
Commentary|Articles|November 5, 2026
Closing the Community Access Gap: Q&A with Kent Thoelke, Paradigm Health
Author(s)Kent Thoelke, Andy Studna, Senior Editor
In this Q&A, Kent Thoelke, CEO of Paradigm Health, discusses why participation gaps in community and rural settings come down to both patient cost barriers and site infrastructure, how legacy workflows weigh on community clinics, and what policy and technology changes it would take to make clinical research a real care option for more patients.
Advertisement
Advertisement
For most patients in the United States, community and rural clinics are where care happens, yet those same settings are where clinical research is least available. The barriers run in two directions at once: patients who cannot absorb the financial cost of participating, and sites that cannot absorb the administrative weight of running trials on workflows built decades ago.
Related to this article

Community participation gaps look less like a question of patient willingness and more like a financing and infrastructure problem that no single bill has yet solved.

Neuroscience trials struggle to show benefit because symptoms are subjective and variable, and eCOA strengthens dossiers by standardizing ClinRO administration, capturing outcomes in real time to reduce recall bias, and adding patient and caregiver perspectives that clinician scales miss.

In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patients in community and rural settings too often lack access to clinical research as a care option, and how closing that gap could improve outcomes and lower long-term costs.

The FDA’s RTCT initiative transmits predefined, clinically meaningful signals to regulators during active trials, so its value depends entirely on the maturity of sponsors’ upstream RBQM signal intelligence, KRIs, QTLs, and root-cause context, rather than on data speed.

In this video interview, Kent Thoelke, CEO of Paradigm Health, outlines why anti-kickback guidance and modern EHR-integrated trial matching technology must work in tandem to reach representative patient populations at the community level.

In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patient cost barriers and site infrastructure challenges must be solved together to close the participation gap in community and rural clinical trials.

Pacing obesity trial enrollment, anchoring eligibility to stable real-world therapies, and building site and physician relationships improve retention and data quality more than aggressive recruitment or restrictive exclusion criteria do.

In this Q&A, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, discusses what changes when AI is embedded across protocol strategy, data infrastructure, and workflow tools at once, where governance frameworks tend to fall short, and why CROs must orchestrate AI ecosystems rather than simply aggregate them.
Advertisement
Advertisement
