Design and monitoring of survival trials in complex scenarios.
delayed treatment effect
intent-to-treat
non-uniform accrual
piecewise exponential
survival trials
treatment crossover
treatment dilution
Journal
Statistics in medicine
ISSN: 1097-0258
Titre abrégé: Stat Med
Pays: England
ID NLM: 8215016
Informations de publication
Date de publication:
30 01 2019
30 01 2019
Historique:
received:
11
12
2017
revised:
03
07
2018
accepted:
28
08
2018
pubmed:
4
10
2018
medline:
7
3
2020
entrez:
4
10
2018
Statut:
ppublish
Résumé
This paper proposes an approach to design and monitor survival trials accounting for complex scenarios such as delayed treatment effect, treatment dilution, and treatment crossover. These scenarios often lead to non-proportional hazards, making study design and monitoring more difficult. We demonstrate that, with event times following piecewise exponential distributions, the log-rank statistic as well as its variance-covariance structure can be easily computed, which greatly simplifies study design and monitoring. As the number of pieces in the exponential distributions can be arbitrary, this approach can handle a wide range of scenarios. Three hypothetical examples are used to demonstrate its potential use.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
192-209Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2018 John Wiley & Sons, Ltd.