Trial Design, Endpoints and Results Reporting in Interventional Laryngeal Cancer Trials: A Registry‐Based Analysis

OBJECTIVES: To characterize trial design, endpoint emphasis and public results reporting in interventional laryngeal cancer studies. DESIGN: Registry-based descriptive study of trial records. SETTING: ClinicalTrials.gov; records were retrieved on 28 July 2025. PARTICIPANTS: Interventional trials retrieved using the term 'laryngeal cancer' and with a documented start date between 1988 and 2025. MAIN OUTCOME MEASURES: Trial phase, planned enrolment, design features, intervention strategies, registered endpoint domains, results posting and discontinuation. RESULTS: We identified 404 trials. Most were early-to mid-phase with modest enrolment, and masking was recorded in 10.6%. Randomization was documented in 34.7% overall and was more frequent in 2009-2025 than in 1988-2008. Across three study eras, the proportion of trials specifying survival endpoints increased from 34.2% to 68.4%. Quality-of-life or patient-reported endpoints increased from 11.0% to 36.8%, and swallowing endpoints increased from 6.3% to 17.1%. Voice endpoints remained uncommon (3.8%-6.6%), and 21 trials (5.2%) specified an explicit larynx-preservation endpoint. Results were posted for 23.5% of trials, and 16.1% were discontinued. CONCLUSIONS: Registrations increasingly reflect survival and patient-centred priorities, although explicit larynx-preservation endpoints and publicly posted results remain uncommon. Future trials may benefit from larynx-specific designs, consistent assessment of larynx preservation and function with adequate follow-up, and timely dissemination of results.

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Publication Details

Journal
Clinical Otolaryngology
Published
2026-09-30
DOI
https://doi.org/10.1111/coa.70174
Primary Topic
Head and Neck Cancer Studies
Type
article
Field-Weighted Citation Impact
0.00
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article

Trial Design, Endpoints and Results Reporting in Interventional Laryngeal Cancer Trials: A Registry‐Based Analysis

Jin Wang, Ziqi Yang, Junfeng Wu, Yihao Pei et al.
Clinical Otolaryngology
Head and Neck Cancer Studies
article

Trial Design, Endpoints and Results Reporting in Interventional Laryngeal Cancer Trials: A Registry‐Based Analysis

Jin Wang, Ziqi Yang, Junfeng Wu, Yihao Pei, Fance Meng, Jianmei Han
article en

Abstract

OBJECTIVES: To characterize trial design, endpoint emphasis and public results reporting in interventional laryngeal cancer studies. DESIGN: Registry-based descriptive study of trial records. SETTING: ClinicalTrials.gov; records were retrieved on 28 July 2025. PARTICIPANTS: Interventional trials retrieved using the term 'laryngeal cancer' and with a documented start date between 1988 and 2025. MAIN OUTCOME MEASURES: Trial phase, planned enrolment, design features, intervention strategies, registered endpoint domains, results posting and discontinuation. RESULTS: We identified 404 trials. Most were early-to mid-phase with modest enrolment, and masking was recorded in 10.6%. Randomization was documented in 34.7% overall and was more frequent in 2009-2025 than in 1988-2008. Across three study eras, the proportion of trials specifying survival endpoints increased from 34.2% to 68.4%. Quality-of-life or patient-reported endpoints increased from 11.0% to 36.8%, and swallowing endpoints increased from 6.3% to 17.1%. Voice endpoints remained uncommon (3.8%-6.6%), and 21 trials (5.2%) specified an explicit larynx-preservation endpoint. Results were posted for 23.5% of trials, and 16.1% were discontinued. CONCLUSIONS: Registrations increasingly reflect survival and patient-centred priorities, although explicit larynx-preservation endpoints and publicly posted results remain uncommon. Future trials may benefit from larynx-specific designs, consistent assessment of larynx preservation and function with adequate follow-up, and timely dissemination of results.

Clinical Otolaryngology
Guiyang Medical University (CN), Jiading District Central Hospital (CN), Affiliated Hospital of Guizhou Medical University (CN), Medical College of Jinzhou Medical University (CN), Jinzhou Medical University (CN)
Openalex Percentile: Top 9%
Head and Neck Cancer Studies
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