Steps on a Journey: Re-Use of Analysis Scripts and Standardized Tuberculosis Trial Data

Time

Tue, Jun 16 9:00AM
T 07

Title

Steps on a Journey: Re-Use of Analysis Scripts and Standardized Tuberculosis Trial Data

Abstract Summary

ORAL PRESENTATION SCHEDULED: Tuesday, June 16 in Session #1A at 10:10 - 10:15 am Location: Exhibit Hall Poster Area (Hall A Entrance)

FDA performed a mock review of trial data to assess use of the TB standard for review, conducted regulatory research on a surrogate endpoint using an integrated TB database and assessed analytic script reuse by comparing analysis data (AdAM) structure from 3 NDAs to the analysis data reviewer guide.

Poster Presenter

Xin (Joy) Li
MSc,
Mathematic Statistician, Office of Translational Science, CDER,
FDA
United States