Enabling Community-Based Research Through Policy and Practice Change

Joining a clinical trial in the US today is harder than it should be. Governed by dozens of entities, the system has become fragmented and burdensome. Much of that dysfunction isn't produced by regulation. It's cultural inertia, with practices more restrictive than the rules demand. 

Yet every American should have the opportunity to participate in cutting-edge research and access innovative products that improve their health. That means a system that is patient-centered, embedded in routine care, accessible in communities, and tech-enabled for decentralization and interoperability. 

FasterCures’ Enabling Networks of Research Infrastructure for Community Health through Clinical Trials worked with a 19-member cross-sector working group for more than a year to develop an action plan for change. In this report, we outline eight priority areas: four near-term actions to make trials more patient-centered and four longer-term changes to embed research in care delivery. For each, we identify the challenges, the existing flexibilities that are chronically underused, new actions that can unlock progress, and the actors who must lead. Together, these actions represent a coordinated, systemic plan to build a clinical research system that works for the people it’s meant to serve.