Joining a clinical trial in the United States is far more difficult than necessary, and most of the barriers aren't regulatory—they're cultural. A new report from the Milken Institute's FasterCures, published September 30, 2026, finds that the clinical research system has grown fragmented and burdensome under the governance of dozens of entities, with practices often more restrictive than the rules themselves require. The report argues that every American should be able to participate in cutting-edge research and gain access to innovative health products through a system that's patient-centered, embedded in routine care, accessible in communities, and enabled by technology.
FasterCures' Enabling Networks of Research Infrastructure for Community Health through Clinical Trials initiative convened a 19-member cross-sector working group for over a year to craft an action plan for reform. The resulting framework identifies eight priority areas: four near-term actions designed to make trials more patient-centered, and four longer-term changes aimed at embedding research within care delivery. For each priority, the report spells out current challenges, existing flexibilities that remain chronically underused, new actions that could unlock progress, and the stakeholders who need to lead implementation.
According to the report, the dysfunction isn't primarily a product of regulation—it's driven by cultural inertia. The authors note that the United States dedicates nearly 18 percent of its GDP to health care, yet life expectancy has barely improved and health outcomes lag behind those of peer nations. The report frames these eight priority areas as a coordinated, systemic plan to build a clinical research system that actually serves the people it's meant to help, rather than imposing unnecessary obstacles.
The persistence of overly restrictive practices matters because it prevents patients from accessing potentially life-changing therapies and slows the pace of medical innovation. The report's analysis suggests that many gatekeepers and institutions apply standards that go beyond what federal regulations actually mandate, creating bottlenecks that could be eliminated without any change in law. By identifying specific flexibilities already embedded in the current regulatory framework that remain underused, the action plan offers a roadmap for immediate improvement. The emphasis on decentralization and technology reflects the report's view that clinical research should meet patients where they are—in their communities and integrated into the care they already receive—rather than requiring them to navigate a maze of disconnected systems.
The report calls for stakeholders across the clinical trials ecosystem to adopt these eight priority actions as a blueprint for transformation. It recommends that leaders focus first on the four near-term, patient-centered reforms while simultaneously laying groundwork for the longer-term structural changes that would embed research into everyday care delivery. The bottom line: fixing clinical trial access doesn't require sweeping new regulations—it requires challenging the cultural habits that make the system harder to navigate than it needs to be.