A note on familywise error rate for a primary and secondary endpoint.
closure principle
familywise error rate
group-sequential monitoring
multiple comparisons
primary and secondary endpoints
Journal
Biometrics
ISSN: 1541-0420
Titre abrégé: Biometrics
Pays: United States
ID NLM: 0370625
Informations de publication
Date de publication:
06 2023
06 2023
Historique:
revised:
22
02
2022
received:
20
04
2021
accepted:
14
03
2022
medline:
21
6
2023
pubmed:
1
4
2022
entrez:
31
3
2022
Statut:
ppublish
Résumé
Hung et al. (2007) considered the problem of controlling the type I error rate for a primary and secondary endpoint in a clinical trial using a gatekeeping approach in which the secondary endpoint is tested only if the primary endpoint crosses its monitoring boundary. They considered a two-look trial and showed by simulation that the naive method of testing the secondary endpoint at full level α at the time the primary endpoint reaches statistical significance does not control the familywise error rate at level α. Tamhane et al. (2010) derived analytic expressions for familywise error rate and power and confirmed the inflated error rate of the naive approach. Nonetheless, many people mistakenly believe that the closure principle can be used to prove that the naive procedure controls the familywise error rate. The purpose of this note is to explain in greater detail why there is a problem with the naive approach and show that the degree of alpha inflation can be as high as that of unadjusted monitoring of a single endpoint.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1114-1118Informations de copyright
Published 2022. This article is a U.S. Government work and is in the public domain in the USA.
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