Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin

Welcome to Automating Quality. Mandy Gervasio is your host, and she's on a mission to bring you hot industry topics with her fellow life sciences partners and friends!

Today's episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.

The topic of today's discussion is the Real-World Evidence framework as defined by the FDA. We highly recommend listening to the previous episode on Real-World Data and Real-World Evidence before diving into this one.

Key Takeaways

00:17 Mandy introduces Ben back to the show

01:13 Today's topic is the Real-World Evidence framework

02:24 What is the FDA's definition of Real-World Evidence?

06:50 What is being looked at for the framework?

09:16 What are the 4 Vs of data?

11:18 How do you define your hypotheses in advance when looking at data?

15:44 Mandy reflects on today's discussion