Objective: This study aimed to analyze the use of core outcome sets (COS) in published lung cancer clinical trials, assess the prevalence and characteristics of COS adoption, and evaluate gaps in COS adherence. Background Lung cancer poses significant health challenges, leading to high mortality and financial burdens. To improve data reliability and patient outcomes, standardizing clinical trials through COS is crucial. However, adherence to COS varies, affecting trial comparability and reliability of trial results. To address these issues, COS were developed by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and the Lung Cancer Working Group of the International Consortium for Health Outcomes Measurement (ICHOM). Here, we assess the uptake of COS since its release in 2016, contributing to a better understanding of COS adherence in lung cancer research.

Methods: A cross-section analysis was performed using ClinicalTrials.gov database. Lung cancer trials registered between 2011 through 2023 were screened for inclusion. Trial characteristic data and COS adoption were extracted in a masked, duplicate manner. The frequency of COS outcomes were measured and compared pre and post implementation of COS.

Results: A total of 497 randomized controlled trials (RCTs) met the inclusion criteria from the initial search of 11,183 clinical trials on ClinicalTrials.gov. Most trials were phase 3 (93.8%) and sponsored by industry (66.2%). Health-related quality of life (HRQoL) questionnaires were frequently used (49.7%), while outcomes related to time from diagnosis to treatment, place of death, and duration of time spent in the hospital at the end of life were rarely reported.

Conclusion: Our study uncovered that despite the benefits of standardized COS in lung cancer clinical trials, adherence remains alarmingly low. Disregard for COS compromises data reliability and patient outcomes. The severity of our findings demand attention to ensure a more standardized and reliable approach to lung cancer research.
Original languageAmerican English
StatePublished - 21 Jul 2023
Event7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics - Tandy Conference Center, Tulsa, United States
Duration: 21 Jul 202321 Jul 2023


Conference7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics
Abbreviated title7th Joint Annual Research Meeting
Country/TerritoryUnited States


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