P-Value Distribution with Historical Data Borrowing

• Activity Number: 385 - Biomarkers, Endpoint Validation and Other Topics
• Type: Contributed
• Date/Time: Thursday, August 12, 2021 : 12:00 PM to 1:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jasmine Zhang*
• Companies: University of Illinois at Urbana Champaign
• Keywords: P-value; Historical data borrowing; Power

Abstract

P-value is a standard reporting quantity in clinical trials. The distribution of P-value and its applications were well studied in the literature, for example, Hung and O’Neil (Biometrical Journal, 2003). Recently historical data borrowing for clinical trials has increased significantly. Both frequentist and Bayesian approaches have been proposed. In this presentation, I study the distribution of P-Value when historical data is incorporated in the trial design and analysis. The utilities of this distribution are also demonstrated.