“I’m the first person in my circle of family and friends to participate in a clinical trial.”
Five years ago, Rhonda Long was diagnosed with cholangiocarcinoma, a rare bile duct cancer that’s seen in only about 8,000 Americans each year.
At the time, Long, who is Black, said her doctor in Dayton, OH, told her she was not a candidate for surgery and suggested palliative care. After seeking a second opinion at Duke University Medical Center, where her sister worked, the 51-year-old wife and mother of two had surgery, radiation, and chemotherapy there in North Carolina. When the chemo stopped working after 3 months, her oncologist at Duke referred her to a colleague at Massachusetts General Hospital, where she was accepted into a clinical trial.
“In 2019, I traveled to Boston from Dayton, Ohio, every 3 weeks for labs and scans, to make sure that the drug wasn’t doing more harm than good, making sure that the drug as developed was maintaining, shrinking, or even eliminating the disease. Physically and financially, it takes a toll on you and loved ones.”
Her medical insurance did not cover the direct expenses from the clinical trial, and she was spending $1,000 to $1,500 each trip. Sometimes they drove the 15 hours to Boston, and sometimes they flew on the cheapest flight they could find.
It’s not an unfamiliar story: people traveling, often long distances, to take part in clinical trials they hope will save their lives.
The Lazarex Cancer Foundation of Danville, CA, helped Long do just that.
Marya Shegog, PhD, health equity and diversity coordinator at Lazarex, says a patient travels an average of 500 miles to participate in a trial.
The financial hurdles often prevent patients from taking part in clinical trials, Shegog says. “When you are sick, and you have a disease that may be terminal, you start thinking about setting your things in order,” she says.
Many patients have to make a decision.
“Do I bankrupt my family on trying and hoping that this drug works and helps me live longer, or do I start setting things in order so that when I’m gone, they’re OK or at least better than if I wouldn’t have spent all the money traveling back and forth.”
Shegog, a 17-year cancer survivor, says when she was battling cervical cancer, a clinical trial was never offered or explored.
Lazarex has been helping cancer patients who have run out of options for 15 years. It identifies clinical trial opportunities and reimburses patients for all travel costs. Last year, Lazarex reimbursed more than 1,000 cancer patients. And it has supported to more than 6,000 people since opening its doors.
“Lazarex exists to help remove the barriers of people not being able to participate in trials,” Shegog says. “It’s systemic that the medical system does not treat patients the same and oftentimes does not offer or make aware the opportunities for African Americans to participate.”
But now, thanks in part to COVID-19, new possibilities are taking shape. The pandemic has changed the landscape for trials, forcing many of them to go virtual, which allows patients to schedule telehealth visits and get some services like bloodwork and CT or MRI scans closer to home. Long’s trial eventually went virtual.
“It was absolutely fantastic,” she says. “Having the trial locally, it saves us money, it saves wear and tear on my body. Being in the car, being in an airport or in a plane and in a hotel, all of that wears on you physically.”
The move to virtual studies may have lasting effects on research and treatment.
“The current pandemic has forced us to reexamine all of the traditional burdens we place on patients as it relates to receiving cancer treatment,” said Hala Borno, MD, an assistant professor of medicine at the University of California, San Francisco. “Whether they’re coming to our health care facility to see a clinician, for diagnostics such as blood draws and scans, or to receive therapy, this pandemic has challenged us to explore other possibilities that minimize the risk of exposure to SARS-CoV-2. What I find striking is that it has helped us operationalize use of telemedicine and the delivery of care closer to home.”
This is especially encouraging news for minority patients whose participation in trials has for years lagged well behind that of whites.
But travel is not the only reason. Racial disparities in clinical trials have long been an issue that’s just another part of the implicit bias in health care.
And it’s not just African Americans. Asians, Hispanics, Native Americans, and Alaska Natives are all underrepresented in trials at a time when there is growing evidence that drugs may have different effects on different populations.
Borno is an oncologist who specializes in prostate cancer, a disease that she says shows a “significant disparity,” where Black men are 2 times more likely to die from advanced prostate cancer compared to white men. Yet Black men make up just 3% of advanced therapeutic trials.
“A lack of diversity and inclusion in clinical trials is unacceptable,” she says. “If we continue to under-recruit racial/ethnic minorities and older adults to therapeutic clinical trials, we will not be powered to make valid conclusions regarding safety and efficacy in those patient populations. As a result, we can do harm.”
Borno says telehealth and telemedicine are not cure-alls, and digital health solutions don’t work for all patients. Approaches, she says, must be tailored to the individual, or disparities could worsen.
In 2020, the FDA approved 53 new drugs. Overall, 32,000 patients took part in these trials. On average, 75% were white, 8% were Black, 6% were Asian, and 11% were Hispanic.
Here’s one stark example of the issue. In 2015, the FDA approved ixazomib (Ninlaro), a promising new drug for multiple myeloma, a blood cancer that affects Black people at disproportionately higher rates than white people. In the U.S., 1 in 5 people diagnosed with multiple myeloma are Black people. They are more than twice as likely to get the disease as white people. Yet during the clinical trial of 722 participants, only 13 patients, or 1.8%, were Black.
The American Cancer Society estimates that more than 600,000 Americans will die from cancer this year. Historically, Black Americans have the highest death rate and the shortest survival of any racial or ethnic group, stemming largely, it concluded, from centuries of structural racism.
According to Jamie Freedman, MD, head of U.S. medical affairs at Genentech, a global pharmaceutical company, the lack of diversity is often tied to where studies are run.
“Companies tend to choose major academic medical centers where there is a high volume of clinical trial work. When you go to the same tried and true hospitals repeatedly, the pool of patients becomes very homogeneous and tends to be primarily white,” he says. “It’s critical to bring more trials into the community setting by including new sites that can reach underrepresented groups, and Genentech is making significant progress in that area.”
Freedman believes that while access is a big hurdle, it doesn’t end there.
“Many patients have a lack of trust in the health care system,” he says. “There are also issues around underserved communities being able to afford quality care, so it’s important to keep time and financial burdens in mind when designing trials to help mitigate barriers such as travel, parking, time off work, and child care.”
Genentech started its diversity and inclusion effort several years ago. Freeman says until more trials become diverse, Black Americans will continue to pay the price.
“I think they’re losing their lives in part due to lack of access to these trials. And that is why Genentech and all of us in the health care industry need to change how we design and enroll these studies. We have a long way to go, but I think the steps we’re taking are leading us in the right direction.”
Jennifer Jones-McMeans, PhD, director of global clinical affairs at Abbott Pharmaceuticals, is a clinical research scientist who has designed and led many clinical trials.
She says Abbott is actively working on solutions.
“We have designed our trials to reduce the barriers to participation and expand access,” she says. “This can be as simple as providing transportation services or home visits for those who are housebound. We’re taking it a step further and providing home health services where someone comes to the home and provides follow-up visits there.”
They also provide interpretation services to address any language barriers.
“We are reaching out to a new set of talented investigators who work closely with underrepresented communities. They are very much wedded and supportive of the communities they treat. By working with doctors within these communities, it expands access to new therapies.”
Spokesperson Keanna Ghazvini says Pfizer Pharmaceuticals is also committed to increasing minority participation in trials.
“We know that if historically underserved populations are left out of clinical trials, they risk not benefitting from medical breakthroughs down the line,” she says”
The National Institutes of Health’s National Library of Medicine maintains the clinicaltrials.gov database.
There, you can find information on nearly 372,000 publicly and privately supported clinical trials happening in all 50 states and 219 countries. Many are funded by the National Institutes of Health, but not all of these studies have been evaluated by the U.S. government.
Andrea Denicoff, a nurse consultant at the National Cancer Institute and head of clinical trials operations for the NCI’s National Clinical Trials Network, has been involved in clinical research at the NIH for 35 years.
“It’s really important that our publicly funded trials represent the people of the country,” she says. “There are some cancers that we’re doing a good job in enrolling minorities, and other cancers we need to do a much better job in having a diverse representation in our trials.”
Denicoff believes opening trials in places where people live is key, but having a diverse clinical trials team is as important.
“We need to reinforce that cancer centers across the country have open doors, and anyone with cancer feels comfortable getting care at that center, and that also includes discussing the option to participate in clinical trials when one might be available. We know from research that when people are invited and asked about trial participation and educated about them, they’ll be much more interested in joining them.”
Denicoff says that during the pandemic, the National Cancer Institute quickly came up with guidance to allow trial sites to send patients their oral study drugs and set up virtual visits. She believes it may help increase future access.
‘Lola Fashoyin-Aje, MD, associate director for science and policy to address disparities in the Oncology Center of Excellence at the FDA, says the agency firmly believes clinical trials should represent the patients who will ultimately get the drug if it’s approved.
But the FDA’s power to require diversity in trials is limited.
“It is important to point out that there are legal constraints which limit’s FDA’s authority to require specific proportional representation in clinical trials by demographic factors,” Fashoyin-Aje says
Still, some researchers feel the FDA should play a bigger role. The question is: Should diversity be mandated?
Rhonda Long is now back in Boston to start a new trial, with a new drug that targets her specific mutation. She will be there for 2 months. Once again, Lazarex will help cover some of the cost.
She wants people of color to understand that they are missing out on the promise of new cancer drugs and extended life.
“I feel like there’s not enough emphasis on clinical trials, I don’t believe there’s enough emphasis on second opinions, I don’t think there’s enough emphasis that medicine happens outside our borders, outside of our communities. Clinical trials that don’t have a broad range of participants, how do we know how effective they are if Black and brown people, Asian or Latin American people aren’t represented in the trial?”
And with more trials adopting virtual elements, she says it’s time for minorities to get on board.
Freedman believes the groundwork is being laid for that to happen.
“I don’t think we’ll ever return back to the way we used to do things, where everything has to be done at the clinical trial site. I just don’t think we’re ever going back.”
Hala Borno, MD, assistant professor of medicine, Division of Oncology and Hematology, University of California, San Francisco
Jamie Freedman, head of U.S. medical affairs, Genentech.
Jennifer Jones-McMeans, PhD, director of global clinical affairs, Abbott Pharmaceuticals.
Marya Shegog, PhD, health equity and diversity coordinator, Lazarex Cancer Foundation.
Andrea Denicoff, registered nurse and nurse consultant, National Cancer Institute; chief of clinical trials operations, NCI’s National Clinical Trials Network.
‘Lola Fashoyin-Aje, MD, deputy division director and associate director, science and policy to address disparities, Oncology Center of Excellence, FDA.
Keanna Ghazvini, spokesperson, Pfizer Pharmaceuticals.
FDA: “Drug Trials Snapshots: NINLARO.”
National Cancer Institute: “NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research,” “Inclusion of Women and Minorities as Participants in Research Involving Human Subjects,” “Cancer Disparities.”
Clinicaltrials.gov: “ClinicalTrials.gov Background.”
Lazarex Cancer Foundation.
Genentech Biotechnology Company.
Abbott Laboratories: “Abbott Announces Start Of Trial To Evaluate The New Espri Btk Drug-Eluting Resorbable Scaffold.”
American Cancer Society.
American Society of Clinical Oncology.
Contemporary Clinical Trials: “Does the COVID-19 outbreak identify a broader need for an urgent transformation of cancer clinical trials research?”
The New York Times: “Clinical Trials Are Moving Out of the Lab and Into People’s Homes.”
Massey Cancer Center, Virginia Commonwealth University: “First Lady Jill Biden visits Massey to discuss cancer disparities and community engaged research.”
ProPublica: “Black Patients Miss Out On Promising Cancer Drugs.”