301 Head and neck cancer trials are frequently derailed before they can deliver answers. A new analysis suggests that the most common reasons are sponsor decisions related to safety or effectiveness and poor patient recruitment. Researchers from Sylvester Comprehensive Cancer Centre, part of the University of Miami Miller School of Medicine, and collaborators analysed 692 clinical trials launched between 2000–2024. Alex Reznik, an MD/PhD student at the University of Miami and co-author, described the study as “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 findings, published 2nd January 2026 in JAMA Otolaryngology – Head & Neck Surgery, included 346 studies that ended early, either terminated or withdrawn. The leading culprits were: Strategic decisions by sponsors, often unrelated to safety or efficacy (29.5%) Poor patient recruitment (26%) Early-phase trials and those testing immunotherapies or targeted therapies were more likely to fail because of sponsor-driven decisions. Later-phase trials investigating chemotherapy, radiation or combination treatments struggled with enrolment. “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,” said Elizabeth Franzmann, MD, who is a professor of otolaryngology and director of head and neck research at the Miller School and a co-author of the study. Industry-sponsored trials were nearly three times more likely to fail compared with government-funded studies. Academic- and network-funded trials fared better, mainly because they prioritised patient recruitment strategies and broader eligibility criteria. Enrolment size also played a critical role. Trials with higher participant numbers were significantly more likely to reach completion. Conversely, restrictive eligibility criteria and logistical hurdles often doomed studies before they could deliver results. “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,” said first author Janice Huang, an MD/PhD student at the Miller School. Clinical trial failure is not just a research setback. It delays progress for patients and drives up costs. Developing a new cancer drug can cost more than $2 billion, and each terminated trial adds inefficiency to an already complex system. “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,” said Reznik. The study also found that failure rates have climbed steadily over the past two decades, underscoring the need for innovation in trial design. Solutions such as decentralised trials, adaptive protocols and nurse-led navigation could help overcome these barriers. “Clinical trials are how hope becomes care,” said Franzmann.
Head and neck cancer trials are frequently derailed before they can deliver answers. A new analysis suggests that the most common reasons are sponsor decisions related to safety or effectiveness and poor patient recruitment. Researchers from Sylvester Comprehensive Cancer Centre, part of the University of Miami Miller School of Medicine, and collaborators analysed 692 clinical trials launched between 2000–2024. Alex Reznik, an MD/PhD student at the University of Miami and co-author, described the study as “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 findings, published 2nd January 2026 in JAMA Otolaryngology – Head & Neck Surgery, included 346 studies that ended early, either terminated or withdrawn. The leading culprits were: Strategic decisions by sponsors, often unrelated to safety or efficacy (29.5%) Poor patient recruitment (26%) Early-phase trials and those testing immunotherapies or targeted therapies were more likely to fail because of sponsor-driven decisions. Later-phase trials investigating chemotherapy, radiation or combination treatments struggled with enrolment. “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,” said Elizabeth Franzmann, MD, who is a professor of otolaryngology and director of head and neck research at the Miller School and a co-author of the study. Industry-sponsored trials were nearly three times more likely to fail compared with government-funded studies. Academic- and network-funded trials fared better, mainly because they prioritised patient recruitment strategies and broader eligibility criteria. Enrolment size also played a critical role. Trials with higher participant numbers were significantly more likely to reach completion. Conversely, restrictive eligibility criteria and logistical hurdles often doomed studies before they could deliver results. “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,” said first author Janice Huang, an MD/PhD student at the Miller School. Clinical trial failure is not just a research setback. It delays progress for patients and drives up costs. Developing a new cancer drug can cost more than $2 billion, and each terminated trial adds inefficiency to an already complex system. “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,” said Reznik. The study also found that failure rates have climbed steadily over the past two decades, underscoring the need for innovation in trial design. Solutions such as decentralised trials, adaptive protocols and nurse-led navigation could help overcome these barriers. “Clinical trials are how hope becomes care,” said Franzmann.