Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variables.


Journal Article

To establish noninferiority in QT/QTc prolongation of a test drug with respect to either a placebo or an active control, a thorough QT/QTc study is recommended by ICH (ICH E14, ICH 2005) which concerns statistical inference on the maximal time-matched drug effect. The existing statistical methods for assessing such effects suffer either power loss or parameter restriction. In this paper, we propose a new asymptotic test with small sample correction based on distribution of maximum of correlated random variables under both a parallel-group design and a crossover design. Simulations indicate that our proposed test has adequate powers.

Full Text

Duke Authors

Cited Authors

  • Cheng, B; Chow, S-C; Burt, D; Cosmatos, D

Published Date

  • 2008

Published In

Volume / Issue

  • 18 / 3

Start / End Page

  • 494 - 501

PubMed ID

  • 18470758

Pubmed Central ID

  • 18470758

Electronic International Standard Serial Number (EISSN)

  • 1520-5711

Digital Object Identifier (DOI)

  • 10.1080/10543400802020987


  • eng

Conference Location

  • England