Online Program Home
My Program

Abstract Details

Activity Number:
Register
368 - Section on Risk Analysis P.M. Roundtable Discussion (Added Fee)
Type: Roundtables
Date/Time: Tuesday, July 30, 2019 : 12:30 PM to 1:50 PM
Sponsor: Section on Risk Analysis
Abstract #307292
Title: The Statistical Footprints in the Path from Real-World Data to Evidence
Author(s): Qian Li*
Companies:
Keywords: Real-world data; Risk analysis
Abstract:

The real-world data and evidence has become a trendy term in many fields, particularly recently in the pharmaceutical industries. In this session, we would like to first discuss the risk of the seemingly promising land on various types of real-world data, such as Electronic Health Record, data collected from wearable electronic devices, and social media. With such understanding, we then discuss strategies, from the statisticians and data scientists’ point of views, that will mitigate the risk for the purposes of scientific discovery, evaluation and validation, and generating evidence for regulatory health authorities. Finally, we would like to simulate scenarios that drugs might be introduced into the real-world without confirmatory studies, how real-world data would fill up the gap to provide convincing safety and efficacy evidence.


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

Back to the full JSM 2019 program