Last Updated on July 11, 2022 by BVN
Breanna Reeves |
When Curtis Warfield, 62, began his participation in a clinical trial for an immunosuppressant drug, he had Stage 3 Chronic Kidney Disease. He hoped to slow the progression of his renal illness at the time.
He heard a lot of myths about clinical trials, like experimental drugs would make him sick or that he would receive a placebo, but he did his own research to dispel the myths. Today, he urges others to do the same.
“The only thing I saw down the road at that time was just being on dialysis, being more disabled,losing my active life, and wondering how I would take care of my family,” Warfield said. “So, this was an option I saw that would really be beneficial for me.”
Warfield brings awareness about kidney disease and addresses the need for more Black participants in clinical trials. He explained that participating in trials allows participants to take control of their medical situation.
“It helps not only you, but it also helps our communities of color. Most people don’t really understand that,” Warfield said.
Representation matters
According to the American Kidney Fund, Black people in the U.S. account for 35% of Americans with kidney failure, although they make up 13% of the population. They are also 3.4 times more likely to develop kidney failure.
Part of the American Kidney Fund’s advocacy focuses on diversifying clinical trials so that participants reflect the populations that are most impacted by particular diseases or conditions.
The field of kidney disease research isn’t the only reserach field that lacks diversity when it comes to clinical trial participation. Historically, Black people and people of color have been underrepresented in clinical trials and that holds true today across several research fields, including metastatic breast cancer and COVID-19 vaccines.
Patrick Gee is a 58-year-old clinical trial participant who also advocates for diversifying clinical trials and engages with people in his community to discuss joining clinical trials, like he did with the American Kidney Fund. Gee is a five-year kidney transplant recipient who contracted COVID-19 in March 2020.
He signed up to participate in a Johns Hopkins COVID-19 antibodies clinical study for kidney transplant recipients. Gee spoke with the trial coordinators and asked questions about the process before deciding to participate. The study is ongoing and Gee takes a blood test once a quarter and sends it off. He said his care team is always available to answer questions and have difficult conversations.
“It’s about time that we can kind of get beyond some of the past challenges that Black people have had with this,” Gee explained. He said he learned about the low participation rate among Black people in COVID-19 vaccine clinical trials and that such low rates aren’t good.
A John Hopkins publication noted that when Pfizer initially tested their COVID-19 vaccine, 10% of participants were Black people from the U.S., about 4,000 participants. With Moderna, 10% of participants were also Black.
While Gee said he understands Black people’s hesitation to participate in any medical or clinical trials due to the history of medical experimentation on enslaved Black people, he believes “the landscape has changed for Black people to participate.”
As an active clinical trial participant, Gee encourages other people who are curious to ask him questions about his experience, talk to healthcare providers or do their own research about how clinical trials work.
Why diversity in clinical trials is important
The lack of diversity among clinical trial participants may also be attributed to physician or provider bias. In 2019, Marina Pomare Kaplan, an epidemiologist and a metastatic breast cancer patient advocate, presented a poster at the San Antonio Breast Cancer Symposium on increasing participation using patient-driven solutions.
Kaplan found low participation among Black people in her survey and recruited Stephanie Walker, a metastatic breast cancer survivor, to help expand the survey to Black populations. Kaplan passed away in 2020, but Walker continued the research and the project in partnership with the Metastatic Breast Cancer Alliance to launch the Black Experience of Clinical Trials and Opportunities for Meaningful Engagement (BECOME) project.
The BECOME Project report was released in May and found that metastatic breast cancer clinical trials also lack diversity among participants. The survey included 424 respondents, 102 who identified as Black. The report found that 73% of Black respondents said they trusted trials in general, but about 54% of Black respondents said they were not even aware that clinical trials were occurring.
Walker explained that clinical trial participation for Black people is essential when it comes to FDA-approved medications that can be ineffective or less effective for Blacks.
“It matters a lot when it comes down to pharma creating these drugs. I feel that they need to have a patient representative, a Black individual, on board to discuss the plans for the medication, what’s going to be used for the clinical trials,” Walker explained. “We all need to be represented in these trials because eventually it’s going to be us taking these medications.
Advocating for participation
The BECOME report noted that among Black women with metastatic breast cancer, only 40% of Black respondents said they were offered a chance to participate in a clinical trial, but over 80% would consider joining a trial if they had known about one. While this report specifically surveyed Black women with cancer, the results reveal a pattern.
“One of the issues [is] a lot of Black people don’t know about clinical trials. It’s not like a lot of physicians are engaging with Black and brown patients telling them about participating in a clinical trial,” Gee explained. About one in 10 kidney clinical trial participants are Black, according to the American Kidney Fund.
Gee said that while he was undergoing peritoneal dialysis before his transplant procedure, he was interested in participating in a clinical trial and asked his dialysis facility about it. After the facility learned that they would not be compensated for Gee’s participation, they refused to allow him to join the trial.
When Gee asked the facility director why he couldn’t participate, he was directly told: “He who owns the data, owns the patient.”
Unlike Gee, Warfield was told about his clinical trial by his doctor, but he shared that doctors may not always be the one to bring it up, so “you have to bring it to them and kind of force the hand to participate.”
“Take that step forward and believe in yourself, this is a good way to be able to take control of your medical condition and be the boss, instead of sitting back and letting something be told to you that may not be as healthy for you,” Warfield advised.
For those interested in participating in clinical trials, but who are hesitant, Walker explained that participants always have the option of dropping out of a trial at any time if they feel uncomfortable or decide they are no longer interested. Walker also emphasized the importance of asking questions, talking to the clinical trial team and making sure you feel comfortable with participating.