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361 - Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)
Type: Roundtables
Date/Time: Tuesday, August 1, 2017 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #323441
Title: FDA/Industry-Wide Recommended Analyzes and Displays: a Vision Within Reach
Author(s): Sheryl Treichel*
Companies: Amgen
Keywords: PhUSE ; Analyses ; Displays ; Industry ; FDA
Abstract:

A PhUSE Computational Science Working Group is creating white papers describing recommended analysis and reporting methods for frequently collected types of data included in clinical trials and regulatory submissions, with the aspiration of being adapted across industry. An online platform for sharing code has also been created, making these standards easy to implement. In this roundtable discussion, I will share an example of one of the white papers so attendees can gain a understanding of the scope of these white papers. Some of the questions we will discuss are the following. 1. What are the challenges of getting FDA/industry-wide recommended analyses and displays used by companies and regulatory bodies? Can you think of ways to overcome these challenges? 2. How can we raise awareness with medical reviewers (from the FDA and industry) about the existence of these white papers and what ways can we help them become comfortable with adapting the proposed analyses methods and recommended displays?


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

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