In 1932, the U.S. Public Health Service began a study on syphilis involving 600 Black men. Despite being promised medical care, these patients were kept in the dark about their disease while doctors studied its progression. In 1943, when penicillin started being used to treat syphilis, the men in the study did not receive it.
In 1951, while seeking treatment for cervical cancer, Henrietta Lacks, a young Black mother of five, had extra tissue removed for research. These cells were the first human cell line able to reproduce indefinitely and have been behind many subsequent medical advancements. She did not consent to having her tissue removed and cells used, and never received compensation.
In 1993, the National Institutes of Health (NIH) Revitalization Act required that research studies include women and people of color. It also set guidelines for their participation, requiring researchers to analyze if the factors being studied affect women and people of color disproportionately.
In 2012, research showed that 80% of clinical trials globally experienced setbacks because of challenges recruiting and retaining participants, delaying the approval of potentially life-saving drugs.
Abuses of power throughout the history of clinical trials with BIPOC (Black, Indigenous, and people of color) have led to mistrust and hesitancy—and building trust going forward is a slow but vital process.
Encouraging other BIPOC to join after positive experience
Dawn Edwards serves on the NIH HEAL Community Partner Committee, consisting of members living with painful conditions or opioid use disorder who offer insight on issues facing them to bolster research. As a Black woman, she understands why BIPOC hesitate to participate in trials.
“Most of what I hear is eugenics, the Tuskegee [syphilis] experiment, ‘they’re just doing tests on us,’ ‘we’re guinea pigs,’ ‘nobody is really trying to help us,’” Edwards says.
Edwards was diagnosed with kidney disease at 23 and, through her advocacy work to support others living with the same disease, was connected with a pain study. “I had no idea what I was doing, I just did it because a physician colleague suggested it, and I trusted him,” she remembers. “And, oh my goodness, everybody was so nice, and they took their time to explain things to me.”
Now, Edwards advocates for other people of color to get involved. “We’re really doing ourselves a disservice as a people by not getting involved in the study process,” she says.
Rebuilding trust: Not just checking off a box
Community outreach is an important factor in rebuilding trust between the medical research field and communities of color.
Working toward this goal is Richard Towne, a Senior Clinical Informatics Manager at Antidote (antidote.me), a clinical trial patient recruitment and patient engagement company working to bridge the gap between new treatments and the individuals who need them. Antidote breaks down the medical jargon and obstacles that make clinical studies difficult to engage with.
Towne stresses accessibility when engaging with communities of color—taking into account the location of the testing site, providing a travel stipend, and laying out the study in digestible terms.
“A lot of the criteria in clinicaltrials.gov are written for the medical staff to screen patients,” Towne says. “So when a patient reads it, they say, ‘I don’t know whether or not I meet these criteria,’ and it can be very overwhelming.”
Edwards urges those conducting community outreach to treat each person as an individual. “Please don’t talk down to us,” she says. “Include us in the conversation so we can understand. Don’t just have us there as a box that you check to say, ‘Yes, I included the community.’”
Towne notes that clinical trials can be a useful tool for patients.
“Especially for pain patients, the treatment options are limited, but there are quite a few trials looking at pain medications,” he says. “And outside the benefit of getting treatment is the thought that as a patient, you can help drive medical research forward.”
Helping others tomorrow by participating in studies today
Stacey Kennedy-Conner got involved with clinical trials at the age of 18, three years after she was diagnosed with lupus.
“I read up on [clinical trials], I asked questions, so I wasn’t really hesitant,” Kennedy-Conner says. “Being a woman of color, African-American, a lot of my family, especially from the South, said, ‘You don’t wanna be a guinea pig.’ So I had that component in the back of my head, but I felt confident.”
Kennedy-Conner, now 35, has taken part in five trials. “This has been such a trying, trying illness, and I don’t want anyone else to go through this,” she says. “I was so young when I was diagnosed, and once I got out of the space of feeling low about it, I just thought, ‘What can I do to support it?’ And clinical trials were one way.”
Now, she meets with other individuals of color who have fears or hesitancy about getting involved in trials.
“Right now, clinical trials feel very distant from the patient,” Kennedy-Conner says. “Be very transparent—it may not help [the patient participating in the trial], but maybe it will help the next person dealing with the disease along the way. I feel like that would make a major difference, especially for communities of color.”