Barriers to Community Trial Enrollment: Lucio N. Gordan, MD

Community oncology practices face steep structural barriers to clinical trial enrollment, and pragmatic trial design that mirrors real-world patient populations could help close the gap, according to Lucio N. Gordan, MD, managing physician and president at Florida Cancer Specialists & Research Institute.

Gordan spoke as part of the panel "Innovation to Implementation: Insights from the 2026 J&J Oncology Care Index" at The American Journal of Managed Care^®’s annual Patient-Centered Oncology Care® conference, held in Nashville, Tennessee, September 24-25, 2026.

Infrastructure and Cost Remain Core Barriers

Gordan responded to Johnson & Johnson’s Oncology Care Index findings showing that 60% of community oncologists report limited clinical trial enrollment options at their practices. He said the difficulty is not surprising given the complexity of building research infrastructure. Establishing a clinical trial program requires substantial investment in staff, including research nurses and coordinators, along with dedicated personnel to manage contracting, compliance, and legal review. These requirements, Gordan noted, create a high financial and operational bar that many practices struggle to clear, even when physicians are motivated to participate in drug development.

When asked about survey data showing that 93% of oncologists believe pragmatic trial design would improve participation, Gordan said trials need to better reflect the patients seen in daily practice.

“A pragmatic clinical trial design needs to mirror what we see in terms of the patient population in real practice,” he explained.

He pointed to eligibility criteria as a key example, noting that patients with stable but imperfect renal or liver function are often excluded under current protocols, even when their condition has been consistent over time. Trials that only accept the healthiest patients do not represent typical clinical populations, he said.

Gordan also emphasized that inclusion and exclusion criteria should align with real-world presentations and that trial design should be patient-centric, reducing the burden of frequent clinic visits. He said a trial’s purpose needs to be compelling enough to justify enrollment given the demands placed on both patients and practices.