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Activity Number: 60 - Real World Evidence in Regulatory Decision Making: Past, Current and Future?
Type: Topic Contributed
Date/Time: Sunday, July 29, 2018 : 4:00 PM to 5:50 PM
Sponsor: Health Policy Statistics Section
Abstract #330057 Presentation
Title: A Glimpse into Industry Experience with RWE to Transform Pharmaceutical Research and Development
Author(s): James Harnett*
Keywords: real world data; real world evidence ; natural language processing; regulatory decisions; R&D ; clinical trials

Pharmaceutical manufacturers, regulators and others are looking at alternative ways to address evidence needs for healthcare decision making. Pharmaceutical companies have leveraged real world data (RWD) extensively to address post-marketing safety and payer real world evidence (RWE) needs and are increasingly applying RWE to research and development (R&D) decisions including addressing inefficiencies in traditional clinical trials. In this presentation, we will discuss the evolution of RWD application to R&D and how RWE can inform new target identification/validation, RCT protocol optimization, create synthetic controls, and yield needed data in a prospective clinical trial. We will also discuss a number of challenges and ways to address RWD quality and silos, value of natural language processing as well as study design, reproducibility, transparency and statistical considerations for RWE generation. A goal of this presentation is to share learnings for collaboration across Industry and other stakeholders to identify how best to use RWE, especially for future regulatory decisions in light of the 21st Century Cures Act and reauthorization of PDUFA VI.

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

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