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Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations

Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations
Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations

Transparent and precise endpoint definitions are a crucial aspect of clinical trial conduct and reporting, and are used to communicate the benefit of an intervention. Previous studies have identified inconsistencies in endpoint definitions across oncological clinical trials. Here, the Head and Neck Cancer International Group assessed endpoint definitions from phase 3 trials or trials considered practice-changing for patients with recurrent or metastatic mucosal head and neck squamous cell carcinoma, published between 2008 and 2021. We identify considerable and global heterogeneity in endpoint definitions, which undermines the interpretation of results and development of future studies. We show how fundamental components of even incontrovertible endpoints such as overall survival vary widely, highlighting an urgent need for increased rigour in reporting and harmonisation of endpoints.

1470-2045
e308-e317
Lim, Annette M.
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Tourneau, Christophe Le
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Hurt, Chris
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Laskar, Sarbani G.
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Steuer, Conor E.
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Chow, Velda L.Y.
cfda35ec-4174-48e1-83bd-09f4599c408a
Szturz, Petr
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Henson, Christina
e1672a9a-2cac-408e-8433-46b08098f42e
Day, Andrew T.
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Bates, James E.
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Lazarakis, Smaro
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McDowell, Lachlan
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Mehanna, Hisham
807d9fab-72ca-47ed-801a-2f5eba8103bf
Yom, Sue S.
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the HNCIG
Lim, Annette M.
2e3950ba-fd3f-4daf-bded-cd7304a99413
Tourneau, Christophe Le
79a38436-31c8-4009-baac-2a3af9b65814
Hurt, Chris
bf8b37a0-8f08-4b47-b3f3-6fc65f7ab87f
Laskar, Sarbani G.
b5d80c8e-dab9-4912-a08a-92ad6ac8814e
Steuer, Conor E.
67bb9702-ed3b-4ef8-ac19-520e3637537b
Chow, Velda L.Y.
cfda35ec-4174-48e1-83bd-09f4599c408a
Szturz, Petr
36c84bfc-78b1-4a79-85ea-3e2fc4f043e2
Henson, Christina
e1672a9a-2cac-408e-8433-46b08098f42e
Day, Andrew T.
95604bf6-86d9-4ba4-aaaf-40231da8b80d
Bates, James E.
b419d7ef-d393-4bb6-b348-fa40c2798c3e
Lazarakis, Smaro
ce679978-644d-49e5-afc9-c51a34edb8c8
McDowell, Lachlan
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Mehanna, Hisham
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Yom, Sue S.
3226a92a-dd3f-4cd4-b976-2e7206270276

the HNCIG (2024) Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations. The Lancet Oncology, 25 (7), e308-e317. (doi:10.1016/s1470-2045(24)00068-8).

Record type: Article

Abstract

Transparent and precise endpoint definitions are a crucial aspect of clinical trial conduct and reporting, and are used to communicate the benefit of an intervention. Previous studies have identified inconsistencies in endpoint definitions across oncological clinical trials. Here, the Head and Neck Cancer International Group assessed endpoint definitions from phase 3 trials or trials considered practice-changing for patients with recurrent or metastatic mucosal head and neck squamous cell carcinoma, published between 2008 and 2021. We identify considerable and global heterogeneity in endpoint definitions, which undermines the interpretation of results and development of future studies. We show how fundamental components of even incontrovertible endpoints such as overall survival vary widely, highlighting an urgent need for increased rigour in reporting and harmonisation of endpoints.

Text
THELANCETONCOLOGY-D-23-00955 - Accepted Manuscript
Restricted to Repository staff only until 24 December 2024.
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e-pub ahead of print date: 24 June 2024
Published date: 24 June 2024

Identifiers

Local EPrints ID: 491709
URI: http://eprints.soton.ac.uk/id/eprint/491709
ISSN: 1470-2045
PURE UUID: b4c51f02-83f1-4ff4-9cba-6cf9e5541f69
ORCID for Chris Hurt: ORCID iD orcid.org/0000-0003-1206-8355

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Date deposited: 03 Jul 2024 16:21
Last modified: 12 Jul 2024 02:16

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Contributors

Author: Annette M. Lim
Author: Christophe Le Tourneau
Author: Chris Hurt ORCID iD
Author: Sarbani G. Laskar
Author: Conor E. Steuer
Author: Velda L.Y. Chow
Author: Petr Szturz
Author: Christina Henson
Author: Andrew T. Day
Author: James E. Bates
Author: Smaro Lazarakis
Author: Lachlan McDowell
Author: Hisham Mehanna
Author: Sue S. Yom
Corporate Author: the HNCIG

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