Keep Patients at the Center of Clinical Research

“The goal, there’s only 1 goal: for all patients to have access to novel therapies, whether they are in rural or urban locations,” emphasized M. Bilal Abid, MD, MS, FACP, MRCP, FRCP, UTHealth Houston McGovern School of Medicine, a panelist for the discussion, “Growing Clinical Trial Infrastructure & Access in Community Oncology” at the 2025 Community Oncology Conference from the Community Oncology Alliance.

M. Bilal Abid, MD, MS, FACP, MRCP, FRCP | Image Credit: © UT Houston McGovern School of Medicine

Abid’s sentiment came toward the end of this panel on day 1 of the conference, but its message was evident in contributions from all of the panelists, who collectively agreed that growing clinical trial infrastructure and access in community oncology remain critical components of ensuring patients cared for in these settings have access to high-quality, cutting-edge therapies close to home.

Katie Goodman, RN, American Oncology Network, moderated this discussion, and in addition to Abid, she was joined by Sunil Babu, MD, Fort Wayne Medical Oncology & Hematology, and Julia Peguero, MD, Oncology Consultants of Houston. Among the topics covered in this discussion were motivating physicians and site management organization to expand clinical research, increasing diversity in clinical trials so they better reflect community demographics, and the importance of patient-centric motivation and ongoing evaluation to drive successful research programs.

Katie Goodman, RN | Image Credit: © American Oncology Network

Meeting Clinical Trial Demand

Goodman opened with some alarming statistics: there’s an expectation of a 49% rise in cancer incidence by 2050 and approximately 2000 new trials start each year in the US while the number of research sites has remained stagnant.

“There’s quite a demand on us to do research today, to open more trials, and to enroll more patients,” Goodman noted. Babu shared his experience as a principal investigator for many phase 1 trials and who oversees a clinical trial program for a team of 15 medical oncologists, and Peguero underscored the significance of being able to provide early drug access, providing the example of a patient once considered for hospice who went on to live for 10 years after gaining early access to immunotherapy, which was “an eye-opener. It is very different when you have somebody who has no options.”

Sunil Babu, MD, | Image Credit: © Fort Wayne Medical Oncology & Hematology

Babu then emphasized that community-based research must fulfill both a patient-centered and a business-centered mission: for patients to gain local access to cutting-edge therapies as practices work to diversify their revenue and elevate their credibility. “There’s that patient-centric part of why we should bring the trials to our own community,” he said, “then there is that business-centric part. It is good business for community oncology to participate in clinical research.” He explained that launching a research program requires a motivated physician and a willingness to start small—academic credential are not required. The most innovative trial does not have to be your first attempt, he continued, nor do you have to go it alone (“Just get off the ground,” he said).

Peguero stressed the role of physician-leaders in transforming underperforming research programs, and Avid explained that clinical research fosters equal access to innovation across diverse populations and adds to the evidence base of therapeutic benefit with real-world data. Together, these factors serve to motivate, inspire a culture of change, and facilitate a long-term vision to success, the panel concurred.

Julio Peguero, MD | Image Credit: © Oncology Consultants of Houston

Supporting Community-Based Research

Site management organizations (SMOs) also are a great resource to help gain experience and to scale up clinical trial operations, Peguero noted. “Linking yourself to an SMO has a lot of value, because there are a lot of headaches that you don’t have to endure.”

Often acting as a bridge between the sponsor and the research site, these entities can become helpful partners when striving to grown a clinical trials program, as they provide specialized services to help clinical trials run smoothly: infrastructure, administrative assistance, and operations streamlining (eg, budgeting, contracting, technology, and payment racking to name a few). They may not be necessary at the onset, but they can help a lot as your clinical trials program grows, Babu explained. They can also assist with negotiating better trial opportunities.

Babu added a caution, however: not all SMOs are created equal. It’s important to work with SMOs that engage with and educate site staff, “with one that collaborates and grows with you.”

It’s also important to consider relationships with SMOs that have national or international footprints, with the panel explaining that phase 1 trials are better suited for highly experienced SMO partners due to their complexity. These partners are better able to provide the necessary level of educational support, broaden access to innovative therapies, and maintain data integrity.

Peguero then pivoted to address developing “a trial menu,” to support burgeoning research, likening this to physician-driven business development” that involves direct engagement through outreach with medical science liaisons and pharmaceutical reps to demonstrate capability and build relationships. “You’re not trained as a physician to be a business development guy,” he said. Therefore, it’s also important to learn from your mistakes; trial and error are part of the process.

Reaching Underserved and Diverse Populations

The final section of this panel discussion focused on strategies to expand clinical trial access to these populations, a topic in the news very much as of late. Topics covered included utilizing technology to broaden access and improve the efficiency of research processes, having the right infrastructure and operational support for equitable research, and being aware of when systemic improvements are necessary,

“There is a lot of conversation around reaching underserved and diverse patient populations for our clinical trial participation,” Goodman stated, “and I think that in the community, we're uniquely positioned to meet that demand.” To that end, platforms need to be focused on lessening the patient burden and not always the trial design.

Reflections were offered on alternative models for growing research, such as partnership with academic centers or building internal capacity and local partnerships for phase 2 and 3 trials to drive sustainable research growth. Academic centers, in particular, are extending outreach through satellites sites and digital platforms to support longer-term trials, such as those investigating cellular therapies, in more remote or suburban areas. Such a digital infrastructure helps to facilitate follow-up and increases representation from historically underrepresented groups.

“We’re so built into diversity from the ethnicity component, that we forget about the rural belt in the US,” Peguero said. “The belts of need for health care are tremendous, are really heartbreaking.”

Practically speaking, the panelists shared that hiring clinical research coordinators who reflect the demographics of the surrounding community was identified as an effective method of building trust, as could translating consent forms and tailoring communications to the populations you are trying to reach that also address social determinants of health. Patient trial-matching tools that incorporate AI were praised for their potential to streamline enrollment and reduce missed opportunities, although the human component to this remains necessary.

The discussion closed with a reminder that successful site-based research begins with a motivated principal investigator and needs to be sustained by a committed multidisciplinary team.

Carrying Research Forward

There is great potential for innovative treatments to have a profound impact on patients who have not had access to clinical trial research and participation, whether because they are members of a historically underrepresented group or live in a location that prevents easy access. These are the patient populations who most need access and awareness of the trials that can bring them to, and to them, innovative and life-saving treatments, with the experts from this panel speaking to the importance of ensuring all patients have access to these novel therapies. The need remains urgent to expand clinical trial access within the community oncology setting.