Decentralized Trials Hold Promise, but Cost, Infrastructure Challenges Remain: Arturo Loaiza-Bonilla, MD

The clinical trial ecosystem is in transition, shaped by evolving regulatory expectations, funding pressures, and the need to better align research with patient realities, according to Arturo Loaiza-Bonilla, MD, network chief of Hematology and Oncology at St. Luke’s University Health Network and associate professor of medicine at Temple University’s Lewis Katz School of Medicine.

In an interview with The American Journal of Managed Care^® at the April 9 Institute for Value-Based Medicine® event in Philadelphia, Loaiza-Bonilla emphasized that agencies like the FDA are increasingly focused on diversity, speed, and value, pushing sponsors and health systems to rethink how trials are designed and delivered. This shift is prompting a broader change management challenge within institutions, where longstanding processes must adapt to more flexible, patient-centered approaches.

Historically, trial activation has been slow and rigid, often requiring months to open and limiting participation to specific sites. Loaiza-Bonilla noted that this model is giving way to more adaptable frameworks that aim to meet patients where they are in their care journey. However, implementing these changes requires coordination across teams and buy-in from stakeholders who may be accustomed to decades-old workflows.

The greatest strain on trial infrastructure, he said, remains patient identification and enrollment. While artificial intelligence and digital tools can assist with screening, enrollment ultimately depends on human interaction and trust. Centralized trial models further complicate access, underscoring the need for decentralized approaches, including telemedicine, e-consent, and co-management with local providers. At the same time, he pointed to inefficiencies in sponsor-driven protocols, which often mandate unnecessary site-specific procedures, slowing enrollment and increasing burden.

Decentralized and hybrid trial models, which gained traction during the COVID-19 pandemic, remain central to the future of research but face ongoing challenges. Reduced reimbursement for telehealth, high vendor costs, and the collapse of some digital health startups have limited their sustainability. Still, Loaiza-Bonilla sees a significant opportunity to revive these models with a focus on efficiency rather than crisis response.

Looking ahead, he envisions a more seamless system in which patients can be matched to trials digitally, receive much of their care locally or at home, and access specialized services only when necessary, ultimately accelerating enrollment while improving equity and patient experience.

“That's my dream,” he said. “And I'm hopeful that it's going to be part of the whole opportunity that we're looking into.”