having health insurance. These attributes can exclude them from participation in such research studies.
Other challenges to access may be their limited or lack of transportation resources, being unable to request off of work, caregiving schedules, or not having access to technologies for monitoring during a research study. Some research studies have reported that physicians are less likely to offer clinical trial participation to minority patients. Enrollment efforts of research studies often may not reach the minority population if they are not culturally sensitive to address language or health literacy barriers. The history of medicine in the United States also has seen the abuse and mistreatment of minorities such as the Tuskegee syphilis experiment. As a result of such abuse and ongoing racism and discrimination, minorities are less willing to participate in clinical trials.
The racial and ethnic diversity of clinical trials in the further development of Covid-19 vaccines is imperative. This pandemic has impacted those of Black adults and minorities the most, so more trials should effectively recruit and maintain the participation of minorities. Minorities already historically have had lower vaccination rates and express more concerns about receiving the Covid-19 vaccine and perhaps their concerns are valid based on the data presented in this essay. Therefore, it is important that Covid-19 vaccine researchers ensure the safety and efficiency of the vaccine across all of the United States to increase the trust and confidence of minorities that they should get the vaccine.
According to HealthDay News, two recent studies in Africa have shown antiretroviral drugs are effective in preventing the spread of HIV in heterosexuals. The trials were conducted by the U.S. Centers for Disease Control and Prevention (CDC), with the help of the Botswana Ministry of Health, and the University of Washington’s Partners PrEP study.
HealthDay News says the most recent study done by CDC involved 1,219 HIV-negative men and women who were given either a daily dose of Truvada (a pill that combines tenofovir disoproxil fumarate and emtricitabine) or a placebo pill for 30 days. Additionally, all participants were given HIV prevention resources such as free condoms and risk reduction counseling. Results showed that those taking Truvada had a 62.6% risk reduction rate, increasing to 77.9% if the participant continued taking the pill after the trial.
The Partners PrEP study, conducted by the University of Washington and funded by the Bill & Melinda Gates foundation, was put to a quick rest due to its early indications that the pill prevented the spread of HIV, HealthDay News reports. The study included 4,758 couples with one HIV-positive partner. At random assignment, each couple received Viread (single drug), Truvada (combination drug), or a placebo. Results proved those taking Viread had a risk reduction rate of 62%, while those taking Truvada had a 73% reduction, compared to the placebo.
Kevin Fenton, Director of the CDC’s National Center for HIV/AIDS, says there is strong evidence of this prevention strategy within these two new studies. HealthDay News says the CDC will continue the use of antiretroviral drugs for those at risk for HIV.
On December 1 each year, you will find countries around the world commemorating World AIDS Day to raise awareness of the spreading of HIV infection. Each year, a theme is chosen for the campaign by UNAIDS. Starting in 2008, the World AIDS Campaign’s Global Steering Committee has chosen the theme, with the input from other organizations and government agencies. This year’s theme is “Getting to Zero,” which refers to zero new HIV infections, zero discrimination, and zero AIDS-related deaths this year.
One way to accomplish “getting to zero” is implementing vaccine trials, according to a release issued by GeoVax Labs, a biotechnology company located in Atlanta, Georgia, that creates and tests HIV/AIDS vaccines. However, a common problem many trials face is recruiting participants from at-risk communities. To reveal the reasons behind the lack of participation, researchers from the University of Toronto coordinated a study targeting nine focus groups made up of at-risk persons. In the end, the surveys exposed many misconceptions the individuals had regarding the vaccine trials. Recently, TheBody.com reported that many people do not take part in these trials because they believe it puts them at risk of getting AIDS, and they are skeptical of why the trials target people living in at-risk communities.
Gay and bisexual black men are one of the most susceptible populations and account for almost 25% of new HIV infections in the United States. The number of new infections overall has not changed significantly, with roughly 50,000 cases every year. However, vaccine developments and social initiatives are developed with frequency. A new $2.4 million campaign by the CDC was announced in November 2011, targeting gay and bisexual black men and encouraging them to be tested.
Female breast cancer is the most commonly diagnosed cancer among all races. Yet, mortality rates differ by race and ethnicity, and early detection numbers falter among minorities. Breast cancer is the second most common cancer death for all women, with the exception of Hispanics, where it is the #1 cause, according to Jacqueline W. Miller, M.D., F.A.C.S., of the Centers for Disease Control and Prevention (CDC). “There are so many variables when it comes to disparities,” she explains. “That is an issue, as you can’t see why there was a disparity, as there are so many other factors.”
Lillie D. Shockney, R.N., B.S., M.A.S., has seen much progress in breast cancer research in the 14 years she has been the Administrative Director of the Johns Hopkins Avon Foundation Breast Center in Baltimore, Maryland, a comprehensive, multi-disciplinary breast care program. There were assumptions for decades that minority women had higher mortality rates from breast cancer due to cultural reasons, she says. “What has been biologically determined is that the breast cancer does not behave in the same way in all races and ethnicities,” she says. “So for more minority women, even if we are seeing someone early-stage, we need to recognize that we need to be very aggressive with her treatment because the prognostic factors that her tumor has may present.” And not only could it present aggressively, the cancer may be more likely to recur as well.
Minorities, breast cancer research, and you
It provides credibility to studies if more researchers came from minority backgrounds, Shockney says. “If we’re talking to someone who is of Korean descent in one of our local communities, she is going to believe and trust someone of her own culture or ethnicity than someone who isn’t,” Shockney says. “That’s something that’s just instinctive, I think. It really isn’t meant in a malicious way.”
In fact, it is a golden opportunity for nurses from minority backgrounds to get into the research arena. “They have the opportunity to have their voices heard on behalf of not just nursing, but on behalf of patients and consumers,” Shockney says.
People of different races and ethnicities also need to be more represented as breast cancer study subjects. There are challenges getting people from all segments of society into clinical trials, says Yvonne Bryan, Ph.D., Chief of the Office of Extramural Programs at the National Institute of Nursing Research (NINR).
NINR, part of the National Institutes of Health (NIH), is the principle federal agency responsible for the support of nursing research. “Research priorities include promoting health and preventing disease, improving quality of life, eliminating health disparities, and setting directions for end-of-life research,” Bryan says. “Breast cancer is obviously a public health concern that intersects all of these priorities.”
NINR has found a promising approach—community-based participatory research, or CBPR—to increase involvement throughout society in the design and implementation of studies. “It really requires a relationship between the community and the academic researcher…to play an active role [together] in the research process from A to Z,” Bryan explains. “That means study conceptualization, design, participant recruitment, and retention, analysis, and dissemination.”
NIH is one of several organizations supporting the community-based participatory research of Karen Williams, Ph.D., an assistant professor in the College of Human Medicine at Michigan State University. Using this method of research, Williams designed a breast and cervical cancer intervention called the Kin Keeper. The program helps African American women receive potentially life-saving health care information in their own home with family support.
“Her program has shown that African American women’s strong family bonds have reinforced information sharing to increase cancer literacy and as well encourage participants to follow through with mammograms and other cancer screening and procedures,” says Bryan, a native of Jamaica who also studied nursing in her homeland. The Kin Keeper curriculum has been translated into Spanish and Arabic, bringing this preventive health care information and support systems to other populations in the United States that often experience health disparities, Bryan adds.
Bryan also points to two other studies by NINR-funded researchers involving minority subjects, including “The African American Breast Cancer Survivorship Program,” led by Kathleen Dwyer, Ph.D., R.N., of the University of Oklahoma College of Nursing. Dwyer’s team is examining the impact of breast cancer treatment completion on the physical and emotional quality of life of African American women who have survived the disease. Participants learn coping and support strategies to readjust to life after treatment.
A NINR-supported study completed in 2002, conducted by Marylin Dodd, Ph.D., R.N., F.A.A.N., and Noreen Facione, Ph.D., R.N., F.N.P., F.A.A.N., of the University of California at San Francisco, found some factors that contribute to a delay in reporting self-discovered breast cancer symptoms can be racial or ethnic. “Among both Latina and black women [it] included low-income and lack of health insurance, lower education, and poor breast cancer knowledge,” Bryan says. “The study concluded that decreasing the delay in reporting symptoms could help reduce breast cancer mortality in minority populations.”
Through the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), the CDC is providing low-income, uninsured, and underserved women access to breast and cervical cancer screenings, diagnostic services, and treatment referrals. For breast cancer screenings, women must be between the ages of 40 and 64. Between 8% and 11% of U.S. women of screening age are eligible to receive the program’s services. To be eligible for the program, women must be uninsured or underinsured and at or below 250% of the federal poverty level.
The NBCCEDP funds breast and cervical cancer programs in every state, the District of Columbia, five U.S. territories, and 12 American Indian/Alaska Native tribes or tribal organizations. Five of these programs are in Alaska and seven are on American Indian tribal programs, found in six states stretching from Washington to Alabama. “Within their own tribes they don’t typically have a lot of resources. Having health care services, including screening services, is a challenge,” according to the CDC’s Miller. Researchers also face reluctance among some Native American women when it comes to seeking traditional Western treatment.
A CDR with the U.S. Public Health Service, Miller has been a medical officer with a focus on breast cancer epidemiology, prevention, and early detection since 2004. One of her concerns is the alarming frequency with which minority women get breast cancer at a young age. Native Americans, for example, are often diagnosed with breast cancer at a younger age than other groups, Miller says. “Of course they have a higher risk factor because they have the reservations with casinos, and smoking and alcohol drinking are sometimes pretty high on reservations.”
African Americans and Ashkenazi Jews also have a higher risk of having breast cancer as younger women—in their 40s—than older women. Triple-negative breast cancer is a somewhat newly recognized form of breast cancer, often found among young 40-something African American women, according to Miller.
Women with deficient levels of estrogen, progesterone, and HER2 receptors—the characteristics of triple-negative breast cancer—may not respond to treatment as readily as others. “If you have estrogen [and] progesterone…that means you can respond to certain types of medication better,” Miller says. Research in this area is in the early stages.
The Early Detection Program also collects data to better understand the groups it serves. Researchers record when women come in for screenings, and how long it takes to get a mammogram and then reach a diagnosis. When patients have breast cancer, the CDC looks at the time elapsed between diagnosis and treatment. “We monitor it so we make sure that we have quality insurance and quality improvement,” Miller says. “We don’t want someone to come in with an abnormal mammogram and it take nine months before someone sees her. We have to make sure that they get timely, quality treatment.”
The Early Detection Program works in conjunction with national organizations, state health agencies, and other groups that help to develop, implement, and promote effective cancer prevention and control practices. These partners lead programs and outreach, putting “research findings into action in order to achieve mutually beneficial goals,” the CDC reports. Not all partners receive CDC funding.
Having nurses from minority groups could help reduce some disparities. Nurses are often the first people patients turn to with questions about their diseases, says Miller, who is African American. Nurses also help patients navigate the system. “Problems arise from lack of communication, and nurses really play a major role in making those reminder systems and in education,” she says. “I think all nurses can do that.”
Miller said she believes minority populations are fairly underrepresented in a lot of research today. “That’s one big push right now with clinical trials—to make sure we get more minority patients involved.”
Facing disparities head on
Minority nurses also play a key role in battling breast cancer in the clinical setting. Andrea Smith, R.N., B.S.N., has worked at the Evelyn H. Lauder Breast Cancer Center of the Memorial Sloan-Kettering Cancer Center in New York City for the past two years. An office practice nurse, she works one-on-one with the treating physician as part of the consultation team.
“I try my best to work one-on-one with the physician so I know what’s going on with each one of my patients, whether it is treatment or diagnostics,” Smith says. “I try to stay as well informed as I can because they call me first and then they speak with the physician if necessary.”
The New York City center provides comprehensive breast cancer prevention, diagnostics, treatment, and support services all under one roof. Memorial Sloan-Kettering Cancer Center conducts one of the largest programs of clinical research in the world. In breast cancer, that research encompasses surgery, radiation therapy, chemotherapy, imaging techniques, and genetics.
Smith is one of approximately 20 office practice nurses in the 16-story center. “I like working with women and specifically [those with] breast cancer,” she says. “I find it interesting.” And new breast cancer research and treatment options come out all the time.
Smith says she’s seen an increase in the number of breast cancer studies offered and patients registered, and women are becoming more aware of the benefits of early detection. However, patients from minority backgrounds are still lagging behind in screenings. In 2005, black women, when compared to non-Hispanic white women, were 10% less likely to have been diagnosed with breast cancer. Black women were also 34% more likely to die from the disease, according to a February 2011 report featured by the AARP.
“When I speak to patients, minority patients, they will give me their own story,” Smith says. “They might tell me that either they didn’t have the right type of insurance or did not know that they should go get screened because they didn’t have the knowledge or education regarding it.” Many of these patients grew up not seeing a physician regularly for well visits. “They say, ‘My parents never really ingrained that in me, going to a doctor, going to get check ups,'” Smith says.
Smith says many of those patients focus on the immediate future; acute situations prompt them to seek care, but preventive measures often are not taken. “It’s a lot of different things, but I think that’s the majority of reasons that you don’t see a lot of minorities going to the doctor is that they just don’t feel comfortable about it or they don’t have the right type of insurance. They can’t go if they can’t afford it, and free clinics don’t offer anything, very little.”
Many people from minority groups tend to be religious, Smith notes, and that can impact the way they think about health care. They may think, “God will take care of me. I really don’t need to worry about those things,” Smith says.
In turn, community outreach in churches may be an effective way to educate women and men about breast cancer. “People go to church,” Smith says. “That’s where they get a lot of their information. I think that would be one good place to start.” Community centers could also be a good venue to reach minority populations, she adds. “You need to get to where these minorities congregate, and I am not just talking about African Americans,” Smith said. Depending on the community, a lack of access to the Internet and cable television, which may advertise local health care resources, can also be an issue.
Minority nurses can also be effective when addressing patients from similar backgrounds. “A lot of times too, it’s about relating to people. It can be an issue such as hair loss due to chemotherapy….It’s not the same for Caucasian women as it is for African American women,” Smith says. “Very simple things like that can be where they may feel more comfortable having a nurse who they can relate to.”
The ins and outs of oncology nursing
Myrielle Whittle, B.S.N., R.N., is a clinical nurse who works in the outpatient oncology and hematology clinic at Beth Israel Deaconess Medical Center in Boston. A registered nurse for more than 30 years, Whittle made the move into oncology early in her career. Today more than half the people she sees are breast cancer patients. “They come to me after they’ve been diagnosed with a mammogram or have been through surgery,” says Whittle, a native of Haiti. “By the time they get to me, it is for what is called complementary chemotherapy with their surgery, or they may be getting radiation. It is usually two or three weeks after they’ve had their breast surgery. I explain to the patient what chemotherapy is, what their medications are. I’m the person who oversees all of that,” Whittle says. “If a patient has any symptoms or questions or concerns, it usually goes to the office practice nurse first.”
Working with breast cancer patients in an outpatient setting is a challenge, Whittle admits, but one that she embraces. “When people are in the hospital, they stay for three to five days. In outpatient you only have maybe two or three hours to use the resources you have to help them manage their pain. In ambulatory oncology, it’s more than just administering a drug….I feel like a point guard in helping them.”
Each patient has individual needs, whether it is managing a job, applying for disability stipends, or paying for chemotherapy treatments, as well as more mundane tasks, such as arranging transportation to the clinic. Whittle often helps patients manage these aspects of their lives. “There’s a lot I get involved in,” she says.
When it comes to breast cancer, the patient-nurse relationships can also be long-term. “After they get diagnosed, it can be a six-month process where I see a patient maybe once a week. You do build up a relationship with them,” Whittle explains. “From that you find out what is and what isn’t working for them for managing their pain. It’s not just sticking an IV in and giving them a drug and sending them on their way.”
Yet, for all the happiness that comes with seeing a patient through to remission, oncology nurses must also prepare for the inevitable bleak diagnoses— losing patients after bonding with them over long-term treatments. Fortunately, even when a patient’s breast cancer is not curable, they often survive for many years. “It’s [about] management,” Whittle says. “I’ve had patients who have had it for 15 years. I see them on a regular basis and in that course of time a lot of issues come up. Ambulatory care is very different and very challenging, but it’s very rewarding at the same time. I get to have a relationship with my patients and I love that feel. I become like part of their family.
“With oncology, they have new research and drugs that they didn’t have four or five years ago. People may think, ‘Oh everyone in this [area] dies.’ While that may be, we can help someone graduate from college and it’s nice to see.”
While Whittle says she sees many Asian and African American patients, she calls cancer thegreat equalizer. “Breast cancer does not differentiate, but sadly sometimes socioeconomic status affects diagnosis,” she says. “I think overall we are making progress with breast cancer. Every year people are getting diagnosed at an earlier stage. When people are diagnosed at stage 1 and stage 2 instead of stage 3 or 4, there is a much better outcome.”
Research has changed the way patients are treated over the years. “The way I treated patients four or five years ago may not be the same today,” Whittle says. “I’m not a ‘research nurse’ but I do participate in research. We have a patient on a clinical trial and I administer the drug.”
And when you approach the work with passion, you truly make a difference, regardless of where you work or whom you’re treating. “It sounds corny but it’s one of those things where everyday you feel like you’ve made a difference in somebody’s life, and as a nurse you do. Sometimes it’s just holding a patient’s hand or just listening to a patient,” Whittle says. “Nursing is a science and it’s an art; there’s a lot they don’t teach you in nursing school, but if you like it, and you are a people person, you learn. I just love being a nurse. I encourage anybody who is considering that position to go for it. I feel grateful everyday and appreciated by patients and their families.”