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Activity Number: 15 - Incorporating Knowledge from Previous Clinical Trials into the Design of New Trials
Type: Invited
Date/Time: Monday, August 3, 2020 : 10:00 AM to 11:50 AM
Sponsor: Biopharmaceutical Section
Abstract #309262
Title: Statistical Methods and Process for Historical Data Borrowing in Clinical Trials
Author(s): Lanju zhang* and Zailong Wang and Ivan Chan
Companies: AbbVie Inc and AbbVie Inc and AbbVie Inc
Keywords: Historical Data; Type I error rate; Bayesian; Power prior

Many clinical trials are designed with plenty of historical control data available. To reduce the ever-increasing cost and timeline of the drug clinical development, historical control data are proposed to be incorporated in clinical trial design and analyses. Many statistical methodologies have been proposed, Bayesian and frequentist. Bayesian methods include power prior approach, commensurate prior approach and mixture prior approach. In this presentation, we will discuss a newly proposed statistical approach which combines elements of all the three approaches mentioned above, but admits a closed-form formula for easy implementation. We will demonstrate the approach with a case study and share our interaction experiences with regulatory agencies.

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

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