Cost evaluation in head and neck cancer clinical trials: implications for high-value care

Rachel G Collins; Ina A Lee; Daniel R S Habib; Desmond C Garner; Douglas B Johnson; Priyesh N Patel; Michael C Topf

doi:10.1016/j.amjoto.2025.104655

Cost evaluation in head and neck cancer clinical trials: implications for high-value care

Am J Otolaryngol. 2025 Apr 28;46(5):104655. doi: 10.1016/j.amjoto.2025.104655. Online ahead of print.

Authors

Rachel G Collins¹, Ina A Lee², Daniel R S Habib¹, Desmond C Garner¹, Douglas B Johnson³, Priyesh N Patel⁴, Michael C Topf⁴

Affiliations

¹ Vanderbilt University School of Medicine, Nashville, TN, United States of America.
² Vanderbilt University School of Medicine, Nashville, TN, United States of America. Electronic address: Ina.lee@vanderbilt.edu.
³ Department of Hematology/Oncology, Vanderbilt University Medical Center, Nashville, TN, United States of America.
⁴ Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, United States of America.

PMID: 40339439
DOI: 10.1016/j.amjoto.2025.104655

Abstract

Background: Clinical trials are crucial in advancing novel therapeutic interventions for head and neck cancer. Given the increased cost of modern healthcare, cost considerations in clinical trials are important yet remain limited.

Methods: A search of ClinicalTrials.gov identified all head and neck cancer studies including cost in the trial description or as a study outcome. Data collected included study type, duration, completion status, enrollment, funding type, cost outcomes, and cost-effectiveness analyses.

Results: Among 2290 head and neck cancer-focused clinical trials, only 76 (3.3 %) mentioned cost in any capacity. Among the trials mentioning cost, 53 (70 %) included cost outcomes and 26 (34 %) included cost effectiveness analyses. Cost was reported as a primary outcome in 5 (0.2 %) clinical trials, a secondary outcome in 32 (1.4 %) trials, and an exploratory outcome in 16 (0.7 %) trials. Most trials (87 %) were interventional, and the most common primary interventions were procedures (25 %) or drugs (14 %). The mean enrollment was 206 participants, and mean duration of the trials was 50 months (SD 47). 73 (96 %) studies have not yet reported results.

Conclusion: The inclusion of cost in head and neck cancer clinical trials is limited, with <3 % of trials including cost endpoints and < 2 % including cost-effectiveness analyses. The paucity of available study results hinders the assessment of the ultimate impact on patients, insurance companies, and healthcare systems. Given the rising cost pressures in modern healthcare systems, the low prevalence of cost endpoints and cost-effectiveness analyses underscores the need for increased awareness and investment in this domain.

Keywords: Clinical trials; Cost; Cost effectiveness; Head and neck Cancer; Health economics; Oncology.