Joining a clinical trial in the United States remains burdensome and fragmented, governed by dozens of entities and restricted by cultural inertia. To expand real-world patient access, a cross-sector working group has released a comprehensive action plan focusing on near-term patient-centered reforms and long-term delivery changes.
Participating in cutting-edge research across the United States clinical research system often proves far more difficult than necessary. Operating under the oversight of numerous entities, the research infrastructure suffers from systemic dysfunction that stems less from official regulation and more from deeply entrenched cultural habits and restrictive practices.
Every American should have the opportunity to engage with innovative health products. Achieving that goal requires a modernized framework that is patient-centered, embedded directly into routine medical care, available within local communities, and fully supported by interoperable technology.
FasterCures Action Plan and Working Group Structure
To tackle these barriers, the FasterCures initiative known as Enabling Networks of Research Infrastructure for Community Health through Clinical Trials partnered with a 19-member cross-sector working group. The collaboration spanned more than a year of intensive planning to develop a concrete action plan designed to reshape policy and practical execution.
The resulting framework organizes its strategy around eight distinct priority areas.
- Four near-term actions aimed at making clinical trials significantly more patient-centered.
- Four longer-term changes designed to embed research smoothly into daily care delivery.
For each priority area, the report details specific challenges, highlights existing flexibilities that are chronically underused, outlines novel actions to unlock progress, and designates the precise actors who must lead the implementation.
Decentralized Trial Models and Community Oncology Access
Expanding access relies heavily on reaching patients where they already receive routine medical care. Community oncology sites care for a large proportion of patients who could benefit directly from trial participation, yet these facilities often operate with varying capabilities.
Researchers and stakeholders are urged to reassess which traditional trial requirements are strictly necessary to prove safety and efficacy versus those that simply create unnecessary barriers for sites and participants. One promising solution involves a greater reliance on decentralized trial models.
Routine components such as safety assessments and laboratory testing could be performed through a patient’s local community oncologist, even when that specific medical practice is not formally enrolled as a trial site. This operational shift allows patients to participate much closer to home while still generating robust data.
Developing Purpose-Built Studies for Local Delivery
Structuring clinical evaluations to fit community settings requires deliberate planning from the very beginning. Developing purpose-built trials means designing studies specifically to be accessible and deliverable within the communities where patients live and seek care.
By identifying the essential clinical questions a study must answer and then working backward to streamline operational requirements and procedures, researchers can expand participation broadly without compromising clinical data quality.