Bringing Phase 1 Clinical Trials to Historically Underserved Patient Populations

Efforts to increase clinical trial participation among patients with cancer has been an uphill battle for decades, with misconceptions about trial protocols and mistrust of the medical community remaining key barriers in many communities. According to the National Institutes of Health, less than 20% of adults diagnosed with cancer participate in clinical trials, with White middle-class men making up the majority (about 85%) of the participant pool. Not only does this mean many patients are missing out on treatments that can improve their quality of life, but the lack of diversity in current trials means that any findings are not necessarily replicable to all patients. For clinical trials to truly benefit all patients with cancer, trial participants need to reflect the actual population. 

Leaders at Mary Bird Perkins Cancer Center, a regional cancer care organization with more than 20 locations in Louisiana and Mississippi, have done more than acknowledge this disparity in clinical trial participation; they've rebuilt their now nationally recognized clinical trials program from the ground up, with diverse enrollment a cornerstone of their philosophy. For its success in bringing in a percentage of minority patients well above the national average for clinical trials, Mary Bird Perkins received a $400,000 grant from the Gilead Foundation from the Gilead Foundation to allow the center to generate more awareness of the benefits of clinical trials and community engagement opportunities. To learn more about Mary Bird Perkins’ approach to clinical trials and the center’s plans for the grant, ACCCBuzz spoke with Victor Lin, MD, PhD, medical director of Clinical Research and Genetics. 

Meeting the Needs of a Large, Diverse Catchment Area 

With a catchment area spanning all of Louisiana plus portions of Mississippi, Mary Bird Perkins casts a particularly wide net for a community practice of its size. In addition, its location in the Deep South places the center in the heart of a heavy cancer belt, where many patients have comorbid conditions and live in underserved rural areas.  

“In many places throughout the region, particularly rural areas, people often don’t have good access to general medical care,” said Dr. Lin. “The work we do in the community is intended to bring high-quality care and cancer screenings to these severely underserved areas that lack medical coverage.” Beyond providing basic preventive medical and oncology care, Mary Bird Perkins is committed to increasing access to clinical trials by bringing them directly to patients’ communities. 

A Philosophical Shift 

When Dr. Lin joined Mary Bird Perkins in 2022, the cancer center was in a time of transition. Formerly, the majority of its research was conducted through the Gulf South Minority Underserved National Cancer Institute (NCI) Community Oncology Research Program (NCORP): a mechanism funded by the NCI to bring cooperative group trials to community cancer centers. As a result, many trials were noninterventional or involved already approved drugs. Rather than bringing new options to patients, they focused on epidemiology, outcomes, and best sequencing of available treatments. 

“When our affiliation with our teaching hospital changed, there was an opportunity to rethink how we approach clinical trials,” said Dr. Lin. A limitation of relying on clinical trials run by cooperative groups is funding, which often leads to studying drugs that are available and sourced through insurance coverage, rather than drugs that are still in active investigation and looking for an indication. 

“We wanted to turn our focus to bringing new drugs to patients,” Dr. Lin explained. “So, we prioritized engaging industry partners, which was not something we had done before, to allow our participants to access certain drugs before they came to market.” 

Before this shift to interventional trials, most patients at Mary Bird Perkins had to travel to Texas, Florida, and Alabama to seek care. “To ask someone to uproot themselves to seek another treatment opportunity—after enduring all the standard-of-care treatments—requiring them to move away from family and friends at this critical time, is not a fair choice,” said Dr. Lin. “Particularly in our area, not everybody has the means to do that. And even if they do, it’s still a difficult choice. You’re deciding on a trade between time spent with loved ones or time pursuing care.” Addressing this need has been a driving force for Mary Bird Perkins, and it remains the heart of its mission with clinical trials. 

An important philosophical shift ushered in by Dr. Lin was turning the focus away from the number of trials open to the number of patients enrolled. “When I first started, I was asked how many clinical trials I planned to open,” he recalled. “I nipped that in the bud right away, because it doesn’t matter how many trials you open if there’s no enrollment.” Dr. Lin stressed the labor involved in opening and maintaining a trial that satisfies regulatory requirements; when staff spend the time and effort completing paperwork, only for no patients to enroll, morale takes a big hit. 

For this reason, Dr. Lin and his team place the emphasis on patient impact rather than the number of trials. “We are very intentional about which trials we open,” he said. “Is it a patient population we’re likely to see, or do we only see 1 case a year?” He also emphasized that for trials testing a new drug in the same class, the drug needs to be appreciably better. If it doesn’t appear to be less toxic or more efficacious, it’s not improving the standard of care. 

Bringing Phase 1 Clinical Trials to the Community 

Phase 1 clinical trials—intended to determine a cancer treatment’s adverse effects and how much is safe to administer—bring a whole new level of complexity and regulatory requirements. Having mainly run noninterventional trials until the last several years, Mary Bird Perkins’ team was very intentional in its selection of phase 1 protocols, understanding that not every trial was a good fit for the center’s capabilities. Early phase 1 protocols, particularly first-in-human studies, often require extended hours, if not 24/7 coverage, due to required pharmacokinetic and pharmacodynamic assays. 

“That said, there is great opportunity in the late phase 1 space where there is already safety data and preliminary efficacy available,” said Dr. Lin. As his team began working with industry partners, the center began to open several late phase 1 trials and enroll patients; in some instances, Mary Bird Perkins was the first center to open a trial in the country and the world. “This is a testament to the strength of our operation. In my old life in academics, we never would have had that opportunity because of bureaucracy,” Dr. Lin remarked. 

While historically there have been few clinical trial opportunities in the state of Louisiana, Mary Bird Perkins has turned that situation on its head, as the center is now seeing patients travel from out of state to seek trials there.  

Moving the Needle in Diverse Representation in Clinical Trials 

Through its affiliation with the Gulf South Minority Underserved NCORP, Mary Bird Perkins has historically placed an emphasis on enrolling patients from minority and underserved backgrounds. Its patient population is approximately 70% White and 30% Black, and the center boasts a diverse enrollment rate of over 20%—several fold over the national average of 5%. Now with its grant from the Gilead Foundation, Mary Bird Perkins is eager to use additional resources to improve this average even more. 

With the South’s long history of misplaced trust in medical authority figures, Dr. Lin emphasized the conscious work Mary Bird Perkins has done to educate community members about how the medical field has changed to earn back their trust. “I believe very strongly that if you’re approaching a patient from a community that has been harmed in the past about a clinical trial, and it’s the first time they’re hearing of it, it’s too late,” he said. “There’s an inherent feeling of ‘What are you trying to get out of me?’ when the information is new and hasn’t been relayed to them by family or friends. We need to meet people where they are through our community outreach programs and educate them before they even need the trial.” 

The center’s grant has allowed them to hire a new clinical trials navigator and a community health worker. The former works with underserved communities to explain the importance of participation in clinical trials and addresses logistical challenges to participation; the latter amplifies Mary Bird Perkins’ Prevention on the Go outreach program and mobile cancer screening units. “The more people hear about these issues from trusted friends and family, the more likely they are to participate in trials and preventive care,” said Dr. Lin. “And when they have good experiences, they evangelize on our behalf, becoming our greatest advocates.”  

A Call to Action for Community Cancer Centers 

Life-saving advances in cancer care are built on the foundation of clinical trials and are becoming a matter of routine for some cancers. From bispecific T-cell engager therapy to antibody-drug conjugates and small molecule inhibitors, cancer research has reached a level of precision thought impossible just decades prior. Over a 30-year span, the death rate from cancer in the US fell by 33%, and much of this decline can be directly traced back to progress made as a result of clinical trials. However, without data reflecting the actual cancer population, advancements stall.  

Mary Bird Perkins’ commitment to reshaping the clinical trial landscape is more than a regional success story—it’s a model for how community-based cancer centers can drive national change. By prioritizing patient access, building trust in underserved communities, and strategically selecting trials that offer real therapeutic promise, the center is not only improving outcomes for its own patients but also helping to redefine what equitable cancer care looks like. As the center continues to expand its reach and impact with support from partners like the Gilead Foundation, it stands as a powerful example of how intentional, community-rooted innovation can move the needle toward more inclusive and effective cancer research.