Rate of Clinical Trial Failure in Head & Neck Cancer Has Grown Since 2000

THURSDAY, Jan. 15, 2026 (HealthDay News) — The rate of early termination or withdrawal in head and neck squamous cell carcinoma (HNSCC) clinical trials (CTs) has increased since 2000, with strategic decisions and poor recruitment as the main reasons, according to a study published online Jan. 12 in JAMA Otolaryngology-Head & Neck Surgery.

Janice J. Huang, from the University of Miami Miller School of Medicine, and colleagues examined the characteristics associated with failure (termination or withdrawal) in CTs for treatment of HNSCC. The analysis included 692 matched trials: 346 trial failures and 346 completed control trials.

The researchers found that the main reasons for failure were strategic decisions (defined as nonscientific, sponsor-driven choices; 102 trials [29.5 percent]) and poor recruitment (90 trials [26.0 percent]). Variation in the reasons for failure was seen by trial characteristics. In phase 1 trials, industry-sponsored trials, and immunotherapy and targeted therapy trials, strategic decisions were the main reason for failure. However, in later-phase trials, non-industry-sponsored trials, and trials investigating chemotherapy, radiation, chemoradiation, combination treatments, and supportive care, poor recruitment was a more common reason for failure. Since 2000, a growing failure rate has been seen among CTs. Increased log-transformed actual enrollment was protective against trial failure, while an independent risk factor was industry funding.

“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,” Huang said in a statement.

Several authors disclosed ties to the pharmaceutical and biotechnology industries.

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