Based on a late 2024 survey conducted across HCRN’s network, the report reveals data that underscores the state of investigator-initiated trials (IITs), clinical studies initiated and managed by non-industry investigators (typically academic or independent researchers) who assume the sponsor role. These studies are designed to answer pressing clinical questions, expand therapeutic knowledge, and drive innovation in patient care.  

“More than half of researchers, 58%, said their IITs have had a positive influence, shaped national treatment guidelines, or supported new drug registrations,” said Brian Stemme, chief executive officer of HCRN. “These findings highlight the significant role IITs often play in addressing unmet needs in clinical practice, even as investigators navigate the complexities of funding and trial activation.” 

Chris Fausel, chair of the HCRN Board of Directors, emphasized the role HCRN has long played in supporting researchers at every level.  

“For decades, HCRN has worked closely with researchers, institutions, and funders to answer important clinical questions that are ideally answered through multi-center IITs,” said Fausel. “This new report captures both the opportunities and the obstacles that affect how these trials are conducted and reinforces HCRN’s role.” 

The survey was conducted prior to recent changes in federal research funding and does not reflect the potential impact of these changes. However, these shifts underscore the urgency of aligning resources and collaborative platforms to support the future of IITs. 

The complete report offers a comprehensive, data-driven look at the state of investigator-initiated trials and the trends shaping their future.