Review of the statistical analysis of the dog telemetry study.
In 2008, the PSI Toxicology Special Interest Group met to discuss the design and analysis of dog telemetry studies. The dog telemetry study is one component of the integrated cardiovascular assessment required by regulatory bodies. Although there are guidelines for these studies, little is said about the statistical analysis. With parameters of interest measured continually over time, in studies typically involving four dogs, the analysis is not straightforward. This has led to many different types of analysis being proposed in the literature, with many different methods applied within the pharmaceutical industry itself. This paper summarizes the PSI Toxicology group's discussions and recommendations around these issues.
Aylott
Mike
M
Statistical Sciences Europe, GlaxoSmithKline, Harlow, UK. mike.c.aylott@gsk.com
Bate
Simon
S
Collins
Susie
S
Jarvis
Philip
P
Saul
Jim
J
D000818:Animals; D002319:Cardiovascular System / Q000187:drug effects*; D004285:Dogs; D004305:Dose-Response Relationship, Drug; D055808:Drug Discovery / Q000379:methods / Q000706:statistics & numerical data; D004562:Electrocardiography; D008133:Long QT Syndrome; D012107:Research Design; D013686:Telemetry / Q000379:methods / Q000706:statistics & numerical data*; D013997:Time Factors; D016896:Treatment Outcome; D055986:Vital Signs / Q000187:drug effects