SFASA Feb.
Seminar -- Feb 27 Wed. 4:30-6pm
"Early
detection of cardiovascular signals – A simulation study about power
enhancement"
¥ Speaker: Jing Huang, PhD., Biostatistics Senior Manager, Medical Science
Biostatistics, Amgen
¥ Time: Feb. 27th Wed. 4:30pm - 6pm
(refreshment starts from 4:30pm, presentation starts from 5pm)
¥ Title: Early detection of
cardiovascular signals – A simulation study about power enhancement
¥ Location: 1120 Veterans Blvd, South San Francisco, CA,
Room 147 (the auditorium on Amgen SSF campus)
¥ Authors: Jing Huang, Ouhong
Wang, Mike Hale
Abstract:
Due to the small size of first-in-human (FIH)
trials, it is natural to assume and has been widely accepted that safety
signals are difficult to detect. The chances of recognizing early signals in
cardiovascular safety, including heart rate, blood pressure, QT prolongation, etc, have long been considered to be remote. However, much
of this belief is based on analyses involving pairwise comparisons of very
small cohorts without incorporating any possible dose-response pattern. When
dose is considered as a continuous variable, dose-response becomes the main
focus and power can be substantially improved with appropriate testing
procedures.
In this project, we use simulation to describe
several common dose-response relationships such as linear, log-linear and Emax; we quantify the power improvement in these settings
by comparing the results derived from simple pair-wise tests versus more
appropriate tests such as Jonckheere-Terpstra test
and tests for recognizing linear and log-linear trends. We demonstrate that
cardiovascular safety signals for small sized FIH studies in general have
reasonable statistical power for early detection when using the appropriate
statistical analysis. The simulations account for different magnitudes of
effect and the common dose-response relationships together with multiple
parametric and non-parametric tests.
Speaker Bio: Dr. Jing Huang is a Biostatistics Senior Manager and has
been working at Amgen for 4 years in Medical Sciences Biostatistics. Before
that, she worked at Affymetrix and Aviir. Dr. Huang received her PhD in Statistics and M.S. in
Epidemiology from Stanford University in 2002. Her public profile online: http://www.linkedin.com/pub/jing-huang/0/b85/431
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