|
Activity Number:
|
124
- Special Topics in Clinical Trial Design and Analysis
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Monday, July 31, 2017 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
|
Abstract #323568
|
|
|
Title:
|
Simulation-Based Evaluation of P-Value Quality in Phase 3 Clinical Trials
|
|
Author(s):
|
Jihao Zhou* and Ray Zhu and Brandon Wales and Thomas Lin
|
|
Companies:
|
Allergan, Inc. and Allergan, Inc. and University of California at Riverside and University of California at Irvine
|
|
Keywords:
|
p-value ;
reproducibility ;
resampling ;
clinical trial ;
simulation
|
|
Abstract:
|
A p-value is a most widely used measure of evidence against a null hypothesis in statistical testing of hypothesis. In Phase 3 clinical trials, a threshold of 0.05 alpha level is usually used to judge against a calculated p-value to conclude whether there is appropriate statistical evidence to support drug regulatory approval decision. The p-value, being derived from a statistical sample via test statistic, has inherent variability, which is generally ignored or not assessed and thus leads to a lack of understanding of its quality when evaluating study outcome from phase 3 clinical trials. In this paper, we use simulation-based approach to assess the p-value variability from published Phase 3 clinical trials.
|
Authors who are presenting talks have a * after their name.
