Clinical trial outcomes can help inform our understanding of cancer and improve prevention, diagnosis, treatment, and care. But this progress could not happen without the people who choose to participate in and those who connect people with trials. These individuals also work to ensure that trial access is equitable, with the goal of helping all people benefit from studies and their outcomes.

Today’s Clinical Trials are Tomorrow’s Standard of Care

Adine Usher felt a bump on her left breast. Her mammogram just 2 months earlier was negative, but she still had a sinking feeling. It was breast cancer.

At 68 years old, “all I wanted to do was whatever I could to save my life,” she said. She was working as an advocate for children with cerebral palsy, but “it’s scary being your own advocate and doing everything possible to fight for your survival.” Keenly aware of how breast cancer affects her community (African Americans have the highest mortality rate of any racial group), her first step was to find an oncologist she could trust.

                                                                      
Adine Usher, seen here with her grandchildren, participated in the TAILORx breast cancer clinical trial.

Credit: National Cancer Institute

Adine’s friend had been treated by Dr. Joseph Sparano at Albert Einstein Cancer Center through 20 years of late-stage cancer. Adine met with the doctor and they ended up discussing the TAILORx clinical trial, which was enrolling women with early-stage HR-positive, HER2-negative breast cancer. The trial tested whether hormone therapy used alone was as effective as hormone therapy plus chemotherapy based on a woman’s risk of recurrence.

Adine went home and thought about what participating in TAILORx could mean for other women and African Americans. “Being in a clinical trial now could benefit someone like me in the future,” she said. She joined in 2008, and in 2018, results from the trial changed treatment guidelines: 70% of women with this common type of breast cancer do not need chemotherapy after surgery.

Coordinated by a group in NCI’s National Clinical Trials Network (NCTN), “the landmark TAILORx study provided us more clarity about treatment—we’re likely overtreating some patients but undertreating some as well,” said Joseph. Adine was in a group that got chemotherapy, but even now at age 81 and 12 years cancer free, she has never second-guessed her decision. “Doctors don’t make advances or have any kind of impact without patients participating in trials. I knew a trial was important to help others.”

Breaking Old Habits—Expanding Access to Clinical Trials

“They think they’re going to be guinea pigs,” said Dr. Raymond Osarogiagbon, about how rural and minority community members may feel about being in clinical trials. He recalled conversations with one woman’s family about her potential trial participation. “Thirty people came with her, some angry, some scared and wanting to know why I wanted to experiment on their mom,” he said. After he addressed their concerns, the woman did join a trial and is thriving now, more than 10 years later. She even has family members who’ve asked about other trials.

Dr. Raymond Osarogiagbon (left) helps patients like Orion Osborne (right) find the best available treatment options, which sometimes are available only through clinical trials.

Credit: National Cancer Institute

Although clinical trials can provide vital access to treatments, there are “historical moments people recall when the research community has not served people properly, and we continue to be burdened by that,” said Raymond. In his role as director of the multidisciplinary thoracic oncology research program at Baptist Cancer Center in Memphis, TN, he focuses on connecting people diagnosed with lung cancer to a range of treatment options that are sometimes only available through trials.

As an NCI Community Oncology Research Program (NCORP) site, Baptist brings cancer prevention, diagnostics, and care to the traditionally underserved. The center is based in Tennessee but serves much of the Southeast, meaning Raymond sees patients from states with the highest numbers of lung cancer cases and deaths and “some of the worst social determinants of health: high tobacco use, poverty, and poor health care infrastructure.” These communities were left behind, he said, “so let’s stop acting surprised when disparities and mistrust emerge. What’s more important is what we’re going to do about it.”

Clinical trials help broaden access to cancer care, offering patients options like immunotherapy that did not exist 50 years ago. “That's exciting, but none of it has any value,” said Raymond, “if it doesn’t directly benefit all populations.”

It Takes a Village—Helping the Vulnerable Navigate Cancer

They see around 12,000 patients combined a month, many underserved. It’s challenging but rewarding work for the folks at Pittsburgh’s UPMC Hillman Cancer Center and Birmingham Free Clinic. Dr. Linda Robertson (Lyn), Patricia Andres-Sanmartin (Patty), and Lilcelia Williams (CeCe) are part of a network connecting underserved patients with cancer screenings, clinical trials, and other programs to support their health journeys.

Patricia Andres-Sanmartin, Lilcelia Williams, and Dr. Linda Robertson connect people in underserved communities in Pittsburgh, PA, with screening programs and clinical trials.

Credit: National Cancer Institute

For Patty, a Spanish interpreter and patient navigator at Birmingham, language access is especially crucial. “What good is it to have the most wonderful doctor giving the best advice if you don’t understand it?” she said, adding that patients who are elderly, uninsured, immigrants, or non-English speakers can get overwhelmed by the health care system. She’s driven to help because “if we have screening programs and patients who need them but don’t connect the two, they go to waste.”

While clinical trials can be a viable treatment option, patients of color may still feel apprehensive. As a research specialist, CeCe emphasizes the protections in place for trial participants and discusses how “participation is important now and can lead to better outcomes for our children and grandchildren.” Regardless, she said, “the patient is the expert of their body. They are in control. We’re here to guide them but also support them with whatever they decide.”

Lyn, an associate director at Hillman, echoes this message of support and education. “People think being in a clinical trial means getting a placebo or going off treatment,” but that’s not the case, she said. “We’re constantly breaking down what a trial is, what types there are, and why we call them the gold standard of care” through community sessions or even games. “Many communities know us and trust us, but it takes time to achieve that.”

When asked what motivates them, each of these women lit up and said, “the patients,” who they also help with necessities like securing housing or food. Witnessing and addressing barriers to care can be frustrating, but this team remains dedicated to being there for whoever needs them.