Abstract:
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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?
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