Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2026
Trial Design, Endpoints and Results Reporting in Interventional Laryngeal Cancer Trials: A Registry-Based Analysis.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Wang Jin, Wu Junfeng, Yang Ziqi, Pei Yihao, Meng Fance, Han Jianmei
Аннотация
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.
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.