• Annette M Lim, Lachlan McDowell, Chris Hurt, Christophe Le Tourneau, Akihiro Homma, George Shenouda, David J Thomson, Antoine Moya-Plana, Christina Henson, Petr Szturz, Andrew T Day, James E Bates, Smaro Lazarakis, Juliette Thariat, Amanda Psyrri, Hisham Mehanna, Sue S Yom, and HNCIG.
• Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia. Electronic address: annette.lim@petermac.org.
• Lancet Oncol. 2024 Jul 1; 25 (7): e318e330e318-e330.

AbstractRobust time-to-event endpoint definitions are crucial for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head and Neck Cancer International Group investigated endpoint use in phase 3 trials and trials considered potentially practice-changing published between 2008 and 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of the 92 trials reviewed, we show that all core components of endpoint reporting were heterogeneous, including definitions of common terms, such as overall survival and progression-free survival. Our report highlights the urgent need for harmonisation of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details.Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

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