Importance: Innovative clinical trials (CTs) are needed to address the rising incidence of head and neck squamous cell carcinoma (HNSCC). Despite adequate trial initiation, HNSCC CTs experience high failure rates, and the factors driving these trends remain unclear.
Objective: To assess the characteristics associated with failure (termination or withdrawal) in CTs for the treatment of HNSCC.
Design and setting: HNSCC CTs were identified on ClinicalTrials.gov from January 1, 2000, to December 31, 2024, and trial failures were defined as early termination or withdrawal. Trial characteristics were compared between failed CTs and completed CT controls. Data were analyzed from June to August 2025.
Main outcomes and measures: The primary outcome was trial failure. The association between failure and CT characteristics, including phase, enrollment, funding source, intervention type, and age-eligibility criteria, was analyzed using descriptive statistics and multivariable regression models.
Results: A total of 692 matched trials were analyzed, including 346 trial failures and 346 completed control trials. The overall leading reasons for failure were strategic decisions (defined as nonscientific, sponsor-driven choices; 102 trials [29.5%]) and poor recruitment (90 trials [26.0%]). The reasons for failure varied by trial characteristics. Strategic decisions were the predominant reason for failure in phase 1 trials, industry-sponsored trials, and immunotherapy and targeted therapy trials. In contrast, poor recruitment was a more common reason in later-phase trials, non-industry-sponsored trials, and trials investigating chemotherapy, radiation, chemoradiation, combination treatments, and supportive care. Temporal analysis revealed a growing failure rate among CTs since 2000. Increased log-transformed actual enrollment safeguarded against trial failure, whereas industry funding was an independent risk factor.
Conclusions and relevance: In this study, HNSCC CTs were terminated early or withdrawn for a variety of reasons, most commonly due to strategic decisions or poor recruitment. Careful attention to trial characteristics associated with early failure is needed to overcome new barriers to drug development and adapt trial design to common reasons for failure.
Importance: Balloon sinus dilation (BSD) is a tool for treating patients with chronic rhinosinusitis or recurrent acute rhinosinusitis. The use of BSD has increased exponentially since its introduction, with concerns for potential misuse. Expert consensus reports that most patients who are candidates for BSD do not need to have all 6 sinuses dilated (bilateral frontal, maxillary, and sphenoid).
Objective: To determine the percentage of patients who are undergoing 6-sinus BSD, evaluate factors associated with this practice, and explore outlier practice patterns when performing 6-sinus BSD.
Design, setting, and participants: This cross-sectional, retrospective review of a Medicare claims database from January 2022 to December 2023 included otolaryngologists (US Centers for Medicare & Medicaid Services code 04) who performed at least 11 BSDs during the study period, who were defined as high-volume BSD clinicians (>10 BSDs per year). Data were analyzed in July 2024.
Main outcomes and measures: The primary outcome defined before data collection as the percentage of patients billed for 6-sinus BSD. Physician variables were explored for potential association with 6-sinus BSD.
Results: Of the 522 otolaryngologists (mean [SD] age, 52 [9.3] years), most physicians were male (489 [94%]), practiced in a group setting (428 [82%]), and were in an urban environment (474 [91%]). A total of 21 290 unique BSD procedures were performed, and 12 799 procedures (60%) involved all 6 sinuses. Of the 522 otolaryngologists, 40 (8%) performed 6-sinus BSD in 100% of their BSD procedures, while 54 (10%) performed no 6-sinus BSDs. Practice patterns varied substantially, with 8 physicians (2%) responsible for 10% of 6-sinus BSDs (n = 2152).
Conclusions and relevance: The results of this cross-sectional study suggest that the high volume of 6-sinus BSD suggests the potential for overuse of BSD. Substantial variations in care emphasize the need for clear guidelines and indications for multisinus BSD to optimize the utilization and value of BSD.
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