Zmax test for delayed effect in immuno-oncology clinical trials.
J Biopharm Stat
; 30(2): 244-266, 2020 03.
Article
em En
| MEDLINE
| ID: mdl-31288599
ABSTRACT
Delayed separation in survival curves has been observed in immuno-oncology clinical trials. Under this situation, the classic log-rank test may confront high power loss. In this paper, we consider a Zmax test, which is the maximum of the log-rank test and a Fleming-Harrington test. Simulation studies indicate that the Zmax test not only controls the Type I error rate but also maintains good power under different delayed effect models. The asymptotic properties of the Zmax test are also established, which further supports its robustness. We apply the Zmax test to two data sets reported in recent immuno-oncology clinical trials, in which Zmax has exhibited remarkable improvement over the conventional log-rank test.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos como Assunto
/
Antineoplásicos Imunológicos
/
Oncologia
/
Neoplasias
Limite:
Humans
Idioma:
En
Revista:
J Biopharm Stat
Ano de publicação:
2020
Tipo de documento:
Article