How Much of the Community Participation Gap Is About Infrastructure, Not Willingness?

Full interview summary

In a recent video interview with Applied Clinical Trials, Kent Thoelke, CEO of Paradigm Health, discussed why participation in clinical research remains out of reach for so many community and rural patients, and what combination of policy change and infrastructure investment it would take to close that gap. He opened by arguing that the participation gap is not a question of patient willingness alone. Cancer patients, in particular, frequently say they would be more interested in trials if sponsors helped offset costs such as lost wages, copays, and travel, and those barriers weigh even more heavily in rural areas where hourly work, limited insurance, and no paid time off are common. At the same time, the sites serving those patients face their own infrastructure challenges, which sponsors can support at a business level in ways they cannot on the patient side.

Thoelke described the administrative weight of legacy trial workflows as a core obstacle for community clinics. Electronic health records were built for billing rather than research, leaving study teams to manually compare complex protocols against patient records to determine eligibility, and then to re-enter data across disconnected systems. Every hour spent on that labor is an hour taken from billable patient care, which constrains how many patients a clinic can screen or enroll.

Making trials scalable, he argued, requires solving both halves of the problem at once: regulatory clarity, such as the OIG’s anti-kickback statute work, that lets sponsors provide financial support to patients, and modern technology such as EHR-integrated trial matching that lets community teams screen at scale. He tied the stakes to access to care itself, noting that most patients receive treatment in community and rural settings and, without trials as a care option, may never reach targeted therapies that match their tumor biology. He closed by calling for policy to go beyond the Clinical Trial Modernization Act, including safe harbor protections, reimbursement safeguards from CMS, and funding mechanisms for community institutions modeled on the EHR meaningful use program.