DIA BSWG KOL Lecture Series, L18

Event Date:

10/16/2020

Description:

Speaker: Lanju Zhang, PhD (AbbVie)

Title: Incorporate External Control Data in New Clinical Trial Design and Analysis

Abstract: Many clinical trials are designed with plenty of external control data available. To reduce the ever-increasing cost and timeline of the clinical drug development, external control data are incorporated in clinical trial design and analyses. Two methods can be applied. The first method is to incorporate summary level information into the new trial through a Bayesian framework. 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. The second method is to incorporate subject level external data through propensity score methods. In this presentation, we will share our experiences of using propensity score matching to create a synthetic control arm. We will demonstrate these approaches with case studies and share our interaction experiences with regulatory agencies.

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Starting Time:

11:00 am

Ending Time:

1:00 pm