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Activity Number: 615
Type: Contributed
Date/Time: Wednesday, August 12, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #317395
Title: POS Calculation for Binary Endpoint Based on Small Samples
Author(s): Gang Jia* and Yang Song
Companies: Merck and Merck
Keywords: Probability of Success ; Power ; Sample Size ; Binary Endpoints ; Time to Event
Abstract:

Calculation of power and sample size based on estimated effect size has been widely used in statistical study planning. One shortcoming of the approach is that many times the effect size is estimated based on data from small early phase studies and has low precision / high variability. Probability of success (POS) that takes into consideration the variability of estimated effect size is a more appropriate measure for study planning. A simple formula can be used to assess the POS for normally distributed endpoints. Similar formulas using normal approximation can be used for binary endpoints and time to event endpoints. Simulation study will also be presented to illustrate the results.

Authors who are presenting talks have a * after their name.

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