Head and neck cancer clinical trials often end before reaching completion, according to a new analysis by researchers at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. The study reviewed 692 clinical trials conducted between 2000 and 2024, focusing on why these studies fail to reach their endpoints.
Alex Reznik, an M.D./Ph.D. student at the University of Miami and co-author, explained, "A retrospective query of head and neck cancer clinical trials in which we compared trial characteristics between failed clinical trials and completed clinical trials."
The research, published on January 2, 2026 in JAMA Otolaryngology – Head & Neck Surgery, found that out of the total studies analyzed, 346 ended early due to termination or withdrawal. Early-phase trials and those testing immunotherapies or targeted therapies were more likely to be discontinued because of sponsor decisions related to safety or effectiveness. Later-phase studies involving chemotherapy or radiation faced difficulties mainly with patient enrollment.
Elizabeth Franzmann, professor of otolaryngology and director of head and neck research at the Miller School as well as a co-author on the study, stated: "Understanding why trials fail is the first step toward designing studies that succeed. Every failure represents lost time for patients who urgently need better options."
The analysis showed that industry-sponsored trials had nearly three times higher failure rates than government-funded ones. Academic- and network-funded studies performed better due to stronger recruitment strategies and broader eligibility criteria.
Enrollment size was also identified as a significant factor; larger participant pools increased the likelihood of trial completion while restrictive eligibility requirements often led to early termination.
Janice Huang, first author and M.D./Ph.D. student at the Miller School said: "Beyond the science, study design plays a critical role in trial success, especially recruitment and eligibility. Recruitment challenges are not just statistics-they reflect real barriers for patients, and digital outreach can help improve access."
Clinical trial failures have financial implications as well; developing a new cancer drug can cost over $2 billion. Each terminated study adds inefficiency to an already complex process. Reznik added: "Often, we think about clinical trial failure as not reaching primary endpoints (e.g., the clinical efficacy required to demonstrate the success of the intervention of interest), however, we decided to investigate the understudied and clinically significant pattern of early trial termination – studies that don't even make it to the finish line."
The report noted an increase in failure rates over two decades. Researchers suggest solutions such as decentralized approaches, adaptive protocols, and nurse-led navigation could help address persistent obstacles.
"Clinical trials are how hope becomes care," Franzmann concluded.
