Understanding on the Pooled Test for Controlled Clinical Trialsn

Autor: Hong Laura Lu, Mohammad F. Huque
Rok vydání: 2001
Předmět:
Zdroj: Biometrical Journal. 43:909-923
ISSN: 1521-4036
0323-3847
DOI: 10.1002/1521-4036(200111)43:7<909::aid-bimj909>3.0.co;2-o
Popis: Several independent clinical trials are usually conducted to demonstrate and support the evidence of the efficacy of a new drug. When not all the trials demonstrate a treatment effect because of a lack of statistical significant finding, the sponsor sometimes conducts a post hoc pooled test and uses the pooled result as extra statistical evidence. In this paper, we study the extent of type I error rate inflation with the post hoc pooled analysis and the power of interaction test in assessing the homogeneity of the trials with respect to treatment effect size. We also compare the power of several test procedures with or without pooled test involved and discuss the appropriateness of pooled tests under different alternative hypotheses.
Databáze: OpenAIRE