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 

 

Please register by 3pm PST Feb. 25th Monday to ensure smooth check-in. Please send the following information to sfasaofficers@gmail.com :

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