Clinical trial endpoint use and definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas: HNCIG international consensus recommendations

Annette M. Lim; Lachlan McDowell; Chris Hurt; Christophe Le Tourneau; Akihiro Homma; George Shenouda; David J. Thompson; Antoine Moya-Plana; Christina Henson; Petr Szturz; Andrew T. Day; James Edward Bates; Smaro Lazarakis; Juliette Thariat; Amanda Psyrri; Hisham Mehanna; Sue S. Yom

Clinical trial endpoint use and definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas: HNCIG international consensus recommendations

Annette M. Lim^*, Lachlan McDowell, Chris Hurt, Christophe Le Tourneau, Akihiro Homma, George Shenouda, David J. Thompson, Antoine Moya-Plana, Christina Henson, Petr Szturz, Andrew T. Day, James Edward Bates, Smaro Lazarakis, Juliette Thariat, Amanda Psyrri, Hisham Mehanna, Sue S. Yom^*

^*Corresponding author for this work

Institute for Head and Neck Studies and Education

Research output: Contribution to journal › Article › peer-review

Abstract

Robust time-to-event endpoint definitions are vital for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head Neck Cancer International Group investigated endpoint use in phase 3 or trials considered potentially practice-changing published between 2008 to 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of 92 trials reviewed, we demonstrate 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 harmonization of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details.

Original language	English
Journal	The Lancet Oncology
Publication status	Accepted/In press - 26 Jan 2024

Bibliographical note

Not yet published as of 22/04/2024.

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LimA2024Clinical
Accepted author manuscript, 241 KB
Licence: Creative Commons: Attribution-NonCommercial-NoDerivs (CC BY-NC-ND)
Embargo ends: 20/05/24

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Lim, A. M., McDowell, L., Hurt, C., Tourneau, C. L., Homma, A., Shenouda, G., Thompson, D. J., Moya-Plana, A., Henson, C., Szturz, P., Day, A. T., Bates, J. E., Lazarakis, S., Thariat, J., Psyrri, A., Mehanna, H., & Yom, S. S. (Accepted/In press). Clinical trial endpoint use and definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas: HNCIG international consensus recommendations. The Lancet Oncology.

@article{ae78ca0c26424a5e887082799792429b,

title = "Clinical trial endpoint use and definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas: HNCIG international consensus recommendations",

abstract = "Robust time-to-event endpoint definitions are vital for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head Neck Cancer International Group investigated endpoint use in phase 3 or trials considered potentially practice-changing published between 2008 to 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of 92 trials reviewed, we demonstrate 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 harmonization of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details. ",

author = "Lim, {Annette M.} and Lachlan McDowell and Chris Hurt and Tourneau, {Christophe Le} and Akihiro Homma and George Shenouda and Thompson, {David J.} and Antoine Moya-Plana and Christina Henson and Petr Szturz and Day, {Andrew T.} and Bates, {James Edward} and Smaro Lazarakis and Juliette Thariat and Amanda Psyrri and Hisham Mehanna and Yom, {Sue S.}",

note = "Not yet published as of 22/04/2024.",

year = "2024",

month = jan,

day = "26",

language = "English",

journal = "The Lancet Oncology",

issn = "1470-2045",

publisher = "Elsevier",

}

Lim, AM, McDowell, L, Hurt, C, Tourneau, CL, Homma, A, Shenouda, G, Thompson, DJ, Moya-Plana, A, Henson, C, Szturz, P, Day, AT, Bates, JE, Lazarakis, S, Thariat, J, Psyrri, A, Mehanna, H & Yom, SS 2024, 'Clinical trial endpoint use and definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas: HNCIG international consensus recommendations', The Lancet Oncology.

TY - JOUR

T1 - Clinical trial endpoint use and definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas

T2 - HNCIG international consensus recommendations

AU - Lim, Annette M.

AU - McDowell, Lachlan

AU - Hurt, Chris

AU - Tourneau, Christophe Le

AU - Homma, Akihiro

AU - Shenouda, George

AU - Thompson, David J.

AU - Moya-Plana, Antoine

AU - Henson, Christina

AU - Szturz, Petr

AU - Day, Andrew T.

AU - Bates, James Edward

AU - Lazarakis, Smaro

AU - Thariat, Juliette

AU - Psyrri, Amanda

AU - Mehanna, Hisham

AU - Yom, Sue S.

N1 - Not yet published as of 22/04/2024.

PY - 2024/1/26

Y1 - 2024/1/26

N2 - Robust time-to-event endpoint definitions are vital for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head Neck Cancer International Group investigated endpoint use in phase 3 or trials considered potentially practice-changing published between 2008 to 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of 92 trials reviewed, we demonstrate 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 harmonization of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details.

AB - Robust time-to-event endpoint definitions are vital for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head Neck Cancer International Group investigated endpoint use in phase 3 or trials considered potentially practice-changing published between 2008 to 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of 92 trials reviewed, we demonstrate 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 harmonization of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details.

UR - https://www.thelancet.com/journals/lanonc/issue/current

M3 - Article

SN - 1470-2045

JO - The Lancet Oncology

JF - The Lancet Oncology

ER -

Clinical trial endpoint use and definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas: HNCIG international consensus recommendations

Abstract

Bibliographical note

UN SDGs

Embargoed Document

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Cite this