Power analysis for early cardiovascular signal detection
View Presentation Mike Hale, Amgen, Inc. Jing Huang, Amgen, Inc *Ouhong Wang, Amgen, Inc. Keywords: cardiovascular safety, early signal, statistical power It is widely accepted that, due to the small size of first-in-human trials, safety signals are difficult to detect. The chances of detecting early signals in CV safety, including HR, BP, and QT have long been considered remote. However, much of this belief is based on an analysis involving pairwise comparisons of very small cohorts. When dose is considered as continuous, dose-response becomes the main focus and power is improved with appropriate testing procedures. Here, we try to quantify through simulations the power in this setting, and demonstrate that CV safety signals in general have reasonable statistical power for early detection when using a dose-response analysis. The simulations account for different magnitudes of effects and various scenarios including linear, loglinear and Emax relationships between dose and safety, together with multiple parametric and non-parametric tests.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC