Stacey and her husband, Terry, at a family wedding.
Inclusion Matters: Diversity in Clinical Trials Lays Groundwork for Health Equity
By Kirsten Ellis
At the age of 15, Stacey Kennedy-Conner loved horseback riding. She enjoyed going to church and on vacation with her family. She regularly hit the mall with friends, reimagining the latest clothing trends to create the perfect look. And then she lost the ability to walk.
She had experienced unexplained pain periodically as a child. But following her father’s death in 2003, she went through a severe flare. The pain, weakness, and immobility sent her to the hospital—and led to the diagnosis of systemic lupus erythematosus (SLE), the most common form of lupus.
When her childhood doctor first told her about clinical trials when she was 16, the foundation of trust they’d already built empowered Stacey to consider them—while knowing that her demographic, as a Black woman, has historically been mistreated, excluded, or overlooked in clinical research and pain management.
“She piqued an interest I didn’t even know existed,” Stacey shares. “She explained the background of my illness, what I was up against, and the research that was out there. So I said, ‘You know what? I will be intentional about seeking it out.’”
Stacey was just 20 when she participated in her first clinical trial. It studied the pain-relief efficacy of various dosages of an immunosuppressant medication often used to treat lupus.
The process was brand-new to her, so she was nervous going in—but the research team answered her questions and explained the study until she was comfortable. And that made her willing to keep trying.
“I was awakened to what was out there, what research is happening, and I wanted to be a part of it,” says Stacey, now 38.
EQUITABLE INCLUSION REBUILDS TRUST
The historical mistrust in the health care and clinical trial system among BIPOC (Black, Indigenous, and people of color) is rooted in generations of unethical treatment—perhaps most notably a decades-long study, starting in the 1930s in Tuskegee, Alabama, that examined the effects of syphilis in hundreds of Black men. Researchers failed to collect informed consent, in some cases did not explain to participants that they had syphilis at all, and misled them about being treated—withholding treatment even when penicillin became readily available to address the disease.
“The fear of being purposely tricked or mistreated still echoes in the decisions we make when considering joining a clinical trial or even trusting the health care system as a whole,” Stacey shares.
Today, institutional review boards examine the ethics and patient safety of trial design, and policies and procedures are in place to promote fair treatment in health care. But further work is needed to rebuild trust and ensure diverse representation in clinical research.
“I hope that by sharing my experience, I can encourage others who look like me to see that it’s OK—and important—to join a trial,” Stacey says.
When learning about a new trial, not only does she contemplate whether it’s a good fit for her own care—and discuss it with her rheumatologist, particularly if medication is involved—but she considers whether it’s presented inclusively. She takes note of the location, time requirements, and if materials are delivered in layman’s terms. “Overall, I ask whether there is equitable mindfulness around everyone being able to participate,” she says.
If she chooses to move forward, she pays attention to the rapport she builds with the clinical trial team.
“Are you working with me as if I’m just a number? How am I treated, spoken to, and supported?” she says. “These factors are very important to me and help determine whether I will continue in the trial because I feel safe, or if I will choose to stop.”
SUPPORTING RESEARCH BREAKTHROUGHS
Stacey estimates she’s taken part in close to 10 clinical trials or observational studies. “I’m open to studies because I have such a desire to feel better, to feel my best self,” she says. “Especially if what I’m using isn’t working, I’m very open to trying something new.”
She recently participated in a trial examining the effects of prednisone at different dosages. She uses the corticosteroid, which treats inflammation, as part of her lupus management, taking a daily dose that is increased during a flare. While this particular study did not require her to adjust her dosages, Stacey noted that having a care team she trusts is especially important when she participates in trials where her medication or care is altered.
She often finds out about trials through online lupus communities or information shared by friends and family. And she continues to sign up—not only for herself, but for those who will live with her condition in the future.
“I want to help ensure that effective treatments are available for people newly diagnosed with autoimmune diseases, so they may experience less pain and suffering than I have,” she says. “Being part of research allows me to contribute to advancements that could make a real difference in the lives of others.”
GETTING STARTED: ACCESSIBILITY IS PARAMOUNT
A key piece of improving trial participation is making the process more accessible, Stacey says. Most studies she has participated in have offered some form of compensation, ranging from parking reimbursement to gift cards, to recognize the cost and effort it takes to participate. They also fully cover the devices, care, and lab work needed for the study, and don’t require any involvement from her insurance.
The uptick in decentralized or hybrid trials—which include some level of virtual engagement through tele-visits, phone calls, or self-reporting—has also made research more accessible.
By now, Stacey is well-acquainted with the clinical trial process, but she remembers what it was like being a first-timer with no idea what to expect.
“Talk to your physician about trials—and if not your physician, the nurse practitioner or social worker; someone at the hospital that is your trusted person,” she says. “Learn more about trials and what’s being required of you, and make sure you’re fully aware and you’re knowledgeable.”
She also urges individuals living with pain who want to contribute to research to “start soft, start slow.” Perhaps, rather than starting with a clinical trial studying the effects of a new treatment, which can be time-consuming, look into observational studies. These can involve wearing devices that share data with researchers, or reporting day-to-day symptoms as you go about your routine.
Stacey enjoys these types of studies because of what they teach her.
“Clinical trials often center around the effectiveness of a medication, while observational trials are sometimes more exploratory and examine factors such as mental health, diet, behaviors, and routines,” she explains. “I have found that, in that regard, I learn more about myself and my illness.”
CONTRIBUTING TO A BETTER FUTURE
Stacey and her husband, Terry, have a goldendoodle named Chicken. She credits her family, friends, and faith for supporting her—and motivating her to help others living with pain, too.
A Chicago resident, she works in the educational system, with a focus on family and community engagement. The role provides her with another avenue to help improve life for others.
In addition to SLE, Stacey has also been diagnosed with lupus nephritis and antiphospholipid syndrome. Her conditions cause inflammation-related pain, as well as pain in her joints, head, back, and legs.
Her pain is a roller coaster, sharply twisting from unbearable to manageable and back. In addition to medications, she also relies on heating pads, Epsom salt, stretching, and massage to help manage her symptoms. After living more than half of her life with pain, she is game to try new things.
That’s why she keeps registering for trials—to help herself, and to help others.
“I’ve learned I have a deep, deep desire to put an end to illness and autoimmune issues,” she shares. “I know there will be more people diagnosed, and I want to make their process as easy as possible, because it wasn’t like that for me. I would love to pave the road and make it a little bit easier for men and women that have to deal with this illness.”