A new publication developed in collaboration by CTTI, the Duke Clinical Research Institute (DCRI), the Duke Margolis Institute for Health Policy, and Protas published in Trials highlights the current barriers to clinical trial transformation, areas of improvement, and actions needed to transform clinical evidence generation in the United States to better align with clinical care demands. A modern clinical trial infrastructure should prioritize trial accessibility, answer relevant study questions reliably, respond to public health emergencies rapidly, and more. 

The article identifies three key barriers that are currently impeding the transformation of the clinical trial evidence generation system – gaps in policy, inefficient infrastructure, and a lack of research prioritization. The United States’ health and data system has a fragmented infrastructure that can hamper the progress of clinical trials, especially at locations not accustomed to participating in research. Taking advantage of tools that increase trial efficiency will help significantly improve trial activation and participation. Regulatory support and appropriate policies are needed to implement a modern clinical trial infrastructure.  

Lastly, clinical trials are often deprioritized in health care settings because incentives to participate in trials are often limited and/or misaligned with clinical care activities. Health system leadership should encourage integration of trials more routinely into care delivery and help advance a learning health care system, especially as systems implement reforms to improve their clinical data infrastructure. 

Reliable and better evidence can be generated if there is continued movement towards more simple trial designs, regulatory clarity, the creation of a sustainable systemwide infrastructure, and coordinated leadership to improve the research and health care culture.